Continued attendance in a PrEP program despite low adherence and non-protective drug levels among adolescent girls and young women in Kenya: Results from a prospective cohort study.

BACKGROUND: In sub-Saharan Africa (SSA), adolescent girls and young women (AGYW) ages 15 to 24 years represent <10% of the population yet account for 1 in 5 new HIV infections. Although oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) can be highly effective, low persistence in PrEP programs and poor adherence have limited its ability to reduce HIV incidence among women. METHODS AND FINDINGS: A total of 336 AGYW participating in the PEPFAR-funded DREAMS PrEP program in western Kenya were enrolled into a study of PrEP use conducted between 6/2019 to 1/2020. AGYW, who used daily oral TDF/FTC, completed interviews and provided dried blood spots (DBS) for measurement of tenofovir-diphosphate (TFV-DP) concentrations at enrollment and 3 months later, and 176/302 (58.3%, 95% confidence interval [95% CI 52.3 to 63.8]) met our definition of PrEP persistence: having expressed intention to use PrEP and attended both the second interview and an interim refill visit. Among AGYW with DBS taken at the second interview, only 9/197 (4.6%, [95% CI 1.6 to 7.5]) had protective TFV-DP levels (≥700 fmol/punch) and 163/197 (82.7%, [95% CI 77.5 to 88]) had levels consistent with no recent PrEP use (<10 fmol/punch). Perception of being at moderate-to-high risk for HIV if not taking PrEP was associated with persistence (adjusted odds ratio, 10.17 [95% CI 5.14 to 20.13], p < 0.001) in a model accounting for county of residence and variables that had p-value <0.1 in unadjusted analysis (age, being in school, initiated PrEP 2 to 3 months before the first interview, still active in DREAMS, having children, having multiple sex partners, partner aware of PrEP use, partner very supportive of PrEP use, partner has other partners, AGYW believes that a partner puts her at risk, male condom use, injectable contraceptive use, and implant contraceptive use). Among AGYW who reported continuing PrEP, >90% indicated they were using PrEP to prevent HIV, although almost all had non-protective TFV-DP levels. Limitations included short study duration and inclusion of only DREAMS participants. CONCLUSIONS: Many AGYW persisted in the PrEP program without taking PrEP frequently enough to receive benefit. Notably, AGYW who persisted had a higher self-perceived risk of HIV infection. These AGYW may be optimal candidates for long-acting PrEP.

Persistence of oral pre-exposure prophylaxis (PrEP) among adolescent girls and young women initiating PrEP for HIV prevention in Kenya.

The Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe (DREAMS) Initiative aims to reduce HIV infections among adolescent girls and young women (AGYW) in Africa. Oral pre-exposure prophylaxis (PrEP) is offered through DREAMS in Kenya to eligible AGYW in high burden counties including Kisumu and Homa Bay. This study examines PrEP persistence among AGYW in high burden community-based PrEP delivery settings. We evaluated PrEP persistence among AGYW in the DREAMS PrEP program in Kisumu and Homa Bay using survival analysis and programmatic PrEP refill data collected between March through December 2017. Among 1,259 AGYW who initiated PrEP during the study period, the median persistence time in the program was 56 days (95% CI: 49-58 days) and the proportion who persisted 3 months later was 37% (95% CI: 34-40%). Persistence varied by county (p < 0.001), age at PrEP initiation (p = 0.002), marital status (p = 0.008), transactional sex (p = 0.002), gender-based violence (GBV) experience (p = 0.009) and current school attendance (p = 0.001) at DREAMS enrollment. Persistence did not vary with orphan status, food insecurity, condom use, age at first sexual encounter or engagement in age-disparate sex at DREAMS enrollment. Targeted strategies are needed to improve AGYW retention in the PrEP program.

Emergency contraception in Senegal: challenges and opportunities.

OBJECTIVES: This paper highlights lessons from introductory efforts and presents new data on community, provider and key opinion leader perspectives to support expanded use of emergency contraception (EC) in Senegal. SOURCES OF INFORMATION: The paper draws on four data sources: (i) a literature review; (ii) a secondary analysis of a household survey conducted by the Urban Reproductive Health Initiative; (iii) in-depth interviews with key opinion leaders; and (iv) a quantitative survey of healthcare providers from a range of service delivery points. ANALYSIS OF DATA: Knowledge of EC among women is low in urban areas, with only 20% of women having heard of the method and 4% having ever used it. There were serious gaps in providers' technical knowledge about EC; only 57% knew its mode of action and 34% were aware of the need for timely use (within 120 h). Moreover, nearly half reported reluctance to provide EC to married women and even fewer were willing to provide it to youths, particularly to adolescent girls. Responses from key opinion leaders were mixed, demonstrating ambivalence about EC and how it could be offered. CONCLUSION: In Senegal, the current positive political climate for family planning provides a good opportunity for strengthening EC programming to address knowledge and attitudinal barriers among providers, key opinion leaders and communities.

