David Hubacher

A definition of modern contraceptive methods.

Modern contraceptive methods were invented so couples could act on natural impulses and desires with diminished risks of pregnancy.Modern contraceptivemethods are technological advances designed to overcome biology. In this regard,modern methods must enable couples to have sexual intercourse at any mutually-desired time. The term modern contraceptive is rarely defined. Instead, organizations and individuals who use the term simply name contraceptives and approaches that fit into their perception of that label. Thus, researchers who measure levels of modern contraceptive prevalence often differ in how they categorize particular methods. For example, the United Nations Population Fund (UNFPA) and the Guttmacher Institute [1] name lactational amenorrhea as a traditional method, while the World Health Organization [2] and researchers with the Demographic and Health Surveys label it as a modern method [3]. These organizations differ on other classifications as well. The UNFPA places some types of periodic abstinence in the modern category while the United Nations Population Division labels all periodic abstinence techniques as traditional methods [4].

Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial

BACKGROUND: Measures of contraceptive effectiveness combine technology and user‐related factors. Observational studies show higher effectiveness of long‐acting reversible contraception compared with short‐acting reversible contraception. Women who choose long‐acting reversible contraception may differ in key ways from women who choose short‐acting reversible contraception, and it may be these differences that are responsible for the high effectiveness of long‐acting reversible contraception. Wider use of long‐acting reversible contraception is recommended, but scientific evidence of acceptability and successful use is lacking in a population that typically opts for short‐acting methods. OBJECTIVE: The objective of the study was to reduce bias in measuring contraceptive effectiveness and better isolate the independent role that long‐acting reversible contraception has in preventing unintended pregnancy relative to short‐acting reversible contraception. STUDY DESIGN: We conducted a partially randomized patient preference trial and recruited women aged 18–29 years who were seeking a short‐acting method (pills or injectable). Participants who agreed to randomization were assigned to 1 of 2 categories: long‐acting reversible contraception or short‐acting reversible contraception. Women who declined randomization but agreed to follow‐up in the observational cohort chose their preferred method. Under randomization, participants chose a specific method in the category and received it for free, whereas participants in the preference cohort paid for the contraception in their usual fashion. Participants were followed up prospectively to measure primary outcomes of method continuation and unintended pregnancy at 12 months. Kaplan‐Meier techniques were used to estimate method continuation probabilities. Intent‐to‐treat principles were applied after method initiation for comparing incidence of unintended pregnancy. We also measured acceptability in terms of level of happiness with the products. RESULTS: Of the 916 participants, 43% chose randomization and 57% chose the preference option. Complete loss to follow‐up at 12 months was <2%. The 12‐month method continuation probabilities were 63.3% (95% confidence interval, 58.9–67.3) (preference short‐acting reversible contraception), 53.0% (95% confidence interval, 45.7–59.8) (randomized short‐acting reversible contraception), and 77.8% (95% confidence interval, 71.0–83.2) (randomized long‐acting reversible contraception) (P < .001 in the primary comparison involving randomized groups). The 12‐month cumulative unintended pregnancy probabilities were 6.4% (95% confidence interval, 4.1–8.7) (preference short‐acting reversible contraception), 7.7% (95% confidence interval, 3.3–12.1) (randomized short‐acting reversible contraception), and 0.7% (95% confidence interval, 0.0–4.7) (randomized long‐acting reversible contraception) (P = .01 when comparing randomized groups). In the secondary comparisons involving only short‐acting reversible contraception users, the continuation probability was higher in the preference group compared with the randomized group (P = .04). However, the short‐acting reversible contraception randomized group and short‐acting reversible contraception preference group had statistically equivalent rates of unintended pregnancy (P = .77). Seventy‐eight percent of randomized long‐acting reversible contraception users were happy/neutral with their initial method, compared with 89% of randomized short‐acting reversible contraception users (P < .05). However, among method continuers at 12 months, all groups were equally happy/neutral (>90%). CONCLUSION: Even in a typical population of women who presented to initiate or continue short‐acting reversible contraception, long‐acting reversible contraception proved highly acceptable. One year after initiation, women randomized to long‐acting reversible contraception had high continuation rates and consequently experienced superior protection from unintended pregnancy compared with women using short‐acting reversible contraception; these findings are attributable to the initial technology and not underlying factors that often bias observational estimates of effectiveness. The similarly patterned experiences of the 2 short‐acting reversible contraception cohorts provide a bridge of generalizability between the randomized group and usual‐care preference group. Benefits of increased voluntary uptake of long‐acting reversible contraception may extend to wider populations than previously thought.

