A mixed methods process evaluation: understanding the implementation and delivery of HIV prevention services integrated within sexual reproductive health (SRH) with or without peer support amongst adolescents and young adults in rural KwaZulu-Natal, South Africa.

BACKGROUND: Combination prevention interventions, when integrated with community-based support, have been shown to be particularly beneficial to adolescent and young peoples' sexual and reproductive health. Between 2020 and 2022, the Africa Health Research Institute in rural South Africa conducted a 2 × 2 randomised factorial trial among young people aged 16-29 years old (Isisekelo Sempilo) to evaluate whether integrated HIV and sexual and reproductive health (HIV/SRH) with or without peer support will optimise delivery of HIV prevention and care. Using mixed methods, we conducted a process evaluation to provide insights to and describe the implementation of a community-based peer-led HIV care and prevention intervention targeting adolescents and young people. METHODS: The process evaluation was conducted in accordance with the Medical Research Council guidelines using quantitative and qualitative approaches. Self-completed surveys and clinic and programmatic data were used to quantify the uptake of each component of the intervention and to understand intervention fidelity and reach. In-depth individual interviews were used to understand intervention experiences. Baseline sociodemographic factors were summarised for each trial arm, and proportions of participants who accepted and actively engaged in various components of the intervention as well as those who successfully linked to care were calculated. Qualitative data were thematically analysed. RESULTS: The intervention was feasible and acceptable to young people and intervention implementing teams. In particular, the STI testing and SRH components of the intervention were popular. The main challenges with the peer support implementation were due to fidelity, mainly because of the COVID-19 pandemic. The study found that it was important to incorporate familial support into interventions for young people's sexual health. Moreover, it was found that psychological and social support was an essential component to combination HIV prevention packages for young people. CONCLUSION: The results demonstrated that peer-led community-based care that integrates SRH services with HIV is a versatile model to decentralise health and social care. The family could be a platform to target restrictive gender and sexual norms, by challenging not only attitudes and behaviours related to gender among young people but also the gendered structures that surround them.

Effectiveness of integrating HIV prevention within sexual reproductive health services with or without peer support among adolescents and young adults in rural KwaZulu-Natal, South Africa (Isisekelo Sempilo): 2 × 2 factorial, open-label, randomised controlled trial.

BACKGROUND: Approximately 200 000 South Africans acquired HIV in 2021 despite the availability of universal HIV test and treat and pre-exposure prophylaxis (PrEP). The aim of this study was to test the effectiveness of sexual and reproductive health services or peer support, or both, on the uptake of serostatus neutral HIV services or reduction of sexually transmissible HIV. METHODS: We did an open-label, 2 × 2 randomised factorial trial among young people in a mostly rural area of KwaZulu-Natal, South Africa. Inclusion criteria included being aged 16-29 years, living in the mapped geographical areas that were accessible to the area-based peer navigators, being willing and able to provide informed consent, and being willing to provide a dried blood spot for anonymous HIV testing and HIV viral load measurement at 12 months. Participants were randomly allocated by computer-generated algorithm to one of four groups: those in the standard-of-care group were referred to youth-friendly services for differentiated HIV prevention (condoms, universal HIV test and treat with antiretroviral therapy, and PrEP if eligible); those in the sexual and reproductive health services group received baseline self-collected specimens for sexually transmitted infection (STI) testing and referral to integrated sexual and reproductive health and HIV prevention services; those in the peer support group were referred to peer navigators for health promotion, condom provision, and facilitation of attendance for differentiated HIV prevention services; and those in the final group received a combination of sexual and reproductive health services and peer support. Coprimary outcomes were linkage to clinical services within 60 days of enrolment, proportion of participants who had sexually transmissible HIV at 12 months after enrolment, and proportion of sampled individuals who consented to participation and gave a dried blood spot for HIV testing at 12 months. Logistic regression was used for analyses, and adjusted for age, sex, and rural or peri-urban area of residence. This study is registered with ClinicalTrials.gov (NCT04532307) and is closed. FINDINGS: Between March 2, 2020, and July 7, 2022, 1743 (75·7%) of 2301 eligible individuals were enrolled and followed up. 12-month dried blood spots were collected from 1168 participants (67·0%). The median age of the participants was 21 years (IQR 18-25), 51·4% were female, and 51·1% had secondary level education. Baseline characteristics and 12-month outcome ascertainment were similar between groups. 755 (43·3%) linked to services by 60 days. 430 (49·8%) of 863 who were in the sexual reproductive health services group were linked to care compared with 325 (36·9%) of 880 who were not in the sexual and reproductive health services group (adjusted odds ratio [aOR] 1·68; 95% CI 1·39-2·04); peer support had no effect: 385 (43·5%) of 858 compared with 370 (43·1%) of 885 (1·02, 0·84-1·23). At 12 months, 227 (19%) tested ELISA-positive for HIV, of whom 41 (18%) had viral loads of 400 copies per mL; overall prevalence of transmissible HIV was 3·5%. 22 (3·7%) of 578 participants in the sexual and reproductive health services group had transmissible HIV compared with 19 (3·3%) of 590 not in the sexual and reproductive health services group (aOR 1·12; 95% CI 0·60-2·11). The findings were also non-significant for peer support: 21 (3·3%) of 565 compared with 20 (3·3%) of 603 (aOR 1·03; 95% CI 0·55-1·94). There were no serious adverse events or deaths during the study. INTERPRETATION: This study provides evidence that STI testing and sexual and reproductive health services create demand for serostatus neutral HIV prevention in adolescents and young adults in Africa. STI testing and integration of HIV and sexual health has the potential to reach those at risk and tackle unmet sexual health needs. FUNDING: US National Institute of Health, Bill & Melinda Gates Foundation, and 3ie.

