Sexual and reproductive health and rights knowledge, perceptions, and experiences of adolescent learners from three South African townships: qualitative findings from the Girls Achieve Power (GAP Year) Trial [version 2; peer review: 2 approved]

Background: Adolescence is a time of psycho-social and physiological changes, with increased associated health risks including vulnerability to pregnancy, HIV, sexually transmitted infections, and gender-based violence. Adolescent learners, from three townships in South Africa, participated in a 44 session, after-school asset-building intervention (GAP Year), over 2 years providing sexual and reproductive health (SRH) education. This paper explores adolescent learners’ SRH, sexual risk and rights knowledge; perceptions about transactional sex; and contraceptive method preferences and decision-making practices. Methods: The intervention was conducted in 13 secondary schools across Khayelitsha, Thembisa, and Soweto, South Africa. A baseline survey collected socio-demographic data prior to the intervention. Overall, 26 focus group discussions (FGDs): 13 male and 13 female learner groups, purposively selected from schools, after completing the intervention (2 years after baseline data collection). Descriptive analyses were conducted on baseline data. Qualitative data were thematically coded, and NVivo was used for data analysis. Results: In total, 194 learners participated in the FGDs. Mean age at baseline was 13.7 years (standard deviation 0.91). Participants acquired SRH and rights knowledge during the GAP Year intervention. Although transactional sex was viewed as risky, some relationships were deemed beneficial and necessary for material gain. Negative healthcare provider attitudes were the main barrier to healthcare service utilisation. There was awareness about the benefits of contraceptives, but some myths about method use. The injectable was the preferred contraceptive method, followed by the implant, with equal preference for condoms and oral pill. Conclusions: An afterschool intervention at school is a viable model for the provision of SRH and rights education to learners. Recommendations include the need for risk reduction strategies in the curriculum, dealing with misconceptions, and the promotion of informed decision making. Endeavours to ensure health services are youth friendly is a priority to limit barriers to accessing these services

Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial

INTRODUCTION : Global guidelines emphasize the ethical obligation of investigators to help participants in HIV-endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre-exposure prophylaxis (PrEP) has increasingly become part of state-of-the-art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial. METHODS : ECHO was an open-label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35 years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18 months, from 2015 to 2018. Part-way through the course of the trial, oral PrEP was provided to study participants either off-site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi-squared tests or t-tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression. RESULTS : PrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow-up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all p < 0.05). PrEP initiation did not differ across study randomized groups (p = 0.7). Two-thirds of PrEP users were continuing PrEP at study exit. CONCLUSIONS : There is a need for improved HIV prevention services in clinical trials with HIV endpoints, especially trials among African women. PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial is practical and feasible. Provision of PrEP within clinical trials with HIV outcomes should be standard of prevention.The ECHO Trial was funded by Bill & Melinda Gates Foundation, US Agency for International Development and the President’s Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council and UN Population Fund. Contraceptive supplies were donated by the Government of South Africa and US Agency for International Development. IB received funding from the South African Medical Research Council under the SAMRC Clinician Researcher MD PhD Development Programme.https://onlinelibrary.wiley.com/journal/17582652am2020Family Medicin

Guidelines to support HIV-affected individuals and couples to achieve pregnancy safely: Update 2018

No abstract available

Building capacity to facilitate policy implementation: A short course in adolescent and youth health in South Africa.

In order to respond more effectively to the health of young people in South Africa, in 2017 the National Department of Health of South Africa released the National Adolescent & Youth Health Policy. The Policy focused on a range of health problems and recommended interventions for delivery through multiple settings and government departments. It also included specific recommendations to empower and involve young people in policy and programme implementation. Adaptation of a short course on adolescent health in lowand middle-income countries, organized annually by the London School of Hygiene and Tropical Medicine and the World Health Organization, was piloted in 2017 as one means of contributing to the implementation of the Policy. The Adolescent & Youth Health Policy short course was subsequently offered in 2018 and 2019, attracting 96 participants working on adolescent health in various organizations at national and provincial levels throughout the country. Most participants (75%) successfully completed the course, as assessed by the completion criteria that had been defined. The range of topics for the assignments selected by the participants over the 3 years reflected both the content and intent of the Policy. The evaluations of the short course indicate that it helped to create legitimacy and strengthen the capacity of various constituencies, both of which are important prerequisites for policy implementation

Closing the Gap: Ensuring Access to and Quality of Contraceptive Implant Removal Services is Essential to Rights-based Contraceptive Care

The use of the subdermal contraceptive implant is increasing globally, and particularly so in lower- and middle-income countries in sub-Saharan Africa. For initiation or discontinuation of the implant, users need to have access to services for insertion and removal by healthcare providers. Providing access to safe and effective contraceptive implant removal services presents both clinical and programmatic challenges. The most challenging implant removal cases, termed ―difficult removals‖, place additional demands upon removal services. In this commentary, we outline challenges for the provision of removal services. Based on our experience in this field, we make  recommendations on how healthcare providers and health services can plan for these challenges. Through  maximising the provision of comprehensive and accessible implant removal services, including those for difficult  removals, implant users can be empowered to discontinue their use of this method of contraception if they choose, thus upholding the principles of rights-based contraceptive care.Keywords: Contraception, contraceptive implant, implant removal, difficult implant remova

Clinical outcomes of intrauterine device insertions by newly trained providers: The ECHO trial experience