Extended use up to 5 years of the etonogestrel-releasing subdermal contraceptive implant: comparison to levonorgestrel-releasing subdermal implant

STUDY QUESTION Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? SUMMARY ANSWER The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. WHAT IS KNOWN ALREADY The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks. STUDY DESIGN SIZE, DURATION For the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan–Meier (K–M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes. PARTICIPANTS/MATERIALS, SETTING, METHODS The study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively. MAIN RESULTS AND THE ROLE OF CHANCE Over 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K–M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2–1.8] and 0.8 per 100 W-Y [95% CI: 0.2–2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p < 0.05). The median duration of the implant removal procedure was 64 seconds shorter for the one-rod ENG-implant (inter-quartile range (IQR) = 30.5, 117.5) compared to the two-rod LNG product (IQR = 77.0, 180.0). The 2-year rate for pregnancy in the IUD group compared with the two implant groups combined was 4.1 per 100 W-Y [95% CI: 2.5–6.5]. LIMITATIONS, REASONS FOR CAUTION Few women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few. WIDER IMPLICATIONS OF THE FINDINGS The results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the products capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal implant. The findings provide valuable information for policy makers, family planning programmers and clinicians that the ENG-releasing subdermal implant is still highly effective up to 5 years after insertion. Compared to previous efforts, our study population was geographically diverse and our study had the highest number of participants completing at least 5 years of use. TRIAL REGISTRATION The trial was registered as ISRCTN33378571. STUDY FUNDING/COMPETING INTEREST(S) The contraceptive devices and funds for conduct of the study were provided by the United Nations Development Programme/United Nations Population Fund/World Health Organization (WHO)/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), WHO. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. All stated authors have no conflict of interest, except Dr Hubacher who reported grants from United States Agency for International Development, during the conduct of the study; other from Advisory Boards (Teva, Bayer, OCON), outside the submitted work.

Rationale and enrollment results for a partially randomized patient preference trial to compare continuation rates of short-acting and long-acting reversible contraception☆☆☆

OBJECTIVES Most published contraceptive continuation rates have scientific limitations and cannot be compared; this is particularly true for dissimilar contraceptives. This study uses a new approach to determine if high continuation rates of long-acting reversible contraception (LARC) and protection from unintended pregnancy are observable in a population not self-selecting to use LARC. STUDY DESIGN We are conducting a partially randomized patient preference trial (PRPPT) to compare continuation rates of short-acting reversible contraception (SARC) and LARC. Only women seeking SARC were invited to participate. Participants chose to be in the preference cohort (self-selected method use) or opted to be randomized to SARC or LARC; only those in the randomized cohort received free product. We compared participant characteristics, reasons for not trying LARC previously and the contraceptive choices that were made. RESULTS We enrolled 917 eligible women; 57% chose to be in the preference cohort and 43% opted for the randomized trial. The preference and randomized cohorts were similar on most factors. However, the randomized cohort was more likely than the preference cohort to be uninsured (48% versus 36%, respectively) and to cite cost as a reason for not trying LARC previously (50% versus 10%) (p<.01 for both comparisons). In the preference cohort, fear of pain/injury/side effects/health risks were the predominant reasons (cited by over 25%) for not trying LARC previously (p<.01 in comparison to randomized cohort). CONCLUSIONS Enrollment was successful and the process created different cohorts to compare contraceptive continuation rates and unintended pregnancy in this ongoing trial. The choices participants made were associated with numerous factors; lack of insurance was associated with participation in the randomized trial. IMPLICATIONS This PRPPT will provide new estimates of contraceptive continuation rates, such that any benefits of LARC will be more easily attributable to the technology and not the user. Combined with measuring level of satisfaction with LARC, the results will help project the potential role and benefits of expanding voluntary use of LARC.

Uptake of the levonorgestrel intrauterine system among recent postpartum women in Kenya: factors associated with decision-making ☆

BACKGROUND The levonorgestrel intrauterine system (LNG IUS) may become more available in the public sector of resource-poor countries, but it is unclear what product features might be attractive to users and what factors will influence uptake. STUDY DESIGN We recruited 671 women in Kenya who were seeking contraception at 6-12 weeks postpartum and gave them an opportunity to try the LNG IUS. We asked why they did or did not choose it, relative to the alternative options. χ² tests of association were done to examine participant characteristics and decision-making associated with choice. RESULTS Participants chose the following methods: LNG IUS (16%), injectable (36%), subdermal implant (30%), progestin-only pills (15%) and copper intrauterine device (IUD) (3%). Reasons for not choosing the LNG IUS included fear of pain/injury/discomfort (34%), modesty issues regarding insertion (33%) and fear of hormonal/health side effects (31%). Nearly a third of LNG IUS acceptors said they would have chosen a short-acting method if the LNG IUS were not available, and only 21% would have chosen the copper IUD. CONCLUSIONS The LNG IUS could be an ideal method for increasing uptake of long-acting methods among recent postpartum women. Product attributes and comparisons to other contraceptive options are important factors in decision-making. Even among women comfortable with intrauterine contraception, great distinctions and preferences are apparent. Addressing specific misconceptions and fears with better information can help women make the best personal choices.

