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.

Eita! Reaching Communities and Young People to Drive Demand for Oral Pre-Exposure Prophylaxis in South Africa.

PURPOSE: This paper describes a holistic but flexible demand creation strategy for pre-exposure prophylaxis (PrEP) in national public health-care settings in low-income to middle-income countries. METHODS: We describe the development and implementation of a model to drive demand for oral PrEP uptake and use as part of comprehensive sexual and reproductive health services in South Africa: The Eita! MODEL: The project adapted two existing response hierarchy models (marketing models used to describe the stages individuals move through from being unaware to using a product), to formulate the Eita! MODEL: Using the RE-AIM framework, we report on the reach, effectiveness, adoption, implementation, and maintenance of the Eita! RESULTS: More than 34 million connections were made from December 2018 to 2021 through a variety of channels: social media and websites, at events and mobile clinic outreach, and radio and community dialogs. There were 42,447 adolescent girls and young women reached in-person during this time, 16,823 adolescent girls and young women presented for sexual and reproductive health services, and of those 14,637 (87%) initiated on PrEP. The model was implemented in eight health-care facilities and four mobile clinics in three provinces in South Africa. A total of 26 trainings were delivered to project staff implementing the strategy. Various demand creation resources, such as materials and online platforms, have since been adopted by the National Department of Health as national tools. DISCUSSION: The Eita! model was successfully implemented to support the uptake of HIV prevention services and rollout of biomedical prevention products, and can be adapted by other low-income to middle-income countries.

Implementing Differentiated and Integrated HIV Prevention Services for Adolescent Girls and Young Women: Experiences From Oral PrEP Rollout in Primary Care Services in South Africa.

PURPOSE: In South Africa, adolescent girls and young women (AGYW, aged 15-24 years) are disproportionately affected by human immunodeficiency viruses (HIV). Oral pre-exposure prophylaxis (PrEP) has been available in South Africa since 2016; however, there is limited evidence on oral PrEP implementation and integration in real-world settings, particularly among AGYW. Project PrEP is an implementation science project that sought to inform the introduction and integration of oral PrEP as part of combination HIV prevention and sexual and reproductive health services (SRH) in South Africa. The project focused on AGYW, as a priority population in need of HIV prevention. This paper presents strategies Project PrEP employed to increase oral PrEP and SRH service access and utilization. METHODS: We present strategies employed to increase oral PrEP and SRH services uptake. Using routine monitoring data, facility assessments, stakeholder engagement, training and progress reports, and observations, we share implementation lessons learned and describe how strategies can be adapted by HIV prevention programs in different contexts. RESULTS: Approximately 22, 000 people initiated on oral PrEP (December 2018-December 2021) across eight facilities and four mobile clinics. Two-thirds (67%) of initiated clients were AGYW. DISCUSSION: Lessons are to be learned from the introduction of oral PrEP as implementers prepare for the introduction of new PrEP methods. Stakeholders must be continuously engaged to ensure buy-in, and social mobilization and demand creation should be contextual, focused, and innovative. Continuous staff training is needed to reinforce knowledge, and AGYW service delivery models must be local context relevant.

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.

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.

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.

Contraception knowledge and uptake among in-school adolescents in three South African townships: Baseline findings from the Girls Achieve Power (GAP Year) Trial.

Background: South African adolescents experience barriers to sexual and reproductive health (SRH) knowledge and uptake. This study provides insight into contraceptive and other SRH service knowledge, perceptions, and uptake among adolescents in high HIV prevalence settings. Methods: A baseline cross sectional survey was conducted among 3432 grade 8s enrolled into the Girls Achieve Power (GAP Year) trial from 26 public high schools across three South African townships (Soweto, Thembisa and Khayelitsha) (2017 - 2018). An interviewer-led survey collected information on SRH knowledge and perceptions; an audio computer-assisted self-interviewing technique gathered SRH service uptake. Descriptive analysis indicates frequency distribution of socio-demographics and knowledge, uptake and perceptions of SRH services. Chi-square test tested for associations between age and sex and selected variables that measure SRH knowledge and uptake. Results: In total, 2383 learners, completed both survey components. Of these, 63.1% (n=1504) were female and 81.4% (n=1938) aged 12-14. Almost a fifth (18.3%, n=436) had ever had sex and less than 1% had accessed SRH services in the last year. Of the 157 females who had ever had sex, 50.9% had ever used contraception. Of those who had sex in the last three months, 59.0% reported using a contraceptive method. Condom use was inconsistent: almost all females said they had not used or could not remember if a condom was used at last sex. Conclusion: This paper contributes to the evidence strengthening learner SRH education, including the national Integrated School Health Programme. Key themes include the need for age-appropriate, differentiated comprehensive sexuality education (CSE) for the range of ages found in the same grade in South African schools. Education on different contraceptive methods, informed decision-making, and emergency contraception is key. School-based interventions should embrace integrated HIV, STI, and pregnancy prevention messages. Closer links with health services need to be constantly fostered and reinforced.

