birth control research paper topics

91 Birth control Essay Topic Ideas & Examples

🏆 best birth control topic ideas & essay examples, 📌 simple & easy birth control essay titles, 👍 good essay topics on birth control, ❓ research questions about birth control.

• Rhetoric: “The Morality of Birth Control” by Margaret Sanger In her speech, Sanger supports the argument that the American women should have the right to learn more about the birth control because of their responsibility for the personal health and happiness in contrast to […]
• Women in Marriage & Sex, Abortion, and Birth Control The historical period chosen is from the eighteenth to the twentieth century to demonstrate the advancement of social structures for women.
• Birth Control on the Level of Individual Woman It was not allowed up to the year 1938, that the court lifted the prohibition of birth control. In my opinion, all women should be allowed to have access to birth control methods.
• Population Increase and Birth Control The end of the 2oth century can be seen as a starting point to the global rivalry between nations, states and continents.
• Human Sexuality Birth Control They include tubal ligation that involves the cutting of the fallopian tube which supplies ova to the uterus for fertilization it can also be done on men through vasectomy which involves the cutting of the […]
• Birth Control, Pregnancy and Childbirth According to Priscilla Pardini who is a re-known scholar in this field of the study states that: “It is can be viewed as a selfish study in the way that an educational institution is studying […]
• Why Teenagers Must Be Allowed to Use Birth Control? It is the purpose of this paper to underscore why teenagers should be given the opportunity to use contraceptives. These findings point to the importance of contraceptives in solving the problem of teenage pregnancy in […]
• Abortions and Birth Control As a result the overall mortality of women increases in the countries where legal abortions take place. The general point of view in decreasing the number of abortions is the use of contraceptives as a […]
• Birth Control for Teenagers This is exactly the reason why the idea of using birth control should not be given to teenagers. The third reason why birth control should not be advocated for teenagers is that there are more […]
• The Birth Control: Safe Methods The first relates to a couple that uses the method correctly every time the couple has sexual intercourse and the latter is for an average couple who actually do not use the method every time […]
• Birth Control Education and Resource Availability for the Prevention of Teen Pregnancy The rationale for this position is mostly based on the fact that teen pregnancy tends to create more complex problems in the future pertaining to the education and literacy rate of the population, the increase […]
• Advanced Pharmacology: Birth Control for Smokers The rationale for IUD is the possibility to control birth without the partner’s participation and the necessity to visit a doctor just once for the device to be implanted.
• Birth Control Methods & Options The male condom is one of the most popular and arguably the least complex methods of contraception. This leads to the prevention of fertilization and interferes with the movement of sperm and effects.
• Birth Control Against Overpopulation Based on the information presented, it can be seen that the current growth of the human population is unsustainable in the long run due to the finite resources on the planet.
• Giving Birth Control to Teenagers It is paramount to say that it is a significant problem that needs to be addressed because the number of cases of teenage childbearing is one of the highest in the United States compared to […]
• Doctors’ Reluctance to Prescribe Birth Control Pills to Early Adolescents These are some of the proposed solutions that could help solve the problem of doctors not prescribing birth control pills to teenagers.
• Why The Regulation Of Birth Control Should Be The Health
• Understanding Your Birth Control Options
• Unaware And Unprotected: Misconceptions Of Birth Control
• The Different Methods of Birth Control in Our Modern Society
• Should Tennagers Be Allowed to Get Birth Control Without Parent Consent?
• The Birth of Birth Control: An essay on Margaret Sanger
• The Consequences of Using Birth Control on the Spread of HIV/AIDS in the United States
• The Effect of Sanger’s Birth Control Movement
• Talking To Your Folks About Starting Birth Control
• Why Birth Control Should Be Readily Accessible To Teenagers
• What You Ought To Know About Emergency Birth Control
• The African American Community and the Birth Control Movement
• Which is the Best Birth Control Method: Pills, Patch, Nuvaring, or Depo Shot
• The Ethical Debate of Free Contraception and Birth Control
• Various Options of Birth Control and Their Effectiveness
• Should High Schools Provide Birth Control Information And Condoms
• To Control or to Not Control: The Government and Birth Control
• Why Parents Should Obtain Birth Control
• Social and Political effects of Birth Control in England
• Uncertain Aims and Tacit Negotiation: Birth Control Practices in Britain, 1925-50
• Taste Buds Outside The Mouth And Male Birth Control
• The Cognitive Response Theory On Birth Control
• The Birth Control Pill: The Pill That Changed America
• Teens Getting Birth Control Without Parental Consent
• The Perspective of Margaret Sanger on Birth Control
• The History of Birth Control and Society
• The Negative Effects of Birth Control for Minors without Parental Consent
• Undergrad: Birth Control and Human Sexuality
• Teenage Girls Should Be Allowed For Get Birth Control Without
• The Misconceptions Of Birth Control In Developing Countries
• Television As Birth Control By Fred Pearce
• Women Have the Burden of Birth Control
• The Problems With the Birth Control Options for the Modern Society’s Teens
• The Pitfalls And Positives Of Abstinence Only Birth Control
• The Question of Whether the Use of Birth Control Increases Promiscuous Sexual Behanvor
• The Lack of Significant Advances for Men’s Health and Male Birth Control
• The Positive And Negative Effects Of Birth Control Pills
• The Pros and Cons of Over the Counter Birth Control Pills
• The Introduction of Birth Control in Things Fall Apart, a Novel by Chinua Achebe
• The Importance Of Educating Adolescents On Various Birth Control Methods
• The Significance of the Introduction of Birth Control for Teens to Prevent Teenage Pregnancy
• The Supply of Birth Control Methods, Education, and Fertility: Evidence from Romania
• The Social Impact of Birth Control in Germany
• The Sexual Activity and Birth Control Use of American Teenagers
• Why Should Birth Control Be Taught in Schools?
• Should Governments Provide Free Access to Birth Control?
• Why Isn’t Birth Control Education Being Taught in Schools?
• How Does Birth Control Affect Society?
• Should Americans Have Easier Access to Contraception?
• Why Should Parents Obtain Birth Control?
• Should Public School Students Be Given Birth Control Pills?
• Does Parental Consent for Birth Control Affect Underage Pregnancy Rates?
• Why Should Women Not Use Birth Control?
• Should Schools Distribute Birth Control?
• How Does Banning Birth Control Affect Women’s Lives?
• Should Birth Control Pills Be Available for Teenage Girls?
• How Does the Birth Control Pill Work?
• Should Birth Control Pills Be Sold Over the Counter?
• How Has Abortion and Birth Control Affected the 20th and 21st Century?
• Should High Schools Provide Birth Control Information and Condoms?
• What Should Women Know About Birth Control Pill?
• Should Teenagers Have Access to Birth Control Without Parent’s Consent?
• Why May Birth Control Patches Be More Dangerous Than Pills?
• Should Teenagers Have Access to Birth Control?
• Why Should Birth Control Be Readily Accessible to Teenagers?
• Should Health Insurance Companies Provide Complete Coverage for Birth Control?
• Does Learning About Birth Control in School Help Prevent Teen Pregnancy?
• Should Pharmacists Be Allowed to Refuse to Fill Emergency Contraception Prescriptions?
• What Are Some of the Current Birth Control Options?
• How Are Federal Reproductive Health Rights Legislation or Denied by State and Local Government?
• What Myths About Health Risks Associated With Contraceptive Devices?
• Should Birth Control Be Taught in School as a Way of Preventing Teen Pregnancy?
• What Are Some of the Religious/Ethical Issues Arising From the Usage of Birth Control?
• What Are Factors to Consider When Choosing the Right Birth Control?
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• Introduction
• Conclusions
• Article Information

This algorithm has not been validated for clinical use. IUD indicates intrauterine device; PATH, Pregnancy Attitudes, Timing, and How important is pregnancy prevention.

This algorithm has not been validated for clinical use. BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared); MEC, Medical Eligibility Criteria for Contraceptive Use.

• Selection, Effectiveness, and Adverse Effects of Contraception—Reply JAMA Comment & Response April 19, 2022 Stephanie Teal, MD, MPH; Alison Edelman, MD, MPH
• Selection, Effectiveness, and Adverse Effects of Contraception JAMA Comment & Response April 19, 2022 Ekaterina Skaritanov, BS; Gianna Wilkie, MD; Lara C. Kovell, MD
• Contraception in Women With Cardiovascular Disease JAMA JAMA Insights August 9, 2022 This JAMA Insights in Women’s Health series summarizes the prevalence of cardiovascular disease among women of childbearing age, the most effective forms of contraception based on the patient’s medical condition and preference, and the risks and adverse effects associated with contraindicated forms of contraception. Kathryn J. Lindley, MD; Stephanie B. Teal, MD, MPH
• Patient Information: Long-Acting Reversible Contraception JAMA JAMA Patient Page October 4, 2022 This JAMA Patient Page describes types of long-acting reversible contraception, how they are placed and removed, and their potential side effects. Elisabeth L. Stark, MD; Aileen M. Gariepy, MD, MPH, MHS; Moeun Son, MD, MSCI
• Patient Information: Medication Abortion JAMA JAMA Patient Page November 1, 2022 This JAMA Patient Page describes medication abortion and its risks and effectiveness. Rebecca H. Cohen, MD, MPH; Stephanie B. Teal, MD, MPH

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Teal S , Edelman A. Contraception Selection, Effectiveness, and Adverse Effects : A Review . JAMA. 2021;326(24):2507–2518. doi:10.1001/jama.2021.21392

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Contraception Selection, Effectiveness, and Adverse Effects : A Review

• 1 Department of OB/GYN, University Hospitals Medical Center and Case Western Reserve University, Cleveland, Ohio
• 2 Department of OB/GYN, Oregon Health & Science University, Portland
• Comment & Response Selection, Effectiveness, and Adverse Effects of Contraception—Reply Stephanie Teal, MD, MPH; Alison Edelman, MD, MPH JAMA
• Comment & Response Selection, Effectiveness, and Adverse Effects of Contraception Ekaterina Skaritanov, BS; Gianna Wilkie, MD; Lara C. Kovell, MD JAMA
• JAMA Insights Contraception in Women With Cardiovascular Disease Kathryn J. Lindley, MD; Stephanie B. Teal, MD, MPH JAMA
• JAMA Patient Page Patient Information: Long-Acting Reversible Contraception Elisabeth L. Stark, MD; Aileen M. Gariepy, MD, MPH, MHS; Moeun Son, MD, MSCI JAMA
• JAMA Patient Page Patient Information: Medication Abortion Rebecca H. Cohen, MD, MPH; Stephanie B. Teal, MD, MPH JAMA

Importance   Many women spend a substantial proportion of their lives preventing or planning for pregnancy, and approximately 87% of US women use contraception during their lifetime.

Observations   Contraceptive effectiveness is determined by a combination of drug or device efficacy, individual fecundability, coital frequency, and user adherence and continuation. In the US, oral contraceptive pills are the most commonly used reversible method of contraception and comprise 21.9% of all contraception in current use. Pregnancy rates of women using oral contraceptives are 4% to 7% per year. Use of long-acting methods, such as intrauterine devices and subdermal implants, has increased substantially, from 6% of all contraceptive users in 2008 to 17.8% in 2016; these methods have failure rates of less than 1% per year. Estrogen-containing methods, such as combined oral contraceptive pills, increase the risk of venous thrombosis from 2 to 10 venous thrombotic events per 10 000 women-years to 7 to 10 venous thrombotic events per 10 000 women-years, whereas progestin-only and nonhormonal methods, such as implants and condoms, are associated with rare serious risks. Hormonal contraceptives can improve medical conditions associated with hormonal changes related to the menstrual cycle, such as acne, endometriosis, and premenstrual dysphoric disorder. Optimal contraceptive selection requires patient and clinician discussion of the patient’s tolerance for risk of pregnancy, menstrual bleeding changes, other risks, and personal values and preferences.

Conclusions and Relevance   Oral contraceptive pills are the most commonly used reversible contraceptives, intrauterine devices and subdermal implants have the highest effectiveness, and progestin-only and nonhormonal methods have the lowest risks. Optimal contraceptive selection incorporates patient values and preferences.

Contraception is defined as an intervention that reduces the chance of pregnancy after sexual intercourse. According to a report from 2013, an estimated 99% of women who have ever had sexual intercourse used at least 1 contraceptive method in their lifetime. 1 Approximately 88% of sexually active women not seeking pregnancy report using contraception at any given time. 2 All nonbarrier contraceptive methods require a prescription or initiation by a clinician. Therefore, contraception is a common reason women 15 to 50 years of age seek health care. 3 This review summarizes current evidence regarding efficacy, adverse effects, and optimal selection of reversible contraceptives. This review uses the terms women and men when the biological expectation for the individual is ovulation or sperm production, respectively.

A search of OVID Medline All, Embase.com, and Ovid Evidence-Based Medicine Reviews–Cochrane Central Register of Controlled Trials for English-language studies was conducted for articles published between January 1, 2000, and June 28, 2021, to identify randomized clinical trials, systematic reviews, and practice guidelines related to contraception or contraceptives. After excluding duplicates and articles not relevant to this review, 2188 articles were identified as potentially relevant via title or abstract content. Thirty-seven articles, consisting of 13 randomized clinical trials, 22 systematic reviews, and 2 guidelines were included. Evidence-based guidelines that used GRADE and systematic reviews were selected for inclusion over individual studies. Clinical practice guidelines from the Society of Family Planning, the World Health Organization, and the American College of Obstetricians and Gynecologists on selected topic areas were reviewed to identify additional key evidence.

The mean age of first sexual intercourse among females in the US is 17 years. 4 Many women typically use contraceptives for approximately 3 decades. 2 The choice of contraceptive is determined by patient preferences, tolerance for contraceptive failure, and adverse effects. Clinicians should elicit patient preferences, identify possible contraindications to specific contraceptives, and facilitate contraceptive initiation and continuation. Clinicians should also be prepared to address misperceptions ( Box ). Some experts recommend screening for contraceptive need at each visit. Two validated screening options, with toolkits available online, are One Key Question and the PATH questions (Pregnancy Attitudes, Timing, and How important is pregnancy prevention). 5 , 6

Commonly Asked Questions About Contraception

What options are available for male contraception? There are currently no Food and Drug Administration–approved contraceptive options for men except condoms. Current male contraceptive methods under evaluation attempt to suppress sperm count to <1 million/mL and include a testosterone plus progestin topical gel.