Objectives: To assess the rates of failed insertion, expulsion, and perforation when intrauterine device (IUD) insertions were done by newly trained clinicians, and to examine factors that may affect these outcomes. Study design: We evaluated skill-based outcomes following IUD insertion at 12 African sites in a secondary analysis of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) randomized trial. Before trial initiation, we provided competency-based IUD training to clinicians and offered ongoing clinical support. We used Cox proportional hazards regression to examine factors associated with expulsion. Results: Among 2582 IUD acceptors who underwent first attempted IUD insertion, 141 experienced insertion failure (5.46%) and seven had uterine perforation (0.27%). Perforation was more common among breastfeeding women within three months postpartum (0.65%) compared with non-breastfeeding women (0.22%). We recorded 493 expulsions (15.5 per 100 person-years, 95% confidence interval [CI] 14.1─16.9): 383 partial and 110 complete. The risk of IUD expulsion was lower among women older than 24 years (aHR 0.63, 95% CI 0.50─0.78) and may be higher among nulliparous women. (aHR 1.65, 95% CI 0.97─2.82). Breastfeeding (aHR 0.94, 95% CI 0.72─1.22) had no significant effect on expulsion. IUD expulsion rate was highest during the first three months of the trial. Conclusions: IUD insertion failure and uterine perforation rates in our study were comparable to those reported in the literature. These results suggest that training, ongoing support, and opportunities to apply new skills were effective in ensuring good clinical outcomes for women receiving IUD insertion by newly trained providers. Implications: Data from this study support recommendations to program managers, policymakers, and clinicians that IUDs can be inserted safely in resource-constrained settings when providers receive appropriate training and support

Integrating oral PrEP delivery among African women in a large HIV endpoint‐driven clinical trial

INTRODUCTION : Global guidelines emphasize the ethical obligation of investigators to help participants in HIV-endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre-exposure prophylaxis (PrEP) has increasingly become part of state-of-the-art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial. METHODS : ECHO was an open-label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35 years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18 months, from 2015 to 2018. Part-way through the course of the trial, oral PrEP was provided to study participants either off-site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi-squared tests or t-tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression. RESULTS : PrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow-up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all p < 0.05). PrEP initiation did not differ across study randomized groups (p = 0.7). Two-thirds of PrEP users were continuing PrEP at study exit. CONCLUSIONS : There is a need for improved HIV prevention services in clinical trials with HIV endpoints, especially trials among African women. PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial is practical and feasible. Provision of PrEP within clinical trials with HIV outcomes should be standard of prevention.The ECHO Trial was funded by Bill & Melinda Gates Foundation, US Agency for International Development and the President’s Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council and UN Population Fund. Contraceptive supplies were donated by the Government of South Africa and US Agency for International Development. IB received funding from the South African Medical Research Council under the SAMRC Clinician Researcher MD PhD Development Programme.https://onlinelibrary.wiley.com/journal/17582652am2020Family Medicin

Incorporating oral PrEP into standard prevention services for South African women : a nested interrupted time-series study

BACKGROUND : As oral pre-exposure prophylaxis (PrEP) becomes the standard of prevention globally, its potential effect on HIV incidence in clinical trials of new prevention interventions is unknown, particularly for trials among women. In a trial measuring HIV incidence in African women, oral PrEP was incorporated into the standard of prevention in the trial’s last year. We assessed the effect of on-site access to PrEP on HIV incidence in this natural experiment. METHODS : We did a nested interrupted time-series study using data from the ECHO trial. At 12 sites in four countries (Eswatini, Kenya, South Africa, and Zambia), women (aged 16–35 years) were randomly assigned to receive one of three contraceptives between Dec 14, 2015, and Sept 12, 2017, and followed up quarterly for up to 18 months to determine the effect of contraceptive method on HIV acquisition. Women were eligible if they wanted long-acting contraception, were medically qualified to receive study contraceptives, and had not used any of the study contraceptives in the past 6 months. The present analyses are limited to nine South African sites where on-site access to oral PrEP was implemented between March 13 and June 12, 2018. Using an interrupted time-series design, we compared HIV incidence before versus after PrEP access, limited to quarterly study visits at which on-site PrEP access was available to at least some participants and, in a sensitivity analysis, to the 180 days before and after access. The outcome was incident HIV infection, detected using two rapid HIV tests done in parallel for each participant at every scheduled follow-up visit. This study is registered on ClinicalTrials.gov, NCT02550067. FINDINGS : 2124 women were followed up after on-site PrEP access began, of whom 543 (26%) reported PrEP use. A total of 12 HIV seroconversions were observed in 556 person-years (incidence 2·16%) after on-site PrEP access, compared with 133 HIV seroconversions in 2860 person-years (4·65%) before PrEP access (adjusted incidence rate ratio [IRR] 0·45, 95% CI 0·25–0·82, p=0·0085). Similar results were also observed when limiting the analysis to 180 days before versus after PrEP access. A total of 46 HIV seroconversions were observed in 919 person-years within 180 days before PrEP access, compared with 11 seroconversions in 481 person-years in the 180 days following PrEP access (incidence 5·00 vs 2·29 per 100 person-years; IRR 0·43, 95% CI 0·22–0·88, p=0·012). INTERPRETATION : On-site access to PrEP as part of standard of prevention in a clinical trial among women in South Africa was associated with halving HIV incidence, when approximately a quarter of women started PrEP. Providing access to on-site PrEP could decrease incidence in HIV prevention trials. These data are also among the first to show in any setting that access to PrEP is associated with decreased HIV acquisition among South African women.Bill & Melinda Gates Foundation, United States Agency for International Development, President's Emergency Plan for AIDS Relief, the Swedish International Development Cooperation Agency, South African Medical Research Council, and United Nations Population Fund.https://www.thelancet.com/journals/lanhiv/homeam2021Family Medicin