Uptake of multi-level HIV interventions and HIV-related behaviours among young people in rural South Africa.

Combination HIV prevention packages have reduced HIV incidence and improved HIV-related outcomes among young people. However, there is limited data on how package components interact to promote HIV-related prevention behaviours. We described the uptake of HIV prevention interventions supported by Determined, Resilient, Empowered, AIDS-free, Motivated and Safe (DREAMS) Partnership and assessed the association between uptake and HIV-related behaviours among young people in rural KwaZulu-Natal, South Africa. We analysed two cohorts followed from May 2017 to December 2019 to evaluate the impact of DREAMS, covering 13-29 year-old females, and 13-35 year-old males. DREAMS interventions were categorised as healthcare-based or social. We described the uptake of interventions and ran logistic regression models to investigate the association between intervention uptake and subsequent protective HIV-related outcomes including no condomless sex and voluntary medical male circumcision (VMMC). For each outcome, we adjusted for socio-demographics and sexual/pregnancy history and reported adjusted odds ratios (aOR) and 95% confidence intervals (CI). Among 5248 participants, uptake of healthcare interventions increased from 2018 to 2019 by 8.1% and 3.7% for males and females respectively; about half of participants reported receiving both healthcare and social interventions each year. The most utilised combinations of interventions included HIV testing and counselling, school-based HIV education and cash transfers. Participation in social interventions only compared to no intervention was associated with reduced condomless sex (aOR = 1.60, 95%CI: 1.03-2.47), while participation in healthcare interventions only was associated with increased condomless sex. The uptake of interventions did not significantly affect subsequent VMMC overall. Among adolescent boys, exposure to school-based HIV education, cash transfers and HIV testing and counselling was associated with increase in VMMC (aOR = 1.79, 95%CI: 1.04-3.07). Multi-level HIV prevention interventions were associated with an increase in protective HIV-related behaviours emphasizing the importance of accessible programs within both school and community settings for young people.

Prevalence of Curable Sexually Transmitted Infections in a Population-Representative Sample of Young Adults in a High HIV Incidence Area in South Africa.

BACKGROUND: Recent population-representative estimates of sexually transmitted infection (STI) prevalence in high HIV burden areas in southern Africa are limited. We estimated the prevalence and associated factors of 3 STIs among adolescents and young adults (AYA) in rural South Africa. METHODS: Between March 2020 and May 2021, a population-representative sample of AYA aged 16 to 29 years were randomly selected from a Health and Demographic Surveillance Site in rural KwaZulu-Natal, South Africa, for a 2 × 2 factorial randomized controlled trial. Participants in 2 intervention arms were offered baseline testing for gonorrhea, chlamydia, and trichomoniasis using GeneXpert. Prevalence estimates were weighted for participation bias, and logistic regression models were used to assess factors associated with STIs. RESULTS: Of 2323 eligible AYA, 1743 (75%) enrolled in the trial. Among 863 eligible for STI testing, 814 (94%) provided specimens (median age of 21.8 years, 52% female, and 71% residing in rural areas). Population-weighted prevalence estimates were 5.0% (95% confidence interval [CI], 4.2%-5.8%) for gonorrhea, 17.9% (16.5%-19.3%) for chlamydia, 5.4% (4.6%-6.3%) for trichomoniasis, and 23.7% (22.2%-25.3%) for any STI. In multivariable models, female sex (adjusted odds ratio [aOR], 2.24; 95% CI, 1.48-3.09) and urban/periurban (vs. rural) residence (aOR, 1.48; 95% CI, 1.02-2.15) were associated with STIs; recent migration was associated with lower odds of STI (aOR, 0.37; 95% CI, 0.15-0.89). Among those with an STI, 53 (31.0%) were treated within 7 days; median time to treatment was 11 days (interquartile range, 6-77 days). CONCLUSIONS: We identified a high prevalence of curable STIs among AYA in rural South Africa. Improved access to STI testing to enable etiologic diagnosis and rapid treatment is needed.