Are contraceptives associated with increased rates of cancer? Combined hormonal contraceptives, such as combined oral contraceptive pills, protect against endometrial and ovarian cancer. They are associated with an increased risk of early breast cancer diagnosis in current or recent users (ie, within the past 6 mo). The incidence is 68 cases per 100 000 person-years compared with 55 cases per 100 000 nonuser-years. There are no associations of past contraceptive use with increased rates of cancer and there is no association of past contraceptive use and mortality.

Can teenagers use intrauterine devices (IUDs)? Prior guidance suggested restricted use of IUDs by teenagers, nonmonogamous or unmarried, and nulliparous women, but there is no high-quality evidence to support this recommendation. None of these characteristics are true contraindications.

Should all women use the most effective form of contraception? The choice of contraceptive is determined by patient preferences and tolerance for failure. Patients may value other attributes of a method (such as route of administration or bleeding patterns) more highly than effectiveness, and may prefer to have a slightly higher risk of unplanned pregnancy to avoid other adverse effects.

Is the pill as effective for individuals with obesity? Obesity adversely influences contraceptive steroid levels but determining whether this affects contraceptive effectiveness is difficult. The primary reason for contraceptive failure is suboptimal adherence. The use of any method for individuals no matter their weight will prevent more pregnancies than not using a method.

Why are pills not available over the counter (OTC)? Combined hormonal contraceptives are unlikely to be available OTC in the US due to concerns regarding increased rates of thrombosis. Efforts to bring progestin-only pills OTC are progressing.

Quiz Ref ID Reversible contraceptive methods are typically grouped as hormonal (such as progestin-only pills or estrogen-progestin patches) or nonhormonal (condoms, diaphragms) and long-acting (such as intrauterine devices [IUDs]) or short-acting (such as pills). Reversible contraceptive methods can also be grouped by level of effectiveness for pregnancy prevention. Except for behavioral methods, condoms, and spermicide, contraceptive methods are only available by prescription in the US.

Progestins and estrogens are steroid or lipid hormones. Hormonal contraception contains a progestin with or without an estrogen. Progesterone is the only naturally occurring progestin; most contraceptive progestins, such as levonorgestrel and norethindrone, are synthesized from testosterone. Progestins provide a contraceptive effect by suppressing gonadotropin-releasing hormone from the hypothalamus, which lowers luteinizing hormone from the pituitary, which in turn prevents ovulation. 7 , 8 In addition, progestins have direct negative effects on cervical mucus permeability. Progestins reduce endometrial receptivity and sperm survival and transport to the fallopian tube. 9 - 11 Estrogens enhance contraceptive effectiveness by suppressing gonadotropins and follicle-stimulating hormone, preventing the development of a dominant follicle. However, the most important contribution of estrogens to progestin-based contraceptives is the reduction of irregular bleeding. The estrogen component in most combined hormonal contraceptives is ethinylestradiol.

A variety of progestin-only contraceptive methods exists ( Table 1 ). Their effectiveness varies based on dose, potency, and half-life of the progestin as well as user-dependent factors, such as adherence to the prescription schedule. 12 , 13

Progestin-only pills include norethindrone- and drospirenone-containing formulations, which differ in their ability to suppress ovulation. Norethindrone pills contain 300 µg of norethindrone compared with 1000 µg in a typical combined contraceptive pill. The lower amount of progestin in norethindrone pills results in less consistent ovulation suppression and more potential for breakthrough bleeding. The contraceptive efficacy is maintained by other progestin-mediated effects. Drospirenone-only pills contain slightly more progestin than an estrogen and progestin combined hormonal contraception, which aids in ovulation suppression. In one study in which participants delayed their drospirenone-containing pill intake by 24 hours, mimicking a missed dose, ovulation suppression was maintained with only 1 participant of 127 having evidence of ovulation. 14 The benefits of progestin-only contraceptive pills include ease of initiation and discontinuation, fertility return within 1 cycle, safety profile, and minimal effect on hemostatic parameters. 15

Quiz Ref ID Depot medroxyprogesterone acetate (DMPA) is an injectable progestin available in intramuscular (150 mg) and subcutaneous (104 mg) formulations, which are administered at 12- to 14-week intervals. While DMPA is associated with irregular uterine bleeding, this pattern improves with longer duration of use. A systematic review of DMPA-related bleeding patterns (13 studies with 1610 patients using DMPA) found that 46% of those using DMPA were amenorrheic in the 90 days following the fourth dose. 16 DMPA is the only contraceptive method that can delay return to fertility. The contraceptive effect and cycle irregularity can persist for up to 12 months after the last dose, 17 likely due to persistence in adipose tissue and its effectiveness in suppressing the hypothalamic-pituitary-ovarian (HPO) axis. DMPA may be best suited for those who benefit from amenorrhea (eg, patients with developmental disabilities, bleeding diatheses) but not by those who want to conceive quickly after discontinuation. Typical effectiveness of DMPA and progestin-only contraceptive pills is 4 to 7 pregnancies per 100 women in a year. 12 , 18

Quiz Ref ID Progestin-only long-acting methods, such as the levonorgestrel (LNG) IUD and the subdermal implant, have typical effectiveness rates of less than 1 pregnancy per 100 women per year similar to permanent methods, such as tubal ligation or vasectomy ( Table 2 ). 12 , 18 These methods are also associated with return to fertility within 1 cycle after discontinuation. The LNG IUD maintains efficacy for at least 7 years, with amenorrhea rates of up to 20% at 12 months and 40% at 24 months. 19 However, initiation requires an in-person visit with a clinician trained in IUD placement. The etonogestrel subdermal implant is effective for up to 5 years 20 and is easily placed or removed. Initiation and discontinuation also require in-person visits. The bleeding profile of the implant is less predictable and up to 11% of users remove it in the first year due to irregular bleeding. 21 An analysis of 11 studies (923 participants) from Europe, Asia, South America, and the US found that the bleeding pattern in the first 3 months (such as prolonged, frequent, or irregular episodes) is consistent with future bleeding patterns. 21 However, those with frequent or prolonged bleeding in the first 3 months have a 50% chance of improvement in the subsequent 3 months. 21

Combined hormonal methods that contain both estrogen and progestin include the daily oral pill, monthly vaginal ring, and weekly transdermal patch. With full adherence, effectiveness of these methods is 2 pregnancies per 100 users per year. However, typical effectiveness is 4 to 7 pregnancies per 100 women per year, with variability in effectiveness related to the user’s adherence. 12 , 18 The importance of patient adherence to hormonal contraception was recently demonstrated by a cohort study of approximately 10 000 individuals in the US. Pregnancy rates were 4.55 per 100 participant-years for short-acting methods (pills, patch, ring) compared with 0.27 for long-acting reversible methods (IUD, implant). 13 Women younger than 21 years using short-acting methods had higher pregnancy risk as women 21 or older (adjusted hazard ratio, 1.9 [95% CI, 1.2-2.8]). 13 No risk differences by age were observed for the long-acting reversible methods of IUD or implant. Absolute rates were not reported by age stratum.

Combined hormonal contraceptives prevent pregnancy through the same mechanisms as progestin-only methods. Their greatest advantage over progestin-only methods is their ability to produce a consistent, regular bleeding pattern. In a study that compared bleeding diaries from 5257 women using 9 different methods of contraception (nonhormonal, combined hormonal contraception, and progestin-only), approximately 90% of combined hormonal contraception pill users (n = 1003) over a 90-day standard reference period reported regular scheduled withdrawal bleeds while no one experienced amenorrhea. 22 Occasionally, patients do not have a withdrawal bleed during the placebo week. A pregnancy test can be performed if the patient or clinician is concerned about the possibility of pregnancy as the reason for not bleeding. If pregnancy is ruled out, the lack of withdrawal bleeding is due to HPO axis suppression and patients can be reassured that lack of withdrawal bleeding does not indicate a health problem or reduced fertility.

Regardless of the route of delivery, ethinylestradiol and other estrogens are metabolized by the liver and activate the hemostatic system. The most significant risk of combined hormonal contraception is estrogen-mediated increases in venous thrombotic events. 23 - 25 Large international cohort studies have identified the risk of deep vein thrombosis at baseline in reproductive-aged women to be approximately 2 to 10 per 10 000 women-years. The risk associated with combined hormonal contraception is approximately 7 to 10 venous thrombotic events per 10 000 women-years. 26 - 28 The risk of venous thromboembolism is substantially greater in pregnancy. One UK study of 972 683 reproductive-aged women with 5 361 949 person-years of follow-up found a risk of deep vein thrombosis of 20 per 100 000 in women who were not pregnant. This rate increased to 114 per 100 000 women-years in the third trimester of pregnancy and to 421 per 100 000 in the first 3 weeks postpartum. 29 The absolute risk of ischemic stroke in reproductive-aged women not taking combined hormonal contraception is 5 per 100 000 women-years. 25 Combined hormonal contraception is associated with an additional absolute risk of approximately 2 per 100 000 (ie, overall risk of 7 per 100 000). 25 This study did not exclude women who smoked cigarettes or had hypertension. 25

Clinicians who prescribe combined hormonal contraception should counsel women regarding signs and symptoms of arterial and venous thrombosis, especially for women with multiple additional risk factors, including body mass index (calculated as weight in kilograms divided by height in meters squared) at or over 30, smoking, and age older than 35 years. While progestins are not associated with an increase in thromboembolic risks, 30 , 31 US Food and Drug Administration package inserts for these methods contain “class labeling” or the same risks as estrogen and progestin combined hormonal contraceptive methods. Patients at increased risk of thrombosis can be provided a progestin-only, nonestrogen-containing method because this method of contraception does not increase risk of venous thromboembolism. 32

Behavioral contraceptive methods include penile withdrawal before ejaculation and fertility awareness–based methods. Imprecise terms, such as natural family planning , the rhythm method , or other euphemisms may be used by patients when referring to these methods. The effectiveness of withdrawal and fertility awareness depends on patient education, cycle regularity, patient commitment to daily evaluation of symptoms (first morning temperature, cervical mucus consistency), and the patient’s ability to avoid intercourse or ejaculation during the time of peak fertility. Data on pregnancy rates are frequently of poor quality and highly dependent on study design. 33 A meta-analysis of higher-quality prospective studies of women at risk for undesired pregnancy reported failure rates of 22 pregnancies per 100 women-years for fertility awareness methods. 34

Other nonhormonal methods prevent sperm from entering the upper reproductive tract through a physical barrier (condoms and diaphragms) or through agents that kill sperm or impair their motility (spermicides and pH modulators). First-year typical use effectiveness for these methods is 13 pregnancies per 100 women in a year. 12 , 18

The copper-bearing IUD is a highly effective nonhormonal reversible method. 12 , 18 Typical use pregnancy rates are 1% per year. 12 , 18 There is no effect on a user’s HPO axis and thus ovulation and menstrual cyclicity continues. The primary mechanism of action is spermicidal, through direct effects of copper salts and endometrial inflammatory changes. 35 The major challenge with the copper IUD is that it can increase the amount, duration, and discomfort of menses mostly during the first 3 to 6 months of use. 36 IUD use does not increase later risk of tubal infertility. 37 If sexually transmitted infection (STI) testing is indicated, testing can be performed concurrently with IUD placement. 38 - 40 This expedited process of testing for STIs at the time of IUD placement does not increase the risk of pelvic inflammatory disease. The absolute risk of pelvic inflammatory disease after IUD insertion is low in those with (0%-5%) or without (0%-2%) existing gonorrhea or chlamydial infection. 41

Emergency contraception (EC) reduces pregnancy risk when used after unprotected intercourse. The most effective method of EC is a copper IUD, which reduces pregnancy risk to 0.1% when placed within 5 days of unprotected intercourse. 42 A copper IUD also has the added advantage of providing patients with ongoing contraception. LNG IUDs were not previously considered an option for EC. However, in a recent randomized noninferiority trial, women requesting EC who had at least 1 episode of unprotected intercourse within the prior 5 days were randomized to receive a copper IUD (n = 356) or a 52-mg LNG IUD (n = 355). 43 LNG IUD was noninferior to copper IUD (between-group absolute difference, 0.3% [95% CI, −0.9% to 1.8%]). However, the proportion of study participants who had unprotected intercourse midcycle (and therefore were at risk of pregnancy) was not reported. If a patient needs EC and wishes to initiate a 52-mg LNG IUD, it is reasonable to immediately place the IUD plus give an oral EC, 44 given the limited and indirect evidence supporting the LNG IUD alone for EC.

Quiz Ref ID Oral EC consists of a single dose of either a progestin (LNG, 1.5 mg) or an antiprogestin (ulipristal acetate, 30 mg). Both of these agents work by blocking or delaying ovulation. Neither is abortifacient. LNG EC is available over-the-counter; a prescription is needed for ulipristal acetate. The medication should be taken as soon as possible after unprotected intercourse for maximum efficacy but can be taken up to 5 days afterward for ulipristal acetate. 45 - 47 LNG efficacy is diminished after 3 days. Efficacy appears similar between the 2 agents when ingested within the first 72 hours after intercourse (ulipristal acetate EC: 15 pregnancies of 844, LNG EC: 22 pregnancies of 852; reduction in pregnancy without EC use estimated to be 90% less) but pharmacodynamic and clinical studies demonstrated that the ulipristal acetate treatment effect persists up to 120 hours with no pregnancies (0/97). 46 Actual use studies of EC that included 3893 individuals found lower pregnancy prevention rates than expected, which appears to be related to multiple acts of unprotected intercourse both before and after the EC use. 48 , 49 If further acts of unprotected intercourse occur 24 hours after EC use and a regular method of contraception has not been started, EC needs to be taken again. 49 Repeat use of LNG EC results in no serious adverse events; repeat dosing for ulipristal acetate EC has not been specifically studied. 50 Clinicians should review the options for EC with all patients starting a user-controlled method, such as condoms. These patients may be prescribed oral EC to keep at home for immediate use if needed.

Two evidence-based guidelines are available to assist clinicians in evaluating the safety of contraception initiation and use. 32 , 42 These guidelines were developed by the US Centers for Disease Control and Prevention, are updated regularly, and are freely available online and in smartphone apps.