Sino-implant (II)® continuation and effect of concomitant tenofovir disoproxil fumarate-emtricitabine use on plasma levonorgestrel concentrations among women in Bondo, Kenya

OBJECTIVE The objective was to assess associations between tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) exposure and levonorgestrel (LNG) concentrations among Kenyan HIV prevention trial participants using Sino-implant (II) LNG implants for contraception. METHODS Women were offered implants among other contraceptive methods, were randomized to daily TDF-FTC or placebo, and followed monthly up to 56weeks. Associations between TDF-FTC exposure and mean LNG values were analyzed with linear mixed models. RESULTS Of 739 women, 29 (3.9%) received implants with no incident pregnancies and one discontinuation. Mean LNG concentrations over 56weeks among 28 women contributing data ranged between 214.0 and 659.8pg/mL with no significant difference between TDF-FTC and placebo arms or between variable levels of TDF-FTC adherence. CONCLUSION Concomitant TDF-FTC use was not associated with a significant change in plasma LNG concentrations among women using Sino-implant (II) in the first year of use.

The levonorgestrel intrauterine system: cohort study to assess satisfaction in a postpartum population in Kenya.

BACKGROUND The levonorgestrel intrauterine system (LNG IUS) may become the next long-acting contraceptive to be introduced in public sector programs of resource-poor countries. Whereas service provision for subdermal implants and intrauterine devices is growing, little is known about how the LNG IUS might fit in. STUDY DESIGN We conducted a cohort study of 313 women in Kenya who were 6-12 weeks postpartum when they started using these methods: subdermal implant (205), LNG IUS (93), and copper intrauterine device (15). Participants returned for visits at 6 and 12 months to share information on bleeding patterns, side effects, satisfaction, and continued use of the products. We used Kaplan-Meier techniques to estimate method continuation rates and chi-square tests of association to identify differences in experiences with the methods. RESULTS The 12-month continuation rate for the LNG IUS was 89.1 (95% confidence interval [CI] = 86.9-94.9) and statistically equivalent to that of the subdermal implant (91.8: 95% CI = 80.6-94.0). Nearly 87% of LNG IUS users were very satisfied with the method at 6 months compared to 75% of implant users; this gap closed somewhat at 12 months as satisfaction levels of implant users rose. At 12 months 78% of LNG IUS users felt that their bleeding pattern was highly acceptable compared with about 66% of implant users. CONCLUSIONS This study found that the LNG IUS compared favorably to the subdermal implant in terms of satisfaction levels and continued use. The LNG IUS will provide another long-acting option for postpartum women. IMPLICATIONS The LNG IUS may soon be purchased by international donor agencies for use in public sector programs in sub-Saharan Africa and other resource-poor countries. The results of this study suggest that the product will be successful in future introduction activities.

The Levonorgestrel Intrauterine System: Reasons to Expand Access to the Public Sector of Africa

The levonorgestrel intrauterine system has: (1) excellent effectiveness, (2) high satisfaction levels, (3) non-contraceptive benefits, and (4) potential to help reinvigorate interest in intrauterine contraception. The time is ripe for ministries and donor agencies to work together to make the product widely available across Africa. The levonorgestrel intrauterine system has: (1) excellent effectiveness, (2) high satisfaction levels, (3) non-contraceptive benefits, and (4) potential to help reinvigorate interest in intrauterine contraception. The time is ripe for ministries and donor agencies to work together to make the product widely available across Africa.

Opportunity, satisfaction, and regret: Trying long-acting reversible contraception in a unique scientific circumstance

ABSTRACT Increased use of long-acting reversible contraception (LARC) can reduce unintended pregnancies. However, significant barriers exist to LARC uptake, particularly high up-front costs. In North Carolina in 2014, we interviewed thirty-four purposively selected participants (aged 20–30 years) enrolled in a partially randomized patient preference trial to learn about their experiences with and attitudes toward contraception in this unique trial context. Cost of LARC was important in participants’ decision-making. Experiencing an unintended pregnancy motivated women to switch to LARC. No participants who tried LARC, even those who experienced side effects, regretted it. Several participants regretted discontinuing their LARC. Concerns about insertion and removal did not influence future willingness to try LARC. Participants discussed the importance of affordability and feeling in control when choosing a contraceptive method. Cost, combined with uncertainty over whether LARC is the right method for them, may deter young women from trying LARC. Intrauterine devices (IUDs) and implants should be made affordable so that women can try them without significant financial commitment. Affordability will likely increase uptake, which will reduce unintended pregnancies. Regret from discontinuing LARC was more frequently reported than regret from trying LARC. Providers should offer young women LARC and counsel to support continuation.