Introduction and integration of PrEP and sexual and reproductive health services for young people: Health provider perspectives from South Africa.

South Africa has one of the largest HIV epidemics in the world, with particularly high prevalence among adolescent girls and young women (AGYW). Oral PrEP was introduced in the public sector in 2016 in a phased manner. Given the important role played by health providers, research was undertaken to understand their experiences of and attitudes towards introduction of PrEP as a new HIV prevention method, and its integration within broader sexual and reproductive health (SRH) services for youth. A survey was undertaken with 48 purposively sampled health providers working in primary health care facilities and mobile clinics in three provinces in South Africa. Qualitative analysis was performed on free-text responses to open-ended questions in the survey, using an inductive approach to code the data in NVivo v.12 software. Health providers expressed concerns about adding a new service to an already overburdened health system, and worried that young people seeking PrEP would divert staff from other critical services. While most recognised the benefits and opportunities afforded by HIV and SRH service integration, providers highlighted the extra time and resources such integration would require. Many were anxious that PrEP would encourage disinhibition and increase unprotected sex among AGYW, and held judgemental attitudes about young people, seen as largely incapable of taking responsibility for their health. Findings underscore the importance of consulting health providers about implementation design and providing channels for them to express their misgivings and concerns, and training needs to be designed to address provider attitudes and values. Opportunities need to be sought to strengthen the provision of adolescent and youth friendly services-including adolescent-health provider dialogues. Insights from this study can assist in guiding the introduction of new HIV prevention methods into the future.

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.

High HIV incidence among young women in South Africa: Data from a large prospective study.

INTRODUCTION: South Africa has the highest national burden of HIV globally. Understanding drivers of HIV acquisition in recently completed, prospective studies in which HIV was an endpoint may help inform the strategy and investments in national HIV prevention efforts and guide the design of future HIV prevention trials. We assessed HIV incidence and correlates of incidence among women enrolled in ECHO (Evidence for Contraceptive Options and HIV Outcomes), a large, open-label randomized clinical trial that compared three highly effective. reversible methods of contraception and rates of HIV acquisition. METHODS: During December 2015 to October 2018, ECHO followed sexually active, HIV-seronegative women, aged 16-35 years, seeking contraceptive services and willing to be randomized to one of three contraceptive methods (intramuscular depot medroxyprogesterone acetate, copper intrauterine device, or levonorgestrel implant) for 12-18 months at nine sites in South Africa. HIV incidence based on prospectively observed HIV seroconversion events. Cox proportional hazards regression models were used to define baseline cofactors related to incident HIV infection. RESULTS: 5768 women were enrolled and contributed 7647 woman-years of follow-up. The median age was 23 years and 62.5% were ≤24 years. A total of 345 incident HIV infections occurred, an incidence of 4.51 per 100 woman-years (95%CI 4.05-5.01). Incidence was >3 per 100 woman-years at all sites. Age ≤24 years, baseline infection with sexually transmitted infections, BMI≤30, and having new or multiple partners in the three months prior to enrollment were associated with incident HIV. CONCLUSIONS: HIV incidence was high among South African women seeking contraceptive services. Integration of diagnostic management of sexually transmitted infections alongside delivery of HIV prevention options in health facilities providing contraception services are needed to mitigate ongoing risks of HIV acquisition for this vulnerable population. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02550067 was the main Clinical Trial from which this secondary, non-randomized / observational analysis was derived with data limited to just South African sites.

Uptake of Contraception Among Adolescent Girls and Young Women PrEP Clients: Leveraging the Opportunity to Strengthen HIV and Sexual and Reproductive Health Integration.