The first is the US Medical Eligibility Criteria for Contraceptive Use 32 (US MEC), which provides information on the safe use of contraceptive methods for women with various medical conditions (eg, diabetes, seizure disorder) and other characteristics (eg, elevated body mass index, tobacco use disorder, postpartum). The US MEC uses a 4-tiered system to categorize level of risk for each disease/contraceptive method combination. 32 The risk tiers are (1) no restrictions exist for use of the contraceptive, (2) advantages generally outweigh theoretical or proven risks although careful follow-up might be required, (3) theoretical or proven risks outweigh advantages of the method and the method usually is not recommended unless other more appropriate methods are not available or acceptable, and (4) the condition represents an unacceptable health risk if the method is used. 32

All clinicians, including advanced practice clinicians, should be familiar with prescribing within US MEC categories 1 and 2 (no restrictions or benefits outweigh risks). For women with underlying health conditions who want to use a category 3 method, such as a woman with a history of breast cancer choosing combined hormonal contraceptives, primary care physicians or specialists should review the detailed evidence listed in the US MEC to advise their patients. Subspecialists in complex family planning who have completed extra fellowship training may provide helpful consultation for patients with multiple contraindications or unusual situations. The US MEC is a guideline, not a mandate. Situations may arise in which specialists recommend an MEC category 3 or 4 method because the alternative to the contraceptive method, pregnancy, places the patient at even greater risk. 32 The US MEC does not include conditions for which there is insufficient evidence to make recommendations, such as aortic aneurysms, Marfan syndrome, or chronic marijuana use. For these patients, clinicians should consider referral to a complex family planning specialist. If the patient needs a method immediately, a progestin-only pill should be considered as a “bridging” method, because these can be used safely by most patients 32 and are more effective than barrier methods such as condoms.

The US MEC addresses common drug interactions with hormonal contraceptives. 32 Contraceptive steroid hormones are metabolized via the hepatic cytochrome P450 pathway. 51 , 52 Drugs that induce this pathway, such as rifampin and barbiturates, or chronic alcohol can impair contraceptive efficacy and drugs that inhibit the pathway, such as valproic acid, cimetidine, or fluconazole, may increase adverse effects. The FDA recognizes a drug-drug interaction as clinically significant if it causes at least a 20% difference in drug levels 53 but an interaction does not necessarily affect contraceptive failure rates. Adherence, continuation, fecundity, and frequency of intercourse also contribute to contraceptive effectiveness. Additionally, most pharmacokinetic studies do not have sufficient statistical power to determine differences in pregnancy rates. The most common drug classes that may interact with hormonal contraceptives are antiretroviral drugs (including efavirenz and ritonavir-boosted protease inhibitors) and anticonvulsant therapies (including carbamazepine, phenytoin, and others). 54 , 55 Evidence from both clinical and pharmacokinetic studies of routinely used antibiotics do not support impaired contraceptive efficacy with concomitant antibiotic prescription, 56 except for rifampin with which ethinylestradiol and progestin area under the curve levels are at least 40% lower. 57 Because the local progestin dose in the LNG IUD is so high, its efficacy is not reduced by drugs that may affect combined hormonal contraceptives, progestin-only contraceptive pills, or the progestin implant. While hormonal contraceptive use can change concentrations of some drugs, 58 this is rarely clinically relevant, except for the reduction in serum concentration of the anticonvulsant lamotrigine.

Another major guideline is the US Selected Practice Recommendations for Contraceptive Use 42 (US SPR, available online or via a smartphone app). The US SPR is organized by contraceptive method. It includes method-specific, up-to-date guidelines, such as how to initiate the method, how to manage bleeding irregularities, and recommended follow-up. For example, the guidelines on IUDs include evidence on medications to ease IUD insertion or IUD management if a pelvic infection occurs. Recommendations related to combined hormonal contraceptives include the number of pill packs that should be provided at initial and return visits or management of vomiting or severe diarrhea while using combined oral contraceptives.

Much of the data on noncontraceptive benefits of hormonal methods come from case-control studies or small comparative trials. However, fair evidence exists that methods that suppress ovulation can be effective in reducing benign ovarian tumors 59 and functional ovarian cysts. 60 Combined hormonal contraceptives diminish hormonally mediated premenstrual dysphoric disorder, with statistically significant mean differences in symptoms, such as headaches, bloating, and fatigue, and functionality scales. 61 The estrogen component of combined hormonal contraception increases hepatic sex hormone–binding globulin, which reduces free testosterone and improves androgen-sensitive conditions, such as acne and hirsutism. Cochrane systematic reviews of combined hormonal contraceptives and both conditions show significant associations with improvement in a variety of measures of acne and hirsutism. 62 , 63 All progestin-containing contraceptives cause endometrial atrophy and, thus, reduce menstrual blood loss and menstrual pain to varying extents. 64 - 66 While progestin-only methods can promote unscheduled or breakthrough bleeding, the total amount of blood loss is reduced and in those with heavy menstrual bleeding, hemoglobin levels can rise by 10 g/L in 12 months. 67 , 68 The LNG IUD has demonstrated efficacy in reduction of heavy menstrual bleeding 69 , 70 (including for women with anticoagulation, fibroids, 71 or hemostatic disorders), primary dysmenorrhea, 36 , 72 endometriosis, 73 adenomyosis, 74 and protection against pelvic infection. 75

Screening for pregnancy is important prior to prescribing contraception. According to the US SPR, clinicians should be “reasonably certain” that the patient is not pregnant. 42 A clinician can be reasonably certain that a woman is not pregnant if she has no symptoms or signs of pregnancy and meets any 1 of the following criteria: (1) is 7 days or less after the start of normal menses; (2) has not had sexual intercourse since the start of last normal menses; (3) has been correctly and consistently using a reliable method of contraception; (4) is 7 days or less after spontaneous or induced abortion; (5) is within 4 weeks’ postpartum; and (5) is fully or nearly fully breastfeeding (exclusively breastfeeding or most [≥85%] of feeds are breastfeeds), amenorrheic, and less than 6 months postpartum.

Quiz Ref ID These criteria have a negative predictive value of 99% to 100%. 76 - 78 A urine pregnancy test (UPT) alone is not sufficient to exclude pregnancy. UPT sensitivity is dependent on when the last act of intercourse occurred, the ovulatory cycle phase, and urine concentration. Sensitivity of UPTs is 90% at the time of a missed period, but only 40% in the week prior. 79 Additionally, a UPT can remain positive up to 4 weeks after delivery, miscarriage, or abortion. 80 , 81 Few other tests are required for safe and effective use of contraception.

Clinicians can offer other indicated preventive health tests at the contraceptive initiation visit, like screening for cervical cancer or STIs. However, these tests are not required for contraceptive use and should not prevent initiation of contraception.

Generally, all methods should be started immediately on prescription regardless of menstrual cycle day—known as the Quick Start protocol. 82 If a hormonal method is initiated within 5 days of the first day of menses, no additional backup method is needed. At other times in the cycle, or when switching from a nonhormonal to a hormonal method, a backup is necessary for 7 days to ensure ovulation suppression. If switching from one hormonal method to another, the switch can occur without a withdrawal bleed or backup.

If a woman reports unprotected intercourse within the 5 days before contraceptive initiation, most sources recommend giving emergency contraception, initiating her desired method, and repeating a UPT 2 to 3 weeks later. 82 - 85 Many studies have demonstrated that exposing an early pregnancy to hormonal contraception is not harmful 86 but delayed initiation increases the risk of undesired pregnancy.

Because comparative effectiveness studies to clearly identify the superiority of one contraceptive pill formulation over another are lacking, selecting a contraceptive pill often depends on patient experience. Monophasic regimens, in which each pill has the same hormone doses, have significant advantages over bi- and triphasic regimens. Cycles can be extended easily by skipping the placebo week and starting the next pack of active pills. If this is attempted with multiphasic regimens, the drop in progestin between phases typically results in breakthrough bleeding. In terms of ethinylestradiol, few patients require a pill containing more than 35 µg/d to prevent breakthrough bleeding. 87 Many clinicians advocate starting with the lowest ethinylestradiol dose to minimize risks. However, there are no data demonstrating that 10- to 20-µg/d ethinylestradiol doses are safer than 35 µg daily, and lower ethinylestradiol doses are associated with more unscheduled vaginal bleeding. 88 Thus, starting with a monophasic preparation containing 30 µg to 35 µg of ethinylestradiol provides the greatest likelihood of a regular bleeding pattern without increasing risk. Ethinylestradiol can be reduced if patients have estrogen-associated adverse effects, such as nausea or breast tenderness.

Many different progestins exist. Progestins differ in in vitro androgenicity, effects on surrogate metabolic markers, or similarity to testosterone. 89 While molecular structures differ, there is no evidence demonstrating that a particular progestin is superior to others. Traditionally, progestins were classified into “generations” by their parent compound and decade of development. This classification is not clinically useful and should be abandoned. 90 Patients sometimes prefer a pill that they used previously, and if no contraindications exist and the cost is acceptable to the patient, it is reasonable to prescribe it ( Figure 1 and Figure 2 ).

Combined hormonal contraceptives can be dosed in a cyclic or continuous fashion. Originally, birth control pills were dosed with 21 days of active drug and a 7-day placebo week to trigger a monthly withdrawal bleed, meant to mimic the natural menstrual cycle. However, many women prefer less frequent withdrawal bleeds. 91 Some women report significant adverse effects 92 during this placebo week, such as migraine, bloating, and pelvic pain, and extended use provides an easy way to manage or eliminate these problems. 61 During the placebo week, there is less suppression of the HPO axis. 93 - 95 For these reasons, many newer contraceptive pills have shorter (eg, 4-day) placebo periods. Further, most monophasic combined hormonal contraceptives can be used as extended use (fewer withdrawal bleeds) by having a 4-day placebo period quarterly or continuously (no withdrawal bleed) by eliminating the placebo altogether. Extended and continuous use are associated with improved typical use efficacy, likely because greater overall HPO axis suppression is achieved, which may offset lapses in user adherence. 96 A new vaginal ring (segesterone acetate/ethinyl estradiol vaginal system) is also available, which is prescribed for 1 year, with the patient removing the ring each month for 7 days. 97

This review has several limitations. First, relatively few randomized clinical trials that directly compared contraceptive methods were available. Therefore, contraceptive methods are typically evaluated by their individual efficacy (pregnancies per person-cycles) and not typically by their relative effectiveness compared with another method. Second, the quality of summarized evidence was not evaluated. Third, some aspects of contraception, such as counseling, noncontraceptive health benefits, ongoing contraceptive innovations, and the effect of cultural values, and patient preferences were not covered in this review.

Oral contraceptive pills are the most commonly used reversible contraceptives, IUDs and subdermal implants have the highest effectiveness, and progestin-only and nonhormonal methods have the lowest risks. Optimal contraceptive selection incorporates patient values and preferences.

Corresponding Author: Stephanie Teal, MD, MPH, Department of OB/GYN, University Hospitals Medical Center and Case Western Reserve University, 11100 Euclid Ave, MAC-5304 Cleveland, OH 44106 ( [email protected] ).

Accepted for Publication: November 10, 2021.

Author Contributions: Drs Teal and Edelman had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design : Both authors.

Acquisition, analysis, or interpretation of data : Both authors.

Drafting of the manuscript : Both authors.

Critical revision of the manuscript for important intellectual content : Edelman.

Administrative, technical, or material support : Both authors.

Supervision : Both authors.

Conflict of Interest Disclosures: Dr Teal reported receiving grants from Merck & Co, Bayer Healthcare, Sebela, and Medicines360, and personal fees from Merck & Co and Bayer Healthcare outside the submitted work. Dr Edelman reported receiving grants from Merck, research funds from HRA Pharma, and royalties from UpToDate outside the submitted work.

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• 16 December 2020

Better birth control

• Elizabeth Svoboda 0

Elizabeth Svoboda is a science writer in San Jose, California.

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By the time she was 30, Terra had tried a wide range of options to stop her getting pregnant, but she couldn’t find one that suited her. “I never really felt like any of the available options were a great fit,” says Terra, a clinical psychologist from San Diego, California. “I wanted something that would put me in control, that was hormone-free and effective.”

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Nature 588 , S166-S167 (2020)

doi: https://doi.org/10.1038/d41586-020-03532-6

This article is part of Nature Outlook: Reproductive health , an editorially independent supplement produced with the financial support of third parties. About this content .

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Exploring Readiness for Birth Control in Improving Women Health Status: Factors Influencing the Adoption of Modern Contraceptives Methods for Family Planning Practices

Adnan muhammad shah.

1 Department of Computing Engineering, Gachon University, Seoul 13120, Korea; [email protected]

2 Department of Management Sciences, Shaheed Zulfikar Ali Bhutto Institute of Science and Technology, Islamabad 44320, Pakistan

3 Charles E. Schmidt College of Science, Florida Atlantic University, Boca Raton, FL 33431, USA

KangYoon Lee

Javaria nisa mir.

4 Faculty of Management Science, Riphah International University, Rawalpindi 46000, Pakistan; moc.liamg@110rimairevaj

Associated Data

The data used to support the findings of this study are available from the corresponding author upon request.

Background: Pakistan is the world’s sixth most populated country, with a population of approximately 208 million people. Despite this, just 25% of legitimate couples say they have used modern contraceptive methods. A large body of literature has indicated that sexual satisfaction is a complex and multifaceted concept, since it involves physical and cultural components. The purpose of this study is to investigate the impact of influencing factors in terms of contraceptive self-efficacy (CSE), contraceptive knowledge, and spousal communication on the adoption of modern contraceptive methods for family planning (FP) under the moderating role of perceived barriers. Methods: Data were collected using an adopted questionnaire issued to married women of reproductive age belonging to the Rawalpindi and Neelum Valley regions in Pakistan. The sample consisted of 250 married women of reproductive age. SPSS was used to analyze the respondents’ feedback. Results: The findings draw public attention towards CSE, contraceptive knowledge, and spousal communication, because these factors can increase the usage of modern methods for FP among couples, leading to a reduction in unwanted pregnancies and associated risks. Regarding the significant moderation effect of perceived barriers, if individuals (women) are highly motivated (CSE) to overcome perceived barriers by convincing their husbands to use contraceptives, the probability to adopt modern contraceptive methods for FP practices is increased. Conclusions: Policymakers should formulate strategies for the involvement of males by designing male-oriented FP program interventions and incorporating male FP workers to reduce communication barriers between couples. Future research should address several other important variables, such as the desire for additional child, myths/misconceptions, fear of side effects, and partner/friend discouragement, which also affect the adoption of modern contraceptive methods for FP practices.