Self-care provision of contraception: Evidence and insights from contraceptive injectable self-administration.

As new reproductive health products become available, women increasingly want to take a participatory role in their health. New developments and formulations of contraceptive products provide an opportunity to support this evolving trend toward self-care. Self-care, as defined by the World Health Organization (WHO), highlights the ability of individuals to promote health, prevent disease, and manage their own health with or without the support of a health care provider. The recently released WHO Guidelines on Self-Care Interventions for Health: Sexual and Reproductive Health and Rights included new self-care recommendations related to use of family planning, including self-injection of injectable contraceptives and over-the-counter provision of oral contraceptive pills. This paper focuses on the research evidence of self-administration (self-injection) of subcutaneous depot medroxyprogesterone acetate (DMPA-SC), and the practical experience of providers, women, and family planning programs adopting self-injection practices. We also explore the role of self-care in the provision of other contraceptives.

Self-administration of injectable contraception: a systematic review and meta-analysis.

INTRODUCTION: Depot medroxyprogesterone acetate subcutaneous injectable contraception (DMPA-SC) may facilitate self-administration and expand contraceptive access. To inform WHO guidelines on self-care interventions, we conducted a systematic review and meta-analysis comparing self-administration versus provider administration of injectable contraception on outcomes of pregnancy, side effects/adverse events, contraceptive uptake, contraceptive continuation, self-efficacy/empowerment and social harms. METHODS: We searched PubMed, Cumulative Index to Nursing and Allied Health Literature, LILACS and EMBASE in September 2018 for peer-reviewed studies comparing women who received injectable contraception with the option of self-administration with women who received provider-administered injectable contraception on at least one outcome of interest. Risk of bias was assessed using the Cochrane tool for randomised controlled trials (RCTs) and the Evidence Project tool for non-randomised studies. Meta-analysis was conducted using random-effects models to generate pooled estimates of relative risk (RR). RESULTS: Six studies with 3851 total participants met the inclusion criteria: three RCTs and three controlled cohort studies. All studies examined self-injection of DMPA-SC; comparison groups were either provider-administered DMPA-SC or provider-administered intramuscular DMPA. All studies followed women through 12 months of contraceptive coverage and measured (dis)continuation of injectable contraception. Meta-analysis found higher rates of continuation with self-administration compared with provider administration in three RCTs (RR: 1.27, 95% CI 1.16 to 1.39) and three controlled cohort studies (RR: 1.18, 95% CI 1.10 to 1.26). Four studies reported pregnancies; all showed no difference across study arms. Four studies reported side effects/adverse events; while two controlled cohort studies showed increased injection site reactions with self-administration, no other side effects increased with self-administration. One study found no difference in social harms. No studies reported measuring uptake or self-efficacy/empowerment. CONCLUSION: A growing evidence base suggests that self-administration of DMPA-SC can equal or improve contraceptive continuation rates compared with provider administration. This benefit comes without notable increases in pregnancy or safety concerns. Self-injection of DMPA-SC is a promising approach to increasing contraceptive use.

A Systematic Review of Adolescent Girl Program Implementation in Low- and Middle-Income Countries: Evidence Gaps and Insights.

Increasing attention to adolescent girls has generated an abundance of programs and a growing body of research on adolescent girls in low- and middle-income countries. Despite this, questions remain about what implementation approaches in program design are most effective, hindering efficient resource allocation, program scale-up, and replication across settings. To address these questions, we conducted a systematic review to identify lessons learned and gaps in the evidence base. We searched four electronic databases to identify studies published between 1990 and 2014 that evaluated health, social, and/or economic development programs targeting adolescent girls in low- and middle-income countries. Seventy-seven (77) studies meeting specified criteria were identified, of which 19 presented results that allowed conclusions relevant to implementation science. Studies examining the following questions were assessed: To what extent, if any, do multicomponent interventions (as opposed to single-component interventions) improve outcomes for girls? What is the added value of involving actors in addition to the girl herself such as parents, guardians, husbands (i.e., multilevel interventions)? What is the threshold proportion of girls who need to participate in a program to bring about normative and behavior changes at the community level? Is a greater level of program exposure associated with greater programmatic benefit for girls? Can supplemental "booster" activities extend the benefits of a program after it ends? We found evidence to support associations between multicomponent (vs. single component) programs, and longer program exposure (vs. less program exposure), with more favorable outcomes for girls, although both conclusions include methodological limitations. Overall, few studies assessed boosters or program saturation, and evidence on multilevel versus single-level programs was inconclusive. Few studies assessed implementation science questions by design, exposing large gaps in the evidence base. We call for future research to explicitly test such implementation science questions to inform more effective use of resources and to improve outcomes for girls.

Medical barriers to emergency contraception: a cross-sectional survey of doctors in North India.