Thetha Nami ngithethe nawe (Let's Talk): a stepped-wedge cluster randomised trial of social mobilisation by peer navigators into community-based sexual health and HIV care, including pre-exposure prophylaxis (PrEP), to reduce sexually transmissible HIV amongst young people in rural KwaZulu-Natal, South Africa.

BACKGROUND: Antiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality and incidence. Effective ART based prevention has not translated into population-level impact in southern Africa due to sub-optimal coverage among youth. We aim to investigate the effectiveness, implementation and cost effectiveness of peer-led social mobilisation into decentralised integrated HIV and sexual reproductive health (SRH) services amongst adolescents and young adults in KwaZulu-Natal (KZN). METHODS: We are conducting a type 1a hybrid effectiveness/implementation study, with a cluster randomized stepped-wedge trial (SWT) to assess effectiveness and a realist process evaluation to assess implementation outcomes. The SWT will be conducted in 40 clusters in rural KZN over 45 months. Clusters will be randomly allocated to receive the intervention in period 1 (early) or period 2 (delayed). 1) Intervention arm: Resident peer navigators in each cluster will approach young men and women aged 15-30 years living in their cluster to conduct health, social and educational needs assessment and tailor psychosocial support and health promotion, peer mentorship, and facilitate referrals into nurse led mobile clinics that visit each cluster regularly to deliver integrated SRH and differentiated HIV prevention (HIV testing, UTT for those positive, and PrEP for those eligible and negative). Standard of Care is UTT and PrEP delivered to 15-30 year olds from control clusters through primary health clinics. There are 3 co-primary outcomes measured amongst cross sectional surveys of 15-30 year olds: 1) effectiveness of the intervention in reducing the prevalence of sexually transmissible HIV; 2) uptake of universal risk informed HIV prevention intervention; 3) cost of transmissible HIV infection averted. We will use a realist process evaluation to interrogate the extent to which the intervention components support demand, uptake, and retention in risk-differentiated biomedical HIV prevention. DISCUSSION: The findings of this trial will be used by policy makers to optimize delivery of universal differentiated HIV prevention, including HIV pre-exposure prophylaxis through peer-led mobilisation into community-based integrated adolescent and youth friendly HIV and sexual and reproductive health care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier-NCT05405582. Registered: 6th June 2022.

Evaluating use of mass-media communication intervention 'MTV-Shuga' on increased awareness and demand for HIV and sexual health services by adolescent girls and young women in South Africa: an observational study.

OBJECTIVE: To investigate the effect of exposure to MTV Shuga:Down South' (MTVShuga-DS) during the scale-up of combination HIV-prevention interventions on awareness and uptake of sexual reproductive health (SRH) and HIV-prevention services by adolescent girls and young women (AGYW). DESIGN: One longitudinal and three cross-sectional surveys of representative samples of AGYW. SETTING: AGYW in four South African districts with high HIV prevalence (>10%) (May 2017 and September 2019). PARTICIPANTS: 6311 AGYW aged 12-24. MEASURES: Using logistic regression, we measured the relationship between exposure to MTV Shuga-DS and awareness of pre-exposure prophylaxis (PrEP), condom use at last sex, uptake of HIV-testing or contraception, and incident pregnancy or herpes simplex virus 2 (HSV-2) infection. RESULTS: Within the rural cohort 2184 (85.5%) of eligible sampled individuals were enrolled, of whom 92.6% had at least one follow-up visit; the urban cross-sectional surveys enrolled 4127 (22.6%) of eligible sampled individuals. Self-report of watching at least one MTV Shuga-DS episode was 14.1% (cohort) and 35.8% (cross-section), while storyline recall was 5.5% (cohort) and 6.7% (cross-section). In the cohort, after adjustment (for HIV-prevention intervention-exposure, age, education, socioeconomic status), MTVShuga-DS exposure was associated with increased PrEP awareness (adjusted OR (aOR) 2.06, 95% CI 1.57 to 2.70), contraception uptake (aOR 2.08, 95% CI 1.45 to 2.98) and consistent condom use (aOR 1.84, 95% CI 1.24 to 2.93), but not with HIV testing (aOR 1.02, 95% CI 0.77 to 1.21) or acquiring HSV-2 (aOR 0.92, 95% CI 0.61 to 1.38). In the cross-sections, MTVShuga-DS was associated with greater PrEP awareness (aOR 1.7, 95% CI 1.20 to 2.43), but no other outcome. CONCLUSIONS: Among both urban and rural AGYW in South Africa, MTVShuga-DS exposure was associated with increased PrEP awareness and improved demand for some HIV prevention and SRH technologies but not sexual health outcomes. However, exposure to MTVShuga-DS was low. Given these positive indications, supportive programming may be required to raise exposure and allow future evaluation of edu-drama impact in this setting.