1. Background

Pakistan is the world’s sixth most populated country, with a population of 208 million people at the time of writing [ 1 ]. The Pakistani government is concerned about population growth because it is related to economic and social consequences of unrestrained expansion [ 2 , 3 ]. Failure to control the rate of reproduction and rapid population expansion has negative consequences for development indices such as education, poverty, and life expectancy, especially for mother and child health [ 4 ]. Beginning in the 1960s, the country became a pioneer in the field of family planning (FP) among developing countries. Fifty years later, the program is still struggling to increase the use of modern contraceptives. The current contraceptive prevalence rate in Pakistan is 34%, compared to 62% in India and 56% in Bangladesh [ 5 , 6 ]. For years, the low and stagnant prevalence of contraception in Pakistan has been a source of academic debate [ 7 ]. Much has been written about Pakistan’s sluggish adoption of modern contraception methods, highlighting cultural hurdles, inconsistent political support, and service delivery failures [ 7 , 8 ]. The majority of the research has focused on service delivery problems, with the assumption that increasing contraceptive provision would improve contraceptive use [ 8 , 9 , 10 , 11 ].

The gradual increase in contraceptive rates in Pakistan compared to other nations in the region has been a hotly debated topic among demographers and other academics, with many speculating that inconsistencies in political support and a lackluster FP policy are to blame [ 11 , 12 ]. Researchers recommend that communication between couples should be encouraged because it increases the adoption of FP practices [ 13 , 14 , 15 ]. A recent study indicated that there is a need for modern contraceptive prevalence in Pakistan, which requires an increased uptake of contraceptives (National Institute of Population Studies (NIPS)) [ 16 ]. Pakistan has been facing the issue of FP for decades [ 17 ]. About 17% of married women in Pakistan have modern contraceptive prevalence for FP, and this rate is higher among rural areas. The demand for FP has reduced over the last 5 years, currently at 52% whilst it was 55% in 2012–2013. Pakistan has a 34% contraceptive prevalence rate, and the use of modern contraceptive methods has not increased since 2013 [ 16 ]. The literature shows that knowledge on contraceptives has profound effects on the FP practices [ 18 ]. Due to a lack of appropriate knowledge about contraceptive methods, women cannot get desired results [ 19 ].

Women’s self-efficacy and knowledge about the appropriate use and the side effects of contraceptive methods, a couple’s communication, and combined decisions are positive predictors of contraceptive use [ 20 ]. Women’s education and power to make decisions are significantly associated with the use of contraceptives [ 21 ]. Previous literature has indicated low contraceptive use in Pakistan, and there is an urgent need to explore factors which can help to improve FP practices and modern contraceptive prevalence necessary for FP practices [ 22 ]. Contraceptive self-efficacy (CSE), contraceptive knowledge, and spousal communication are found to be associated with FP practices [ 23 ]. Self-efficacy theory suggests that an individual’s belief in his own competence to perfectly perform any behavior is affected by several moderators and barriers, either personal or social [ 24 ]. Therefore, researchers have suggested that while assessing self-efficacy, the impact of perceived barriers on health behavior estimation must be examined [ 25 ]. Researchers have also reported several reasons for why improving contraceptive knowledge might improve contraceptive use [ 26 ]. Spousal communication is the determinant of FP practices, but there is need to assess this connection in the context of developing countries [ 13 ]. Because a lack of communication and counselling is affecting couples’ and women’s decision-making ability regarding fertility preferences [ 14 ], the current study attempts to assess the impact of these variables on women’s perceptions regarding the adoption of modern contraceptive methods for FP practices.

Numerous economists and researchers continue to doubt Pakistan’s ability to significantly boost the adoption of modern FP practices because of religious norms, social liberalism, and preferences for large family systems. Therefore, several gaps are observed in the policies and structure of programs related to FP practices in Pakistan [ 8 , 11 ] and other developing regions [ 27 , 28 ]. The unavailability of contraceptives, especially in rural areas, users’ dissatisfaction, low service quality, lack of proper guidance concerning the methods selected, religious factors, and a lack of knowledge, funding, and collaboration between public and private sector facilities providing FP services have been quoted as barriers that cause a low prevalence of contraceptive measures [ 10 , 17 ]. Since the context of this study is Pakistan, it is worth noting that FP in Pakistan is entirely female-oriented [ 29 ]. Programs that target only a single sex tend to fail to achieve its targets [ 13 ]. Therefore, all these issues need to be investigated, because they are affecting population control activities in the country. The theoretical foundation of this study is based on a combined health belief model, social cognitive theory, and the theory of planned behavior. In this regard, this study attempts to examine different predictors in the adoption of modern contraceptive methods for FP practices. This study will provide a thorough understanding of these factors, which will be helpful for the control of fertility.

The current study aims to explore the impact of spousal communication, contraceptive knowledge, and CSE on the adoption of modern contraceptive methods for FP practices in a developing country context, such as Pakistan. In addition, the moderating role of perceived barriers is, for the first time, theorized and tested to determine the relationship between contraceptive knowledge, spousal communication, CSE, and the adoption of modern contraceptive methods for FP practices. The findings of the current study would be helpful for policymakers in implementing and revising policies to further improve FP programs.

The rest of the sections in the current study are arranged as follows: Section 2 presents a literature review and hypotheses; Section 3 covers the proposed methodology, including sample and data collection, the measurement of variables, common method bias, and control variables; Section 4 explains the data analysis and results; finally, Section 5 discusses the results of the study, sheds light on practical implications, and recommends a direction for future research.

2. Literature Review

2.1. contraceptive self-efficacy (cse) and family planning (fp) practices.

Levinson, as cited in [ 30 ], defined CSE as “it is the strength of a young woman’s conviction that she should and could exercise control within sexual and contraceptive situations to prevent an unintended pregnancy, if that is what she desires” (p. 9). Following the self-efficacy theory, the concept of CSE was developed to measure women’s self-efficacy and its impact on their reproductive health. The extant literature indicates that women with higher self-efficacy are more independent in the selection and practice of modern contraceptive methods [ 31 , 32 ]. CSE is important because it stimulates individual behavior related to the use of modern contraceptives, therefore helping to prevent major public health issues by prompting the use of modern contraceptives [ 31 ]. Contraceptive acceptance is higher among females with higher CSE [ 33 , 34 , 35 ]. CSE enables women to manage all resistance related to FP practices [ 25 ]. Findings from previous research also reveal that CSE increases contraceptive adherence [ 20 ]. The above explanations suggest that CSE is a strong predictor of the use of modern contraceptive for FP practices. Therefore, it can be hypothesized that:

Contraceptive self-efficacy has a positive impact on the adoption of modern contraceptive methods for FP practices .

2.2. Contraceptive Knowledge and Family Planning (FP) Practices

Contraceptive knowledge was defined by Nsubuga et al. [ 36 ] as “the state of awareness of contraceptive methods, any specific types and the source of contraceptive”. Contraceptive knowledge enables women to easily access FP services [ 37 ]. It is reported that counselling increases contraceptive awareness, which modifies people’s attitudes towards the use of contraceptives [ 38 ]. Efficient contraceptive knowledge helps in changing people’s perceptions and decisions about FP [ 39 ]. Researchers have also found that educated women are more aware of contraceptive methods and FP practices, which ultimately increases the use of contraceptives among females [ 40 ]. It is also reported that females with good contraceptive knowledge practiced different methods effectively [ 41 ]. In contrast, individuals with a lack of contraceptive knowledge will discontinue contraceptive use due to its side effects or method failures [ 42 ]. According to a recent survey, 3/4th of the overall urban population is aware of FP practices, but a low level of awareness among rural population was reported [ 16 ]. Well-aware and knowledgeable individuals regarding different contraceptive methods have a tendency to solve different FP issues [ 43 , 44 , 45 ], such as intercourse and the method not changing the woman’s menstrual periods [ 46 ], intrauterine device and implant [ 47 ], and female sterilization [ 48 ].

Contraceptive knowledge in terms of awareness about the available contraceptive methods helps people in choosing the best and effective contraceptives practices, and also changes people’s fertility preferences [ 49 ]. It has been noted that people who are aware of implants and breastfeeding as contraceptive methods were more interested in the adoption of modern contraceptive methods for FP practices [ 50 ]. Studies in the context of a developing country, such as Pakistan, highlighted the gap between contraceptive knowledge and FP practice [ 17 , 51 ]. This gap is because of a lack of knowledge about the benefits and availability, as well as misinformation, of modern contraceptive methods for FP practices. Major sources delivering contraceptive knowledge include healthcare centers, friends, family, and media [ 52 ]. Therefore, based on the available literature, it can be hypothesized that:

Contraceptive knowledge has a positive impact on the adoption of modern contraceptive methods for FP practices.

2.3. Spousal Communication and Family Planning (FP) Practices

Backman, as cited in [ 53 ], stated that “spousal communication in the marital dyad is generally defined as the frequency of discussion between spouses, as reported by one or both partners” (p. 5). Communication between spouses plays an important role in the continuous adoption of modern contraceptive methods for FP practices. Partner communication appeared as a topic of interest regarding FP practices. In this regard, researchers found a positive association between spousal communication and FP practices [ 54 , 55 , 56 ]. Another study reported husbands as key decision makers for getting access to health and FP services. A husband’s education level is significantly associated with the current use of contraceptives. The location of service providers, the quality of services, women’s age, and financial status also determine the use of contraceptives [ 4 ].

FALAH (Family Advancement for Life and Health) is already working on male involvement in FP programs. An analysis of program outcomes found that engaging Pakistani men in FP practices to support and encourage their wives to use FP services and introducing male contraceptive methods can increase the utilization and acceptance of FP practices among the population [ 57 ]. Similarly, Khan et al. [ 58 ] stated that husband approval is a strong predictor of the use of contraceptives. Spousal communication helps in coping with psychological barriers and reduces emotional strains that discourage the use of contraceptives [ 59 ]. It helps couples in decision making concerning an appropriate family size, and enhances positive intentions towards modern contraceptive methods for FP practices. Thus, it can be hypothesized that:

Spousal communication has a positive impact on the adoption of modern contraceptive methods for FP practices.

2.4. Moderating Role of Perceived Barriers

Glasgow [ 60 ] defined perceived barriers as “A person’s estimation of the level of challenge of social, personal, environmental, and economic obstacles to a specified behavior” (p. 1). In the literature, the concept of perceived barriers has been extensively used with the health belief model (HBM). Perceived barriers have been used in many theories, including HBM, social cognitive theory, and social-ecological theory [ 60 ]. The integrated impact of multiple barriers hamper women from accessing reproductive health services. The restricted mobility of women by family [ 42 ] and a lack of communication between couples are factors that hamper women from using contraceptives [ 61 ]. Additionally, barriers restrain women’s ability to practice contraceptive methods. Most of the time, women that desire to limit their fertility by using contraceptives are influenced by religious and cultural hindrances [ 11 , 62 ]. They have to face great resistance from social barriers comparative to financial issues [ 63 , 64 ].

Women’s perceptions about contraceptive use, fear of their husbands’ negative response, and FP practices are perceived as an unacceptable act by society; therefore, culture limits the use of contraceptives among women [ 65 ]. Another study conducted by researchers in Pakistan declared that reasons for not using contraceptives include a desire for a baby boy (19%), fear of a health risk (29%), and lack of partner support and consideration of them as un-Islamic (14%); similar findings were found in other studies [ 66 , 67 ]. Interpersonal violence [ 68 ], cost, shyness, desire for a baby boy and a large family size [ 69 ], fear of sin, sterility [ 70 ], misinterpretation, husband and in-laws disapproval, prevailing myths, and social norms are all factors that contribute to the low intention of adopting of FP practices [ 66 , 71 ].

Fear of privacy breach, stigmatization, and FP service providers’ attitudes negatively affect the adoption of modern FP practices among women, despite them having knowledge about contraceptive use [ 72 , 73 ]. Spousal communication increases FP practices, but in-laws’ pressure, low parity, and administrative issues weaken this relationship [ 74 ]. Men’s disinterest and lack of knowledge about contraceptives, female financially dependency, and physical violence discourage women to communicate with their husbands about FP practices, which ultimately causes the low prevalence or lack of use of contraceptive methods [ 75 ]. Despite having information about several available FP methods, a low use of contraceptives has been noted among couples of rural areas due to misconceptions about risks associated with contraceptive methods [ 76 ]. Family environments also define women’s behavior towards FP practices [ 77 ]. A woman’s autonomy to make decisions about any aspect of her life is strongly influenced by the stratified family structure [ 78 ]. All these barriers contribute towards modern contraceptive prevalence for FP practices, in which women do not want to conceive for a period of time but still do not use any contraceptives [ 79 ]. Based on the above literature, it is argued whether perceived barriers act as moderator in the relationship between CSE, contraceptive knowledge, spousal communication, and FP practices or not. Therefore, it can be hypothesized that:

Perceived barriers moderate the relationship between contraceptive self-efficacy and the adoption of modern contraceptive methods for FP practices.

Perceived barriers moderate the relationship between contraceptive knowledge and the adoption of modern contraceptive methods for FP practices.

Perceived barriers moderate the relationship between spousal communication and the adoption of modern contraceptive methods for FP practices .

The research model of the study is presented in Figure 1 .

Research model.

3. Methodology

3.1. sample and data collection.

Women of reproductive age are the main target of FP practices in Pakistan due to higher needs for the use of contraceptives at this age. The adoption of modern contraceptive methods for FP is a key variable in current research. Using a convenience sampling technique, data were collected from married women of reproductive age from the Rawalpindi and Neelum Valley regions in Pakistan through distributed questionnaires. Convenience sampling has the advantages of being inexpensive, efficient, and easy to use. We selected the aforementioned sampling locations because both these regions are highly prevalent in terms of FP practices. Additionally, the travel restrictions implemented during the COVID-19 outbreak made it difficult for the authors to visit other areas for data collection. We decided to collect data using both self-administered questionnaires and social circles from these areas to distribute our questionnaire to the relevant samples. A cover letter was attached, declaring the purpose of the research and asking participants at the time they join the study for relevant and historical information on spousal communication and decision making regarding FP practices. A screening question was also placed at the beginning of the survey to clearly ask whether respondents belonged to these regions and they knew the contraceptive methods used in FP practices. Confidentiality, anonymity, and voluntary participation were also ensured.