The introduction of oral pre-exposure prophylaxis (PrEP) for HIV prevention was a major breakthrough in South Africa (SA). While the initial introduction focused on issues such as the development and implementation of new guidelines, supply, and the development of demand creation strategies, the need to integrate PrEP services with sexual and reproductive health (SRH) services has gained traction both globally and locally. Project PrEP was implemented in eight healthcare facilities and four mobile clinics in three provinces in SA. Using monitoring data from across the four project clusters, and 4,949 clients, over a 21-month period, we conducted an analysis of baseline routine monitoring data to examine contraceptive uptake in adolescent girls and young women (AGYW) initiating PrEP at project sites. Two-thirds of women (62.3%, n = 3,083) reported the current use of contraception at baseline, with the most commonly used methods being hormonal injectables (61.9%, n = 1,829) and male condoms (19.4%, n = 575). A third (32.3%, n = 603) of the non-contraceptive users accepted a method at PrEP initiation. From a total of 1,007 (32.7%) current contraceptive users at baseline, 865 (85.9%) chose the same or a different method at this visit. The method uptake at PrEP initiation increased the overall contraceptive prevalence by 12.2 to 74.5%. Data indicated that over a third (38.8%, n = 725) who were not using a method at baseline described themselves as consistent condom users. Although a major focus of the project was on PrEP service provision, all women were counseled and offered contraceptive services. The acceptance of a method by a third of non-users was promising; however, more understanding of those who did not take up a method is required. The need to leverage opportunities for the promotion of the integration of HIV and family planning at all levels of PrEP provision was highlighted.

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. FUNDING: 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.

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.

Doing more for less: identifying opportunities to expand public sector access to safe abortion in South Africa through budget impact analysis.

OBJECTIVE(S): To estimate the costs of public-sector abortion provision in South Africa and to explore the potential for expanding access at reduced cost by changing the mix of technologies used. STUDY DESIGN: We conducted a budget impact analysis using public sector abortion statistics and published cost data. We estimated the total costs to the public health service over 10 years, starting in South Africa's financial year 2016/17, given four scenarios: (1) holding service provision constant, (2) expanding public sector provision, (3) changing the abortion technologies used (i.e. the method mix), and (4) expansion plus changing the method mix. RESULTS: The public sector performed an estimated 20% of the expected total number of abortions in 2016/17; 26% and 54% of all abortions were performed illegally or in the private sector respectively. Costs were lowest in scenarios where method mix shifting occurred. Holding the proportion of abortions performed in the public-sector constant, shifting to more cost-effective service provision (more first-trimester services with more medication abortion and using the combined regimen for medical induction in the second trimester) could result in savings of $28.1 million in the public health service over the 10-year period. Expanding public sector provision through elimination of unsafe abortions would require an additional $192.5 million. CONCLUSIONS: South Africa can provide more safe abortions for less money in the public sector through shifting the methods provided. More research is needed to understand whether the cost of expanding access could be offset by savings from averting costs of managing unsafe abortions. IMPLICATIONS: South Africa can provide more safe abortions for less money in the public sector through shifting to more first-trimester methods, including more medication abortion, and shifting to a combined mifepristone plus misoprostol regimen for second trimester medical induction. Expanding access in addition to method mix changes would require additional funds.

An Analysis of Adolescent Content in South Africa's Contraception Policy Using a Human Rights Framework.

PURPOSE: To evaluate whether the updated South African national contraception policy and guidelines adequately address the needs of adolescents. METHODS: We used the World Health Organization (WHO) guidance and recommendations on ensuring human rights in the provision of contraceptive information and services as an analytic framework. We assessed the South African policy in relation to each WHO summary recommendation. Specifically, we determined where normative guidance pertaining to adolescents is present and whether it is adequate, normative guidance pertaining to all populations but not specifically adolescents is present, or normative guidance for that recommendation is missing from the policy. We developed an analytic table to discuss with coauthors and draw conclusions. RESULTS: We found specific guidance for adolescents relating to 6/9 WHO summary recommendations and 11/24 subrecommendations. Adolescents are highlighted throughout the policy as being at risk for discrimination or coercion, and laws protecting the rights of adolescents are cited. Confidentiality of services for young people is emphasized, and youth-friendly services are described as a key element of service delivery. Areas to strengthen include the need for normative guidance ensuring both availability of contraceptive information and services for young people and adolescent participation in development of community programs and services. CONCLUSIONS: South Africa's contraception policy and guidelines are comprehensive and forward looking. Nevertheless, there are gaps that may leave adolescents vulnerable to discrimination and coercion and create barriers to accessing contraceptive services. These findings provide insight for the revision and development of adolescent health policies in South Africa and other settings.