BACKGROUND: Some medical doctors in India have publicly expressed opposition to making emergency contraceptive pills (ECPs) easily accessible, even though ECPs are included in the method mix of the Ministry of Health and Family Welfare program and as an over-the-counter (OTC) product. Such opposition affects access to ECPs by influencing policy, procurement, and distribution, besides stigmatizing the ECP user. This study was conducted to assess ECP knowledge, attitudes, and practices of doctors in North India. METHODS: A cross-sectional survey of 83 doctors who provide ECPs, randomly selected from 3 cities in the state of Uttar Pradesh, was conducted in 2011. The quantitative data were complemented by 19 in-depth interviews with purposively selected senior gynecologists and other opinion leaders. RESULTS: All surveyed physicians cited the correct dose and regimen for ECPs. However, the large majority of those surveyed believed that ECPs work by preventing implantation. (The best evidence currently indicates that ECPs do not work by preventing implantation.) Most doctors also believed incorrectly that ECPs have several contraindications and side effects. They also had strong reservations against OTC provision of ECPs by pharmacists and community health workers (CHWs) and negative attitudes toward ECP users, which serve as serious medical barriers to mainstreaming use of ECPs. CONCLUSION: Physicians and their professional associations exert a strong influence on the operationalization of national contraceptive policies. Evidence-based advocacy and educational campaigns targeting doctors are needed to address and resolve their reservations about ECPs, particularly about its provision as an OTC product and its distribution by CHWs. Partnerships with medical associations can help reduce doctors' negative attitudes and create a conducive environment for influencing clinical practices. Such changes are needed to increase the availability and use of ECPs as part of a package of a full range of contraceptive method options to prevent unwanted pregnancy among the most vulnerable populations.

Lessons from reproductive health to inform multipurpose prevention technologies: don't reinvent the wheel.

UNLABELLED: This paper presents the public health rationale for multipurpose prevention technologies (MPTs) for sexual and reproductive health (SRH) based on regional trends in demographic and SRH indicators. It then distils important lessons gleaned from the introduction of contraceptive and reproductive health products over the past several decades in order to inform the development and future introduction of MPTs for SRH. PRINCIPAL RESULTS: A comparison of current demographic and public health regional data clearly revealed that the greatest confluence of women's SRH concerns occurs in sub-Saharan Africa and South/West Asia. These regional overlaps of SRH risks and outcomes present a strong rationale for developing MPTs designed to simultaneously protect against unintended pregnancy, HIV and other STIs. Information from acceptability, marketing, and operations research on the female condom, emergency contraception, pills and intravaginal rings identified key product characteristics and socio-behavioral issues to be considered in the development and introduction of MPTs. Product characteristics such as formulation, duration of action, presence and magnitude of side effects, prescription status (over-the-counter vs. prescribed), provider type and training and user perspectives, all contributed in varying degrees to both provider and user bias, and subsequent uptake of these family planning methods. Underlying socio-behavioral issues, including risk perception, ambivalence, and social costs also contributed to demand and use. Early identification of target populations will be critical to market shaping, demand creation and defining appropriate service delivery channels for MPTs. Ultimately, knowledge, attitudes, perceptions and practices of users (and their partners) will drive the success- or failure- of product introduction. CONCLUSIONS: MPTs provide a compelling response to the multiple and reinforcing SRH risks faced by women in key regions of the world, but specific product characteristics and their socio-behavioral correlates must be taken into account early in the development process. Successful introduction of new MPTs will require solid understanding of socio-behavioral correlates, effective demand generation, appropriate integration into health service delivery systems, quality counseling for proper use and active engagement of both public and private sectors. This article is based on a presentation at the "Product Development Workshop 2013: HIV and Multipurpose Prevention Technologies," held in Arlington, Virginia on February 21-22, 2013. It forms part of a special supplement to Antiviral Research.

Preventing sexually transmitted infections and unintended pregnancy, and safeguarding fertility: triple protection needs of young women.

The problems and risks of unprotected sex, unintended pregnancy and sexually transmitted infections are inextricably linked. In this context, the critical yet overlooked problem of infertility also needs to be addressed. Dual protection means concurrent protection against unintended pregnancy and STI/HIV. This paper argues for a more comprehensive notion of "triple protection" to include the safeguarding of fertility. This is intended explicitly to draw out the connection between infertility and STIs--using the "visibility" of fertility and infertility and people's immediate connection with them--and in so doing to bolster STI prevention and control efforts. It could also serve to highlight the connections between infertility and unsafe abortion and delivery practices, which still exist in many developing countries. Understanding differences in perception and weighting of protection concerns by young women and men, whether they wish to start, postpone or avoid pregnancy, is essential for the creation of effective programmes. Building on efforts to promote dual protection, a strategic opportunity exists to include prevention of infertility into safer sex messages and to address the fragmentation of reproductive health and HIV/AIDS programmes.