A total number of 340 questionnaires were distributed. The authors believe that the sampling size was appropriate due to the COVID-19 restrictions and respondents’ hesitation to respond to specific questions because of cultural and religious beliefs [ 11 ]. Out of the 292 questionnaires that were returned 42 were not useable, making the valid response rate 73.5%. The contraceptive prevalence rate in our sample was 41.28%.

As shown in Table 1 , the majority of the women participants were literate (86.8%), most were non-working (63.6%), the majority of the women were in the age range of 24 to 35 years (78.3%), and the majority of the women got married in the age range of 18–25 years (72%). Most of the participants were residents of a rural area (70%), and most were Muslim (95.6%). The majority of the participants’ husbands were literate (95.2%) and working (97.2%). Of the respondents, 48% of them had a maximum of two–three children and (25%) had four or more children. Of the women, 92% of them reported having a good health status and 72.4% reported that their husbands were the head of the household. Of the respondents, 62.3% responded that their husbands were highly involvement in decision making regarding pregnancy, while 64.8% responded that they have spousal communication regarding FP and birth spacing.

Socio-demographic characteristics of respondents.

3.2. Measurements

All the study variables were measured on a 5-point Likert scale. All constructs were measured on a Likert scale ranging from strongly disagree = 1 to strongly agree = 5.

Constructs such as contraceptive self-efficacy (CSE) were measured using a 7-item scale developed by Prata et al. [ 80 ]. One sample item which was measured was “I can use a modern contraceptive method to prevent pregnancy”. Contraceptive knowledge (CK) was measured by using a 7-item scale developed by Lincoln et al. [ 81 ]. One sample item which was measured was “I am aware that health education is important for women who want to use contraception”. Spousal communication (SC) was measured using a 5-item scale developed by Wegs et al. [ 82 ]. One sample item which was measured was “I and my spouse discuss things that happened during the day”. Modern FP practices were measured using a 7-item scale developed by Lincoln, Mohammadnezhad, and Khan [ 81 ]. One sample item which was measured was “I often use one of the contraceptives to prevent unplanned pregnancy”. Perceived barriers (PB) were measured using a 14-item scale developed by Sen et al. [ 83 ]. One sample item which was measured was “Contraceptive measures are too expensive for me”. The details of all constructs and their corresponding items are presented in Appendix A , Table A1 . According to the criteria defined by Fornell and Larcker [ 84 ], the composite reliability values for all constructs were above the threshold (i.e., 0.70).

3.3. Common Method Bias

A common bias test was performed by taking into account Harman’s single factor [ 85 ]. Five constructs with their corresponding non-removed items were tested using an exploratory factor analysis by Harman’s single-factor test and analyzed with an unrotated factor solution. It was shown that there is no question about the common method bias in the current research data due to no emerging factor being reported, and 41.451% (less than 50%) variance was documented for the first factor, as suggested by Podsakoff, MacKenzie, Lee, and Podsakoff [ 85 ].

3.4. Control Variables

A one-way ANOVA was performed to control the variation in the adoption of modern contraceptive methods for FP practices on the basis of demographic variables used in the study. Results obtained from one-way ANOVA (see Table 2 ) indicated no significant differences in the adoption of contraceptive methods for FP practices (dependent variable) across qualification (F = 0.880, p > 0.05), profession (F = 3.371, p > 0.05), age at time of marriage (F = 2.881, p > 0.05), religion (F = 1.495, p > 0.05), health status (F = 1.267, p > 0.05), husband’s qualification (F = 1.496, p > 0.05), husband’s profession (F = 0.897, p > 0.05), and head of household (F = 0.399, p > 0.05).

One-way ANOVA.

At the same time, the one-way ANOVA indicated significant differences in FP across region (F = 19.089, p < 0.05), area of residence (F = 19.089, p < 0.05), current age (F = 2.682, p < 0.05), and number of children (F = 7.984, p < 0.05). Subsequently, factors identified as significant were entered as control variables in step 1 of a regression analysis for a single dependent variable.

Means, standard deviations, scale reliabilities ( bold diagonal entries ) , and correlation matrices are presented in Table 3 . Reliabilities for all constructs were greater than the cutoff value (i.e., α ≥ 0.7), which indicates acceptable reliability [ 86 ]. The results also revealed that all the absolute values of the correlation coefficients and the VIF statistics for each individual variable are less than 0.5 and 10, respectively [ 86 ]. Hence, multicollinearity is not a serious problem in the study, and the results are reliable. Table 3 also indicates that CSE is significantly positively correlated with modern FP practices (r = 0.48, p < 0.01) providing support for proposed hypothesis 1. Contraceptive knowledge is significantly positively correlated with modern FP practices (r = 0.34, p < 0.01), which provides support for proposed hypothesis 2. Modern FP practices are significantly positively correlated with spousal communication (r = 0.22, p < 0.01), which provides support for proposed hypothesis 3. Perceived barriers are not correlated with modern FP practices (r = 0.092, p = ns). Control variables, such as area of residence, region, current age, and number of children are positively correlated with modern FP practices.

Means, standard deviations, correlations, and reliabilities.

Notes: n = 250; alpha reliabilities are given in parentheses. p < 0.05. S.D = standard deviation, CSE = contraceptive self-efficacy, CK = contraceptive knowledge, SC = spousal communication, PB = perceived barriers, Qual = qualification, Prof. = profession, AoR = area of residence, Reg. = region, CA = current age, ATM = age at time of marriage, Relig. = religion, HQ = husband’s qualification, HP = husband’s profession, NC = No. of children, HS = health status, and HH = head of household. **, correlation is significant at the 0.01 level; *, correlation is significant at the 0.05 level. ns = correlation is not significant.

A multiple regression analysis was run to check the relationship between variables in the proposed model of this study. Table 4 shows the results of the regression analysis for the controls, direct effects, and moderating variable. The findings reveal that control variables, such as area of residence (β = 0.126, p < 0.01), region (β = 0.256, p < 0.05), current age (β = 0.325, p < 0.01), and number of children (β = 0.258, p < 0.05) significantly influence modern FP practices. The results show a significant positive impact of CSE on the adoption of modern contraceptive methods for FP practices (β = 0.551, p < 0.001). Thus, hypothesis 1 is accepted. The regression analysis shows that there is a significant positive impact of contraceptive knowledge on the adoption of modern contraceptive methods for FP practices as (β = 0.226, p < 0.01); thus, hypothesis 2 is accepted. In addition, the results indicate that spousal communication has a significant positive impact on the adoption of modern contraceptive methods for FP practices as (β = 0.184, p < 0.01), thus leading towards the acceptance of hypothesis 3. Analysis shows that perceived barriers have no significant direct effect on the adoption of modern contraceptive methods for FP practices as (β = 0.049, p = ns).

Hierarchical moderated regression analysis.

Notes: ***, p < 0.001; **, p < 0.01; and *, p < 0.05. CSE = contraceptive self-efficacy, CK = contraceptive knowledge, SC = spousal communication, and PB = perceived barriers. ns = not significant.

Hypotheses 4, 5, and 6 were tested using moderated regression analysis. Where control variables were entered in step 1, independent and moderator variables were entered in step 2, and interaction terms were entered in step 3. Results show that in the third step after incorporating for interaction terms, such as contraceptive self-efficacy×perceived barriers, the results (β = 0.168, p < 0.05) lead to the rejection of hypothesis 4, that higher perceived barriers weaken the relationship between contraceptive self-efficacy and the adoption of modern contraceptive methods for FP practices in such a way that the relationship is weaker when the perceived barrier is high.

Result shows that FP practices in women with high CSE will be higher even in the presence of high perceived barriers. In addition, regression analysis shows that by incorporating interaction terms in the model for contraceptive knowledge×perceived barriers (β = −0.020, p = ns) and for spousal communication×perceived barriers (β = 0.037, p = ns) in the model, hypotheses 5 and 6 are not accepted. These results indicate that perceived barriers are not moderating the relationship between contraceptive knowledge and the adoption of modern contraceptive methods for FP practices or that between spousal communication and the adoption of modern contraceptive methods for FP practices.

The interaction effect in Figure 2 shows that the relationship between CSE and the adoption of modern FP practices was stronger in the presence of high perceived barriers (in dashed red line) than in the presence of low perceived barriers (in solid blue line); thus, hypothesis 4 is rejected.

Interactive effect of contraceptive self-efficacy and perceived barriers on FP practices. CSE = contraceptive self-efficacy; PB = perceived barriers.

5. Discussion

The purpose of this study was to investigate the causal effect of different factors (i.e., CSE, contraceptive knowledge, and spousal communication) that influence the adoption of modern contraceptive methods for FP practices. Additionally, the moderating role of perceived barriers was also examined in the relationships between aforementioned constructs [ 31 , 32 ]. The findings were in support of previous studies conducted by scholars [ 20 , 25 ], where similar findings were reported.

Contraceptive knowledge as awareness was found to have a significant positive impact on the adoption of modern contraceptive methods for FP practices. These findings were in line with previous studies findings [ 37 , 40 ]. This is because contraceptive knowledge among women encourages them to adopt modern methods for FP services and choose suitable method for practice. A good level of contraceptive knowledge improves the modern contraceptive prevalence. Contraceptive knowledge modifies people’s perceptions about FP practices [ 39 ]. Furthermore, the majority respondents were literate, so they valued contraceptive knowledge as an important factor for FP practices. Thus, it is quite logical to infer that the adoption of modern contraceptive methods for FP in Pakistan can be enhanced by increasing comprehensive knowledge about contraceptive measures among women.

Similarly, spousal communication also has a positive impact on the adoption of modern contraceptive methods for FP practices. Spousal communication is an effective way to involve males in FP practices and support women’s decisions about fertility preferences. Partner support and encouragement is a key determinant of FP practices [ 87 ]. The current findings were in line with previous studies [ 54 , 55 , 56 , 88 ]. As discussed in the literature, good spousal communication and encouragement by their partners allows women to make decisions about desired family size, usability, selection, and awareness of all available FP methods, which results in a reduction in contraceptive discontinuation and their low prevalence. This situation usually happens because of public dissatisfaction and a fear of opposition. Introducing male-oriented FP methods could help in increasing the uptake of FP practices by couples.

The results of moderated regression analysis show that the relationship between CSE and the adoption of modern contraceptive methods for FP practices is moderated by perceived barriers. Since the perceived barriers were used as moderators between the relationship of CSE and modern FP practices for the first time, the findings of the current study are supported by evidence from previous studies [ 20 , 25 , 61 ], where they declared that women with higher CSE are motivated and can convince men to use contraceptives. The adoption of any health behavior is dependent on individuals’ intentions to adopt that specific behavior. If an individual has strong intentions to practice or adopt a specific health behavior as well as the self-efficacy to overcome his/her perceived obstacles, the probability to adopt a specific health behavior increases [ 89 , 90 ]. As in the current study, participants reported higher CSE; therefore, the presence of barriers cannot reduce their intentions to practice modern FP methods.

The results of the interactive effect of perceived barriers and contraceptive knowledge show that perceived barriers do not moderate the relationship between contraceptive knowledge and the adoption of modern FP practices, which contradicts a proposed hypothesis. This result is in accordance with the common-sense model [ 91 ]. The model explains that human behavior is determined by the process of learning. Before adopting any health behavior, an individual assesses its pros and cons through cognition. For example, if individuals have to get treatment for a disease they will think about its cost, prognosis, and benefits, and then make decisions about action. Comprehensive knowledge about threats associated with health behavior reduces fear and leads to the adoption of that behavior [ 92 ]. As the participants of this study reported a higher level of contraceptive knowledge, it can thus be concluded, based on the previous literature, that high contraceptive knowledge among women helps them to make informed choices, overcome fears, and motivate them towards adopting modern FP practices.

The results of the interactive effect between perceived barriers and spousal communication were not significant, which shows that perceived barriers were not moderating the relationship between spousal communication and the adoption of modern FP practices. Since the literature shows that spousal communication about using contraceptives and involving the male partner in decision making about fertility preferences directly influences efforts for limiting fertility, they help women in overcoming perceived barriers as the fear of opposition is being shared by both partners [ 93 ]. Evidence from previous studies [ 94 , 95 ] also reveals that dynamics of spousal communication have a positive effect on contraceptive behavior; thus, these result are in line with the findings of the current study. Spousal discussion boosts modern FP use and consequently reduces fertility and maternal mortality rate.

5.1. Practical Implications

The findings provide several implications for practice. It is recommended that policymakers should incorporate modern contraceptive FP program models as a strategy to enhance the contraceptive prevalence rate. Special consideration should be given to spousal communication, and couples should be encouraged to discuss the adoption of modern contraceptive methods for FP practices. Awareness campaigns should be launched that highlight the benefits of spousal discussion about ideal family size, societal pressures, complications related to closely spaced deliveries, unsafe abortion, the risks of maternal and child mortality, malnutrition among children, and modern FP practices. Policymakers should also formulate policies for male involvement in modern FP programs across the country by introducing improved male-oriented methods and incorporating male FP workers to reduce communication barriers and shyness (as shown by a program that has been launched by FALAH in Pakistan and reported positive outcomes) [ 57 ]. FP program stakeholders should focus on promoting contraceptive knowledge among women to promote the adoption of modern contraceptive methods for FP practices.

Understanding different factors in the adoption of modern FP practices is necessary in formulating more suitable policies for public health [ 8 , 96 ]. As the use of FP is high in educated and urbanized people, there is a need to focus on slums and rural areas with a low literacy rate as well as how their perceptions about ideal family size change [ 88 ]. As the findings indicated that improving contraceptive knowledge leads towards FP practices, this study provides baseline information to policymakers towards the value of gaining comprehensive knowledge to increase the use of FP [ 97 ]. This study also draws public attention towards spousal discussion because it can increase the usage of modern methods for FP among couples, leading to a reduction in unwanted pregnancies and associated risks. In addition, our findings highlight the need for proper fund allocation as well as the provision of training and refresher courses for female health workers [ 98 ]. Furthermore, counselling intervention should be introduced to involve in-laws in programs to reduce barriers toward the adoption of modern methods for FP practices [ 99 , 100 ]. This study attempts to assist the Pakistani government in reaching its national development goals of enhancing maternal and reproductive health through the increased use of modern contraceptives.

5.2. Limitations and Directions for Future Research

This paper has several limitations. First, the findings of current study were predisposing to recall bias as data were self-reported by respondents rather than dyads, etc. Future studies should ensure that the way questions are worded does not influence the answers of participants due to the possible risk of recall bias. Second, as the majority of the respondents belonged to the Rawalpindi and Neelum Valley regions, the findings may not be generalizable due to the smaller sample size and convenience sampling technique using a specific targeted group, which lack external validity. Future studies should run the analysis using a larger dataset. Third, the current study is limited and not able to measure several other important variables (i.e., the desire for an additional child, myths/misconceptions, fear of side effects, and partner/friend discouragement) which also affect the use of contraceptives. Future researchers are required to conduct studies on the approval of modern FP practices by couples and their association with contraceptive knowledge and barriers in acquiring contraceptive knowledge. Fourth, since the current study employed a statistical method due to the authors’ limitations in using advanced statistical tools, future studies may use PLS-SEM as an advanced statistical tool, which seems much more appropriate, especially when analyzing possible moderation. Finally, for formulating comprehensive strategies about couple counselling to overcome the knowledge and practice gap and to dispel misconceptions about contraceptives, researchers should conduct qualitative studies on spousal communication and contraceptive knowledge.

6. Conclusions

To conclude, the empirical analysis supported three hypotheses proposed in this study. The results indicated that CSE, contraceptive knowledge, and spousal communication positively impact the adoption of modern contraceptive methods for FP practices. In particular, the higher CSE in women motivates them to adopt modern contraceptive methods for FP practices. It also encourages women to overcome all the barriers, which limit their access to FP services. CSE helps women to understand the importance of FP practices that are important in maintaining the gap between child births. It supports women in decision making about fertility preferences, which helps them to recover their health from previous pregnancies and provide better care to their children.

Constructs along with their corresponding items.

Contraceptive Methods (A): Pill, IUCD, condom, periodic abstinence, withdrawal, female sterilization, male sterilization, implants.

Author Contributions

Conceptualization, J.N.M.; methodology, J.N.M.; software, J.N.M.; validation, A.M.S. and K.L.; formal analysis, J.N.M.; investigation, J.N.M.; resources, A.M.S.; data curation, J.N.M. and A.M.S.; writing—original draft preparation, J.N.M. and A.M.S.; writing—review and editing, A.M.S.; visualization, K.L.; supervision, K.L.; project administration, K.L.; funding acquisition, K.L. All authors have read and agreed to the published version of the manuscript.

This research was supported by the MSIT (Ministry of Science and ICT), Korea, under the ITRC (Information Technology Research Center) support program (IITP-2021-2017-0-01630), and the work (No. 2020-0-01907, Development of Smart Signage Technology for Automatic Classification of Untact Examination and Patient Status Based on AI) was supervised by the IITP (Institute for Information and Communications Technology Promotion).

Institutional Review Board Statement

The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of the Faculty of Management Sciences, Riphah International University, Islamabad, Pakistan (FMS/RSL/ERC/107 on 11 August 2020).

Informed Consent Statement

Not applicable.

Data Availability Statement

Conflicts of interest.

The authors declare no conflict of interest.

Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Open Access

Peer-reviewed

Research Article

Women’s views about contraception requirements for biomedical research participation

Roles Data curation, Formal analysis, Investigation, Methodology, Project administration, Supervision, Writing – original draft, Writing – review & editing

Affiliation Center for Bioethics and Department of Social Medicine, University of North Carolina School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America

Roles Conceptualization, Funding acquisition, Methodology, Writing – original draft, Writing – review & editing

Affiliation Kennedy Institute for Ethics, Georgetown University, Washington, D.C., United States of America

Roles Methodology, Resources, Supervision, Writing – review & editing

Affiliation Department of Health Behavior, University of North Carolina Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America

Roles Formal analysis, Investigation, Methodology, Supervision, Writing – review & editing

Affiliation UNC Project Malawi, Lilongwe, Malawi

Roles Data curation, Formal analysis, Investigation, Project administration, Writing – original draft, Writing – review & editing

Roles Data curation, Formal analysis, Investigation, Project administration, Writing – review & editing

Affiliation Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland, United States of America

Roles Methodology, Resources, Writing – review & editing

Affiliation Division of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Johns Hopkins University, Baltimore, Maryland, United States of America

Affiliation Institute for Global Health and Infectious Diseases, University of North Carolina School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America

Roles Data curation, Methodology, Writing – review & editing

Affiliation Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America

Roles Conceptualization, Funding acquisition, Methodology, Supervision, Writing – original draft, Writing – review & editing

* E-mail: [email protected]

• Kristen A. Sullivan, 
• Margaret Olivia Little, 
• Nora E. Rosenberg, 
• Chifundo Zimba, 
• Elana Jaffe, 
• Sappho Gilbert, 
• Jenell S. Coleman, 
• Irving Hoffman, 
• Tiwonge Mtande, 

• Published: May 8, 2019
• https://doi.org/10.1371/journal.pone.0216332
• Reader Comments

12 Jun 2019: The PLOS ONE Staff (2019) Correction: Women's views about contraception requirements for biomedical research participation. PLOS ONE 14(6): e0218424. https://doi.org/10.1371/journal.pone.0218424 View correction

The scientific and ethical importance of including women of reproductive age in biomedical research is widely acknowledged. Concerns about preventing fetal exposure to research interventions have motivated requirements for contraception among reproductive aged women in biomedical studies–often irrespective of risks and benefits or a woman’s actual potential for pregnancy, raising important questions about when such requirements are appropriate. The perspectives of women themselves on these issues are largely unexplored. We conducted 140 interviews, 70 in the U.S. and 70 in Malawi, with women either living with or at-risk for HIV, exploring their views about the practice of requiring contraception in clinical trials. A majority of women interviewed from both countries indicated overall support for the practice, with seven themes characterizing advantages and disadvantages raised: reproductive control, health effects, prevention of fetal harm, burden on women, deferral to authority, autonomy regarding enrollment and birth control method, and relationship concerns. While women in the US frequently raised prevention of fetal harm as a key advantage, many other positives noted by women in both countries were related to contraception use in general, not specific to a trial context. With regard to disadvantages, U.S. women tended to focus on biomedical risks such as side effects and impact on fertility, whereas Malawian women focused on the social risks of contraception requirements, including violations of trust in marital relations and suspicions of potential infidelity. Given the potential benefits and burdens highlighted, contraception in research should be sensitive to actual fetal risk assessments; directed where justified at optimizing effective pregnancy prevention; responsive to women’s reproductive preferences; and made available as an ancillary benefit even where risk thresholds do not justify requirement–in order to facilitate trials that are both ethical and robustly oriented around the interests and lives of women who will participate in them.

Citation: Sullivan KA, Little MO, Rosenberg NE, Zimba C, Jaffe E, Gilbert S, et al. (2019) Women’s views about contraception requirements for biomedical research participation. PLoS ONE 14(5): e0216332. https://doi.org/10.1371/journal.pone.0216332

Editor: Rieke van der Graaf, University Medical Center Utrecht, NETHERLANDS

Received: December 4, 2018; Accepted: April 18, 2019; Published: May 8, 2019

Copyright: © 2019 Sullivan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: The minimal data set informing the findings is contained in the manuscript, included as participant quotations, attributed to pseudonyms, that support each theme. As this is a qualitative study with a population of women described geographically and by HIV status, making the full data set publicly available could potentially lead to the identification of participants. Our ethics approval was granted based on the strict confidentiality of the individuals consenting to participate. Requests for further data access, in accordance with restrictions to maintain participant confidentiality, should be directed to: UNC Office of Human Research Ethics, 720 Martin Luther King Jr. Blvd., Bldg # 385, Second Floor, CB 7097, Chapel Hill, NC 27599; Email: [email protected] .

Funding: This work was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health ( https://www.niaid.nih.gov/ ) under award number R01AI108368 [PI A Lyerly]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Introduction

The scientific and ethical importance of including women of reproductive age in biomedical research is now widely acknowledged. Sex-based differences in disease mechanisms, treatments and interventions require inclusion of women to generate evidence for the care of female patients [ 1 – 3 ]. However, concerns regarding potential harms to fetuses of women who are or may become pregnant during the course of a trial have historically restricted women’s participation across biomedical research. While such restrictions are justified in some circumstances, they are often applied without robust consideration of maternal and fetal risks and benefits or consequences of exclusion. As a result, there are significant gaps in the evidence base for women’s health, and individual women may be unjustly denied the prospect of direct benefit from participation in some studies [ 4 , 5 ]. Though the inclusion of women and their interests in biomedical research has increased in recent years, robust inclusion remains elusive, as marked by enduring concerns about justice and fair access to benefits of investments in advancing biomedical knowledge [ 6 ]. Additionally, fetal protection concerns have also motivated contraception requirements among biomedical studies that do enroll reproductive-aged women, raising important questions about the appropriateness of these widespread requirements.

One pressing question is when, and under what conditions, women of reproductive potential should be required to use contraception as a precondition for enrollment in biomedical research. On the one hand, requirements for effective contraception have been considered an important way to prevent fetal exposure in biomedical research [ 7 , 8 ] and ensure women’s access to research where study interventions have the potential to cause fetal harm [ 9 ]. On the other hand, requirements for contraceptive use often persist independently of a woman’s actual potential for pregnancy, or in the absence of a meaningful assessment of the risks and benefits [ 10 ]. Further, provisions in U.S. Food and Drug Administration (FDA) guidance for the conduct of research with women of reproductive potential allow deferral of certain reproductive toxicity studies if requirements for contraception are instituted [ 8 ]; this raises the possibility that contraception requirements may at times be less about reducing theoretical fetal risks, and more about minimizing research and development (R&D) timelines and costs. These issues have raised concerns about whether current patterns of contraceptive requirements disrespect women’s autonomy, or unduly impose the risks and burdens of contraceptives to research participants [ 11 , 12 ], and unfairly impede access to research carrying the prospect of direct benefit. Additionally, concerns have been raised that the widespread use of hormonal contraception in biomedical research has problematically restricted our understanding of variations in pharmacokinetics associated with normal or natural menstrual cycles occurring in the absence of synthetic hormones [ 10 ].

In order to address these important concerns, improved guidance regarding contraception requirements in biomedical research is needed. There are currently no harmonized international regulatory guidelines for such requirements [ 13 ]. The U.S. FDA has recommended that “women be counseled about reliable use of contraception or abstinence … [but does not] specify the type of contraception used because FDA believes decisions of that nature are best left to the woman in consultation with her health care provider” [ 7 ]. U.S. regulations governing research with human subjects are silent on the use of contraception [ 14 ], and the Council for International Organizations of Medical Sciences (CIOMS) Ethical Guidelines for Research emphasizes the importance of access to contraception for women of childbearing potential in clinical studies, but does not address the ethical complexities of contraception requirements [ 9 ]. Individual Institutional Review Boards (IRBs) generally develop institution-specific guidance, which can vary widely. Additionally, limited suggested guidance has appeared in the academic literature; the two proposals that have been published used the FDA’s now-retired, letter-based labeling categories, and differ on several key points, including when, if ever, investigators may require abstinence or the use of contraception as an inclusion criterion [ 11 , 15 ].

It is important that researchers and policy makers take account of the diverse array of perspectives of women as they shape evolving regulations and best practices to address pregnancy, fertility, and the role of contraception in clinical trials [ 16 ]. In recent years, research subjects’ views have been recognized as a critical component to adequate research ethics analysis and oversight [ 17 ]. Although potential participants may not be knowledgeable about historical, institutional, or other factors that bear on policy options, they may well be aware of other morally relevant considerations that policy makers and scholars might otherwise overlook, including the ways in which their own values and life context affect how they view clinical trials when contraception is required.

Yet women’s views are largely missing from the discussion about contraception in research. We could identify no studies that asked women their views about the advantages and disadvantages of contraception requirements in research contexts, and only two studies of trial participants’ opinions that touched on the subject. A qualitative study in Uganda explored male and female participants’ understanding of the informed consent process for required contraceptives and reasons for noncompliance with contraception requirements in trials. While all respondents described being advised to avoid pregnancy during trial participation, factors reported to be associated with pregnancy included the belief that the investigational product presented low fetal risk, a need for children, male partner unwillingess to use condoms, and side effects of contraception [ 18 ]. A small survey of US women queried willingness to participate in hypothetical trials of drugs to reduce breast cancer risk, and found that requirements for the use of specific contraceptives, as opposed to women’s own choice of birth control method, reduced women’s willingness to participate [ 19 ]. Thus, debates among IRB members, researchers, regulators and policymakers have proceeded in the face of little empirical information about the views and concerns of those potentially most affected by such policies.

To address this void, we elicited women’s views on contraception requirements as part of a larger qualitative study conducted by the Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) project [ 20 ]. Our study interviewed pregnant and recently pregnant women living with or at risk of HIV/AIDS, exploring their views about and experiences around clinical trial participation. The context of HIV/AIDS research is particularly relevant to the exploration of contraception requirements in clinical trials for three reasons. First, considerable research has been conducted with women living with or at risk for HIV/AIDS, and issues related to pregnancy and contraception have been a matter of debate [ 21 – 23 ]. Second, women living with or at risk for HIV/AIDS are disproportionately low-income and face a range of challenges regarding access and consent to research participation in health care settings; understanding particular challenges of low- and middle- income country (LMIC) contexts where HIV research is often conducted and to which findings will be most relevant is critical [ 18 , 24 – 26 ]. Third, given the international partnerships that characterize HIV/AIDS research, standard research practices need to be sensitive to implications they may have for critical research in international settings. We therefore conducted a study of pregnant women in both the US and in Malawi, a country with a high prevalence of HIV/AIDS and a robust research infrastructure.

The data for this analysis were collected as part of a larger project, PHASES, which aims to develop guidance for ethically acceptable research on HIV treatment and prevention during pregnancy. We conducted qualitative, in-depth interviews using a semi-structured guide, as described previously [ 20 ]. The data for this analysis, collected between August 2016 and April 2017, pertain to women’s opinions about common contraception requirements for women participating in clinical trials. Interviewers described the common practice in clinical trials of requiring women to use birth control in order to participate, highlighting that two forms of birth control are often mandated, and that male partner vasectomy may not count as a type of birth control [ 12 , 27 ]. If the woman does not agree to use birth control, then she cannot participate in the study, even if she does not currently have a sexual partner (see Box 1 ). The purpose of this approach was to surface participants’ initial reactions to this widespread requirement in biomedical research with women of reproductive potential, including their thoughts around when it would and wouldn’t be appropriate. Therefore, no potential justifications for the contraception requirement were provided to the participants. Interviewers asked women to discuss what they thought about this practice of requiring contraception with open-ended probing of advantages and disadvantages, asking them to reflect on requiring one versus two forms, as well as their overall opinion.

Box 1. Contraception requirement language used in interviews

“In some research studies, if a woman who is not pregnant wants to participate she must agree to use birth control (for example condoms, birth control pills, an IUD, an implant, or previously having her tubes tied). Many times she will be asked to use two forms of birth control (for example a condom plus an IUD) for extra protection. It may not count if her partner has had a vasectomy. If she does not agree to use birth control then she cannot participate in the study, even if she does not currently have a sexual partner.”

Written, informed consent was completed prior to the interview. Interviews in Malawi were conducted in Chichewa by one of two researchers who are native speakers; all U.S. interviews were conducted in English. Demographic questions were also completed. The research was approved by the Institutional Review Boards at the University of North Carolina at Chapel Hill and Johns Hopkins Bloomberg School of Public Health and the National Health Science Research Committee of Malawi.

Participants

One hundred and forty interviews were conducted with pregnant or recently pregnant women living with or at risk for HIV; 70 at sites affiliated with UNC Project Malawi in Lilongwe, Malawi, and 70 at U.S. clinics affiliated with the University of North Carolina in Chapel Hill, North Carolina or Johns Hopkins University in Baltimore, Maryland.

Eligibility criteria for participation included that the adult woman either be pregnant or recently pregnant (within 2 years). Nearly half of the Malawi sample (n = 33) were purposively selected for their previous participation or attempted enrollment in a HIV prevention or treatment study during pregnancy, all of which had some form of contraception requirements; these participants did not have to meet the eligibility criteria of currently being pregnant or recently pregnant. Reflecting the broader purposes of the PHASES project, the sample equally represented women living with HIV and those at-risk. At both study sites in the US, women at-risk for HIV were receiving health care and were recruited from obstetrics clinics in jurisdictions with elevated incidence of HIV or AIDS among adolescents and women aged 15 to 45 years.

The analytic approach was informed by thematic analysis [ 28 ], and described in detail elsewhere [ 20 ]. Interviews were recorded, transcribed verbatim, and translated as necessary. Coding was an iterative process using NVivo software, with initial codes developed a priori from the interview guide. As analysis progressed, new codes were added as needed, and data was re-coded as applicable. Emergent themes were identified from making comparisons within and across individuals utilizing data display matrices, and identifying thematically and conceptually related categories. These themes were: reproductive control, health effects, preventing fetal harm, burden on women, deferral to authority, autonomy to enroll and choice of birth control method, and relationship concerns. Quotations representing each of the themes were selected and are attributed by pseudonym, country of residence, age, HIV status, and race/ethnicity.

Participant characteristics

Participant demographics are presented in Table 1 . Participant age ranged from 18 to 50 (mean age Malawi = 29.4, U.S. = 29.8), with the largest proportion of women in both countries in the 25–34 year age group. Seventy percent (n = 49) of U.S. participants were Black/African-American, and all women in Malawi were black Africans. Twenty-three percent of U.S. women were college graduates or higher, and 20% of participants in Malawi completed secondary school or higher. Thirty-six percent of U.S. women and 90% of Malawian women were married. It is worth noting that the concept of marriage in Malawi is colloquially considered to be broader than the explicit legal definition, and includes cohabitating couples who typically raise children together. In both countries, the majority of participants identified as Christians (67% in the US, 89% in Malawi), and 50% of participants were HIV-positive (35 in U.S. and 35 in Malawi).

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https://doi.org/10.1371/journal.pone.0216332.t001

More than half of women in both the U.S. (60%) and Malawi (58%) indicated overall support for the practice of requiring contraception in clinical trials; about a fifth opposed the requirement, and the remainder–also about a fifth–were unsure or said it depends on the circumstances (see Table 2 ). Those who were unsure or said it depends often believed the requirements should be determined based on the potential risks of exposure to the study drug if pregnancy were to occur during the course of the trial. Others felt a requirement for one type of birth control was reasonable, whereas requiring two forms placed an unnecessary burden on the woman and/or couple. In addition to their overall assessment, participants discussed what they saw as advantages and disadvantages of the practice. Their responses diverged both within and across countries, with several emergent themes being specific to one country or the other, as described below and summarized in Table 3 . Many women, regardless of overall support for or opposition to a contraceptive requirement, articulated nuanced and multifaceted opinions, including the different contexts in which and reasons why they felt it to be appropriate or not.

https://doi.org/10.1371/journal.pone.0216332.t002

https://doi.org/10.1371/journal.pone.0216332.t003

Reasons supporting clinical trial contraception requirements

Women cited varied reasons for supporting contraception requirements, including increased reproductive control, health benefits, preventing fetal harm, a low perceived burden on the woman, the authority of the researchers to establish the rules, and that women are free to decide if they want to participate or not and to choose the form(s) of contraception they prefer.

Increased reproductive control.

Respondents commonly viewed contraception requirements as offering a benefit to participants by providing access to and support for birth control use, and therefore, protection from unintended or unwanted pregnancies. In many cases, this was expressed as general support for contraception use, not necessarily limited to the context of trial participation.

“(I think it is a) good rule, because … getting pregnant is a life changing situation. It could alter your life in so many ways. It has altered mine. And … it opens up a whole another can of worms. So if you’re using a contraceptive… to help prevent [pregnancy], yes. Because right now , you just—when the intimacy come, the fun of having sex comes, you’re not thinking about pregnancy. . . .” Jayla, U.S., 37 years, HIV negative, African American/Black “ I think the rule is good because sometimes you can say I am tired of being alone , but you do not have a husband and so you find a boyfriend… but you are not getting an injection or anything else . So once you have sex with someone , you fall pregnant immediately . So when you accept this rule , you avoid a lot and you do not get pregnant . ” Mary, Malawi, 26 years, HIV negative, Black African

Some U.S. participants also viewed the two forms of contraception as enhancing protection against pregnancy.

(E)specially for younger girls… Mainly because one birth control sometimes fails , like if someone is on the pill . I was on the pill and didn’t use condoms . I ended up pregnant when I was 16 , so I would consider that … ” Veronica, U.S., 31 years, HIV negative, white

Particularly in Malawi, where men commonly are the primary decision-makers around birth control use, some participants saw requiring contraception as promoting women’s interests. One woman described how, if the husband has given consent for his wife to participate in the study, the birth control requirement would grant her an opportunity to defer further childbearing that she might desire but otherwise not have outside the context of the study.

“ Since they have put family planning that is why it is good , because if you have agreed that you will join the study with your husband , and there are husbands who don’t want contraceptives… . you get opportunity of resting , so go and get contraceptives . ” Violet, Malawi, 31 years, HIV negative, Black African

Health benefits.

Participants in the US also commonly noted the benefit of two forms of birth control offering protection against sexually transmitted infections, especially when one form is a condom. These reasons were also not typically limited to the research context.

“(I)t’s more protection. Because one form will prevent you from getting pregnant, and another one will prevent you from getting any STD. Like if it’s a condom, it will prevent you from STD . If it’s the pill, it will only prevent you from getting pregnant.” Andrea, U.S., 32 years, HIV negative, Latina

Women in Malawi discussed that provision of contraception under such trial requirements had potential health benefits to women and their offspring resulting from desired birth spacing.

“ (L)et’s say you have a husband in the house , it means when you are using family planning you cannot get pregnant fast . Meaning you can have 2 or 3 years while your body is still fine and you are not pregnant . You also give a chance for the child who is little to grow well . That is the advantage . ” Ellen, Malawi, 26 years, HIV positive, Black African

Preventing fetal harm.

Protection from fetal harm was a reason in support of contraception requirements in trials that commonly emerged unprompted from women in the US.

“ Because I feel like they’re [researchers] looking out for the interest—obviously whatever they’re testing won’t be good for the baby . So if she knows that … she doesn’t want to have any kid , or not get pregnant within a certain timeframe , then I think it’s a good rule . ” Tiana, U.S., 36 years, HIV negative, Black/African American

Notably, only one participant in Malawi described preventing fetal harm as a benefit of the requirement.

“(I)f you get pregnant you can stop taking the medication… because it might cause certain problems for the baby… So it’s good not to get pregnant (participants should) use a family planning method , even tubal ligation…” Leoni, Malawi, 34 years, HIV negative, Black African

Some participants in the US believed contraception requirements should be sensitive to the possibility of risk to potential offspring, and are appropriate for studies where such risk is present, but should not be a blanket requirement.

“ Again , it all depends on what the study is and how it could affect a fetus if you were to get pregnant or not if you could harm it , kill it , whatever . It depends on the scenario and the type of study it is… If it’s one that’s potentially able to harm the fetus then , yes , it’s a good rule . ” Dominique, U.S., 34 years, HIV positive, white

A participant noted the desire of researchers to protect the pregnancy and the fetus, and also guard against liability for possibly causing harm.

“ I think that that is important because some medical interventions … could be potentially harmful for the pregnancy , and I think , too , the researchers want to protect the patient but they also want to protect the liability for themselves and wouldn't want to expose the patient to any sort of toxins to the pregnancy or any kind of medication that could be potentially harmful for the fetus . ” Jasmine, U.S., 32 years, HIV negative, multi-racial

Low incremental burden for some women.

Several women in the U.S. noted that a contraception requirement would not be a significant additional burden, as long as they already are using birth control.

“ I think if I was at a time in my life where I wasn't going to have kids at that point or I wasn't planning on getting pregnant , then I don't see how that rule would really impact it . I mean I would take birth control anyway , so for me it wouldn't impact me one way or the next . ” Sarah, U.S., 32 years, HIV negative, white “ That's not too bad…because if you get two forms like a condom and a shot or a condom and a pill then that's not bad at all , because even without the study you'd probably be taking that Depo shot or you're probably using those condoms… I would agree with that . ” Jodi, U.S., 26 years, HIV positive, African-American/Black

Deferral to authority.

Some women in both the US and Malawi noted what they perceived as the legitimate authority of the researchers to develop their own rules for participants in their studies and that the rules must be followed by participants.

“I feel like that's a good rule—because, you can't make the rules up yourself . If you want to be a part of the study, you have to follow the rules that they come up with. So if they say that you have to do this a certain way, made you do two…, then–that's what you need to do.”

Ayana, U.S., 22 years, HIV negative, African-American

“ (Y)ou just have to follow the rules . Because the rule has been put in place , you have to follow it . Whether your husband had vasectomy , you still have to use birth control…” Fredah, Malawi, 25 years, HIV negative, Black African

Autonomy to enroll and choice of birth control method.

Numerous respondents supported the practice of requiring contraception because participation in studies is optional, and potential participants would be informed of such a requirement, provided a choice of birth control method(s), and could decide to enroll or not.

“(A)s long as she’s educated on it … If it’s just too much, and that’s not a risk she wants to take, then she can always just say, ‘No, I can’t do the study.’ As I said , as long as she goes into it with eyes wide open, has all the options available, and can switch if there’s any problems, then I don’t see a problem with it.” Sabrina, U.S., 33, HIV positive, African-American/Black “ It is good because you accepted on your own that you will use birth control methods until the research ends . No one forced you , you accepted on your own . ” Yvonne, Malawi, 37 years, HIV positive, Black African “ This rule does not cause me any problems… . (Y)ou can just choose what you use and which method suits you . ” Fredah, Malawi, 25 years, HIV negative, Black African

Reasons for opposing clinical trial contraception requirements

Women also articulated varied reasons in opposition to contraception requirements, including reduced reproductive control, negative health effects of birth control, the undue burden compliance places on the woman, and in Malawi, concerns around the requirement straining the relationship with their partner.

Reduced reproductive control.

A common theme emerging from opposition to birth control requirements was the perceived effect of giving the researchers control over when a woman can get pregnant.

“ It’s not good because it requires you to use contraceptives even if you don’t want to . So it might be like they are forcing you to do family planning while you don’t want . ” Violet, Malawi, 20 years, HIV negative, Black African “ …I wouldn't want nobody to tell me when , how I can get pregnant . Things change , you know , every day . You might don't want a child today but you might meet the love of your life and he might want a child in the next six months , you know . So I would not want nobody to determine when I can start my family or expand my family , so for me , no , I would not agree to join something that tells me when I can have my child . ” Felicia US, 37 years old, HIV negative, African American/Black

Negative health effects.

Another central concern was the potential side effects of birth control, and the recognition that these effects vary between individuals, making it a more challenging requirement for some.

“ (E)veryone’s body reacts different to birth control , so the effects of the birth control may make it uncomfortable for the person . ” Chanise, U.S., 23 years, HIV negative, African American/Black “ There are some women who respond very badly to contraceptives . It may cause certain problems for them . So they are the people that need to be considered properly or exempted . ” Saliza, Malawi, 34 years, HIV positive, Black African

Some women in the US expressed worry that taking two forms of birth control may magnify the risk of side effects, including potentially reducing women’s long-term fertility, especially over a multi-year study.

“ (I)t also can be very harmful to your body , so if you eventually want to have children and you already doubled up on birth control , it might be very hard for you to actually have children in the future… Cause especially when you've been on birth control for so long… it would be really hard for you to get pregnant . ” Issa, U.S., 19 years, HIV negative, African American/Black

Undue burden on women.

Numerous participants noted that the contraception requirement was nonsensical for women who are not sexually active.

“ At least if you are getting an injection when you have a husband , it can be good . Because you will know that with the husband I have , it will make sense . But if you do not have a lover , you don’t have a husband and you should find yourself injecting , it is not good . How can one get pregnant… ? ” Chikondi, Malawi, 25 years, HIV positive, Black African “Well, if I don’t have a current sexual partner , then what would be the point of being on birth control? And if the birth control doesn’t have any bearings on the actual study, then why do I need it?” Robin, U.S., 37 years, HIV positive, African American/Black

Several women in the US challenged the requirement for two types of birth control, believing one should be sufficient, and felt that it placed an undue burden on women. Some of these participants cited the relative effectiveness of different forms of birth control, arguing the number of forms required should depend on if one is long-acting/highly efficacious or not.

“(Two types of birth control) is excessive… (W)ith the long acting birth control you don't really need two forms … If it's not a long acting birth control then I think yes , maybe you need a backup …” Jasmine, U.S., 32 years, HIV negative, multi-racial

Another participant described what she believed was a more fair and rational approach, and also how she would circumvent this requirement to participate in a trial.

“ I think that they should say you have to use a form of birth control that gives you X amount of protection and then they should give you different options and say if you want to have an IUD that’s fine … If they say it needs to be ninety-eight percent effective and you want to use condoms and that’s only ninety percent , then they say you need to do something else and here are your options but I don’t think it should be you have to use (two forms) . That’s just ridiculous… I would just tell them what they want to hear . I mean I would , I’m sure a lot of people would do that… So yeah , so I would lie … ” Wendy, U.S., 30 years, HIV negative, white

A few US women discussed that they are disinclined to take any medication, so that this requirement would create a barrier to their participation.

“ I like to do a lot of things… the natural way… I’m not really big into a lot of medication and… putting things into your body… So if you want me to take two types of birth control , I just think that’s a bit much . ” Wanda, U.S., 33 years, HIV positive, African American/Black

Relationship concerns.

Participants in Malawi raised concerns that the contraception requirement could potentially damage their marital relationships, especially if a woman was using birth control while her husband was away, causing suspicions of infidelity.

“ Your husband is away , and you are using contraceptives here ? Your husband is at liberty to speculate you were doing wrong things , … ‘Why were you using contraceptive while I was away ? ’ … This destroys marriages… . ” Sylvia, Malawi, HIV positive, 29 years old, Black African

Some women commented on the potential relationship problems that insisting on two forms of contraception could cause if the male partner has had a vasectomy, as it would imply the woman is being unfaithful.

“ So for someone whose husband had vasectomy , right , if the husband sees the contraceptive , he going to say you are doing it with other men . Yes , because your husband had vasectomy and I don’t have any other person to sleep with I don’t have anyone to impregnate me how am I supposed to use contraceptives ? That is not appropriate . ” Rhoda, Malawi, HIV negative, 33 years old, Black African

Another participant noted some men’s aversion to condoms, and that requiring two forms of birth control may lead to infidelity.

“ Some men don’t accept; they say I don’t want a condom… So let’s say he is your husband saying I don’t want a condom; it means you have given him a chance to go out with other women . ” Faye, Malawi, 31 years, HIV positive, Black African

Our study is the first cross-national qualitative study to our knowledge of women’s views about contraception requirements for biomedical research participation. Among 140 women in the U.S and Malawi, a majority offered overall support for contraception requirements, while some women were opposed and others were unsure. Seven themes characterized the identified advantages and disadvantages of research-related contraception requirements generally, several of which were country-specific (see Table 3 ). Not only do our findings expand the conversation beyond considerations generally raised in debates about contraception requirements, but they highlight the ways that context shapes women’s experience–as well as the ethics–of requiring contraception in a clinical trial.

Specifically, while the proportion of participants in favor of or against contraception requirements were similar across the two countries, the reasons offered were not. Particularly notable is the contrast between Malawian and U.S. participants in their characterization of the burdens of contraception requirements. U.S. women tended to focus on biomedical concerns such as side effects and impact on fertility, and questioned whether requiring two forms of birth control was medically justified. In contrast, Malawian women focused on the social risks of birth control requirements, which could be profound: while the use of a contraceptive could lead to violations of trust in marital relations and suspicions of potential infidelity, it could also serve as a leverage point for women’s reproductive control.

Respondents in the U.S. and Malawi were more similar in the ways that they characterized the benefits of contraception requirements, though important differences remained. Many of the positives noted were related to contraception use in general, and not specific to a trial context. Women in both countries noted that contraception requirements could enhance reproductive control by reducing unintended pregnancy. If contraception was meaningfully accessible and its use supported outside the context of a study, it would seem that requiring contraception use by research participants would not in fact increase reproductive control. But contraceptives are not necessarily easily accessible for women in either setting, and their socio-cultural contexts may not support contraceptive use. For example, in the U.S., there may be financial constraints for women without any health insurance or with health insurance that does not cover all contraception types [ 29 , 30 ]. In the Malawian context, there may be cultural constraints such as a presumption that use of contraceptives implies infidelity in marriage, or structural constraints such as transport barriers, long wait-times, and limited contraception options. In both contexts, then, a research participation requirement that mandates and supplies contraception can be both useful to and welcomed by women who do not desire pregnancy. In the Malawi context, for example, contraception requirements for trial participation were seen as facilitating birth spacing, which has important health benefits for women and children alike.

To the extent that a research requirement for contraception is welcomed by women whose use of contraception is otherwise constrained, some may question whether a requirement for and provision of contraception could represent undue inducement for some participants. While contraceptives may be an ancillary benefit for those who desire them, undue inducement pertains only when an offer has a distorting impact on a research participant’s ability to rationally weigh costs and benefits of participation [ 31 ]. Nothing respondents in our study said indicate such a distorting influence; and none offered that access to contraception itself would change their mind in favor of participation. Further, given the unfortunate constraints on contraception use for some women outside of a research context, the reasons participants offered in favor of access are entirely rational.

Whether in favor of or against contraception requirements, our data highlight the importance of considering how socioeconomic and cultural context–gender, race, socioeconomic status, cultural considerations–shape women’s views about contraception. In recent years, discussions of ethics and reproduction have increasingly employed what is known as a “reproductive justice” framework. As opposed to a “reproductive rights” framework, which tends to focus on rights of access to contraception and abortion, the reproductive justice framework takes a broader view and considers the myriad issues that affect women’s reproductive lives. Centrally, the framework recognizes women’s interests in having (as well as not having) children and being able to raise them in a safe, healthy environment [ 32 ]. The concept of justice thus extends beyond ensuring legal access to means to prevent or discontinue pregnancy to ensuring fair access to resources, non-discriminatory policies, and institutional structures that enable women to maintain control over their bodies and lives, and would press questions not just about fair access to contraceptives but the ethics of requiring that women use them [ 33 ]. Critically, the reproductive justice framework also considers how gender, race, and socioeconomic status shape access to and experiences of reproductive health care, including within clinical research [ 34 ]. In keeping with the reproductive justice framework, the differential concerns of Malawian and U.S. women reflect the important impact that cultural context may have on women’s views about and experiences of contraception requirements in clinical studies. In particular, in Malawian contexts, where society has been described as largely patriarchal [ 35 , 36 ], contraception requirements may be seen as a way for women to work around gender power differentials when contraception is desired; or as a burden that may engender conflict in marital relationships. A reproductive justice framework would attend to both sets of concerns as well as the ways in which cultural norms around gender shape the experience of the requirements–both in terms of creating opportunities for empowerment through contraceptive access and introducing risk for women who desire study participation. As such, a reproductive justice framework would potentially entail a shift away from an emphasis on required use, and toward approaches that support women’s informed choices about use or non-use of contraceptives, as well as access to desired contraceptives in research contexts.

For the research community, contraception in clinical trials is motivated by various factors, often in combination. These include a desire to protect the fetus from research risks, reduce costs and product development timelines, protect from liability due to pregnancy exposures in clinical trials, and maintain the “statistical integrity” of studies that can be compromised by high pregnancy rates associated with study withdrawal [ 22 , 37 ]. Some women in both the U.S. and Malawi felt that researchers–by virtue of their authority as researchers–should be able to impose contraception requirements. However, many respondents’ reasons for favoring contraception requirements included the benefits of contraception generally, rather than being solely motivated by a desire to protect their potential offspring. Also, from our Malawi respondents we learned that contraception requirements entail burdens for women that may not have been previously appreciated. While a range of external considerations such as sponsor liability are likely to inform decisions about contraception requirements, our findings suggest at least four ways in which such requirements could be more responsive to and respectful of research participants.

First, contraception requirements should be sensitive to actual fetal risk assessments. In studies involving women, contraception requirements have tended to be presumed to be justified–and necessary–even where fetal risk is uncertain. For instance, women of childbearing age may be required to use highly effective methods of birth control and pregnancy tests when participating in early phase trials before non-clinical reproductive toxicology studies have been conducted [ 8 ]. But there are many circumstances where contraception is required in which the risk of harm to offspring is extremely low and well-characterized. As some of our U.S. participants indicated, whether contraception requirements are justified under these conditions is, at best, questionable. Given the burdens made vivid by our study, it may be more appropriate and respectful of women’s interests to require that researchers justify any requirement for contraception–and not only in terms of the likelihood of harm of early fetal exposure to a drug or biologic but also in terms of the likelihood of incident pregnancy. Factors to be considered should include sexual activity and orientation of participants, the potential burdens of contraceptives both in terms of biomedical and social risks, and the likelihood that women of childbearing age will use the intervention in clinical contexts and become pregnant.

Second, wherever possible, researchers should strongly consider providing access to contraception, even where pregnancy-associated risks of research are minimal and contraception requirements are unwarranted. There is increasing recognition that researchers have responsibilities to provide needed medical care that is beyond the narrow purview of their research (ancillary care) [ 38 ]. Access to contraception is widely recognized as important to women’s health and empowerment, and global disparities in such access is a topic of ongoing concern [ 39 , 40 ]. Given that many of the benefits that women reported from contraception requirements were actually benefits of having access to contraception that might otherwise be challenging to obtain, ensuring access to contraception as a form of ancillary care should be considered in research planning and implementation.

Third, when contraception requirements are deemed appropriate, they should be directed at optimizing effective pregnancy prevention rather than a blunt approach of mandating “two forms” of contraception absent clear evidence of improved protection. Interestingly, where prevention of pregnancy is a priority, “clinical guidelines and national data” have indicated that “using one effective method [of contraception] correctly and consistently” is the best way to avoid pregnancy in clinical settings, and that providing choice over modality increases use [ 41 , 42 ]. There is no reason to believe that the research context would be different. Additionally, individual factors, including if a woman exclusively has sex with women, is abstinent, or infertile should be explored and integrated into assessing the appropriateness of the requirements. Incorporating evidence-based contraceptive counseling that is responsive to women’s needs and life circumstances, and allowing a range of contraceptive options, may serve a dual purpose of respecting women’s autonomy as well as reducing unintended pregnancies in research contexts, while also potentially increasing trial eligibility, recruitment, and retention.

Finally, our findings may have implications for understanding the high rates of contraceptive failure in clinical studies [ 37 , 43 , 44 ]. Research on the psychology of contraceptive use indicates that women’s efforts to avoid pregnancy are based on a “benefit:burden ratio” and that contraceptive use depends on a range of evolving factors, including positive and negative views about becoming pregnant as well as perceptions of and experiences with specific contraception methods [ 38 , 45 , 46 ]. We are not aware of any studies on the psychology of contraceptive use where contraception was required in clinical research. One observational study cited misconceptions and incorrect use as contributing to unintended pregnancies in trials [ 47 ]. Non-adherence to study requirements for contraception may be high where motivations regarding pregnancy are at odds with study requirements, there is ambivalence about contraceptive methods or use, and social contexts may weigh heavily on decisions about pregnancy and contraception. In addition to addressing high rates of contraceptive failure, it may be prudent to be more deliberate and reasoned about when contraception should be required, and consider whether offering more contraceptive choices in the context of studies could lead to a more robust evidence base that meets the needs of women across their reproductive lives.

Several considerations inform interpretation and generalizability of our results. Our qualitative methodology was intended to identify and explore women’s opinions on contraception requirements in order to surface themes and concrete considerations that policy makers should be cognizant of when determining regulations and best practices. It was not intended to measure the prevalence of such views among women, or to assess women’s views about their appropriateness in specific study contexts with varying levels of potential risks to the fetus, both of which may further inform future policies. Our sample is not representative of all women at risk for or living with HIV in the U.S. and Malawi, or women of reproductive potential more generally. Our results cannot be generalized to the population of women who might be eligible for research participation.

Our study has several limitations. The sample for this study included pregnant women, for whom the contraception requirement would not be immediately applicable. How pregnancy may affect women’s views of contraception requirements while participating in research remains unclear. Additionally, a more representative sample of reproductive-aged women at risk for or living with HIV may include different proportions of women who are infertile, who do not desire pregnancy, or who exclusively have female sex partners, characteristics which are likely to influence views on clinical trial contraception requirements.

Future qualitative research with a complementary sample of women of reproductive age who are neither pregnant nor recently pregnant would be useful to explore if substantive variations in views related to these considerations exist. Additionally, research using quantitative methodologies would be beneficial to more clearly delineate the prevalence of and potential associations within these views. Further, while this particular set of questions referenced research generally and did not specify a particular health condition, respondents were primed to respond to HIV-related research with interview questions that preceded this one; their answers may have been influenced by these prior references. We did not ask women to consider specific types of contraceptives, nor did we ask them to reflect on how level of or uncertainty about fetal risk, or other potential justifications for contraception requirements, would affect their views. All would be important topics of future study.

Requiring a woman to use contraception in any circumstance is ethically complicated. Yet in the context of biomedical research with women of childbearing age, contraception requirements have often been viewed as necessary to the ethical conduct of research–or an allowable option for minimizing R&D timelines and costs by delaying developmental toxicity studies. Our study highlights the ways in which contraception in the context of research may be viewed as either valuable or burdensome to women, depending on social context, and underscores the ethical complexity of contraception requirements in clinical research. These findings highlight considerations important to developing ethical guidance for the provision or requirement of contraceptives in the context of clinical trials, and to robustly orienting such trials around the interests and lives of the women who will participate in them.

Acknowledgments

The authors gratefully acknowledge the women who participated in these interviews and shared their time, views, and experiences. We very much appreciate Dr. Francis Martinson at UNC Project Malawi and Dr. Claire Farel at the UNC Infectious Disease Clinic, for their support of this work. Warm thanks are also extended to Bernadette Harley-Boon, Altricia Belk, Patrice Ross-Johns, and Krissa Pecunes at Johns Hopkins University, and Karen Dorman and Katherine Barley at UNC Chapel Hill for their assistance in navigating the clinics and the participant recruitment process.

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