Impact of DREAMS interventions on experiences of violence among adolescent girls and young women: Findings from population-based cohort studies in Kenya and South Africa.

DREAMS aims to reduce HIV incidence among adolescent girls and young women (AGYW) by tackling drivers of HIV risk including gender-based violence. We evaluate the impact of DREAMS on recent experiences of violence perpetuated by men against AGYW. AGYW cohorts were randomly selected from demographic platforms in South Africa (rural KwaZulu-Natal) and Kenya (Nairobi informal settlements and rural Gem sub-county). AGYW aged 13-22 years were enrolled in 2017 (Nairobi, KwaZulu-Natal) or 2018 (Gem), with annual follow-up to 2019. We described proportions of AGYW who self-reported experiences of violence perpetrated by males in the 12 months preceding the interview, overall and by form (physical, sexual, emotional). We investigated associations with DREAMS (invitation to participate during 2017-2018) through multivariable propensity score-adjusted logistic regression and estimated the causal effect of DREAMS on experiences of violence, under counter-factual scenarios in which all versus no AGYW were DREAMS beneficiaries. Among 852, 1018 and 1712 AGYW followed-up in 2019 in Nairobi, Gem and KZN, respectively, proportions reporting any violence in 2019 were higher in Nairobi (29%) than Gem (18%) and KwaZulu-Natal (19%). By sub-type, emotional and physical violence were more frequently reported than sexual violence. We found no evidence of an impact attributable to DREAMS on overall levels of violence, in any setting. Nor was there evidence of impact on sub-types of violence, with one exception: an increase in physical violence in Nairobi if all, versus no, AGYW were DREAMS beneficiaries (16% vs 11%; +5% difference [95% CI: +0.2%, +10.0%]). Experiences of gender-based violence were common among AGYW, especially in urban settings, and DREAMS had no measurable impact on reducing violence within three years of implementation. Violence prevention programming that reaches more men and the broader community, sustained for longer periods, may yield greater gains in violence reduction than AGYW-focused programming. Additionally, more investment in implementation research is needed to bridge trial-based study findings from efficacy to population-level effectiveness.

A qualitative exploration of the salience of MTV-Shuga, an edutainment programme, and adolescents' engagement with sexual and reproductive health information in rural KwaZulu-Natal, South Africa.

Young people, particularly adolescent girls and young women, represent a growing proportion of those living with HIV. Edutainment programmes have been widely used throughout the world to "educate" and "entertain" audiences and tackle serious social issues in bold and engaging ways. This paper examines the extent to which an edutainment programme, MTV-Shuga, was reported to influence young people's engagement with sexual and reproductive health (SRH) information in rural KwaZulu-Natal, South Africa. In 2019 we conducted eight community-based screenings of MTV-Shuga episodes followed by 25 individual in-depth interviews and 13 focus group discussions with young people aged between 15 and 30. Interviews were audio recorded and transcribed verbatim. Data analysis was thematic and complemented by constant comparison and deviant case analysis techniques. In this rural and poor setting with a high burden of HIV, young people exhibited high levels of awareness of SRH and HIV but had constrained access to services, and limited ability to engage with parents or guardians on SRH matters. MTV Shuga provided an entertaining guide of ways to navigate the risks that they faced in a way that resonated with them. The findings highlight the importance of enabling young people in rural areas to watch MTV Shuga with peers in a safe space in which discussion of the content is facilitated. There is also value in encouraging parents to watch MTV Shuga as a means of enabling discussions between children and adults in their lives about SRH matters.

The sexual and reproductive health needs of school-going young people in the context of COVID-19 in rural KwaZulu-Natal, South Africa.

Background: The impact of school closures due to COVID-19 raised widespread concerns about children's health and well-being. We examine the impact on the sexual health needs of learners in the context of COVID-19 related lockdowns in rural KwaZulu-Natal, South Africa.Methods: In july-November 2020 and August-November 2021 we conducted 24 in-depth interviews and 8 group discussions with teachers and learners from 4 schools, community members and key education stakeholders. All interviews were conducted by telephone. We used a thematic analysis approach and Nvivo 12 software to manage the data.Results: Four main themes related to the COVID-19 pandemic emerged from the data: the sexual and reproductive health (SRH) of learners in the lead-up to the pandemic; the impact of COVID-19 on learners' SRH and wellbeing; the opportunities schools provided to support sexual well-being of learners during the pandemic; and the role of schools in supporting SRH for learners during the pandemic. Learners and stakeholders reported that the SRH of young people was affected by alcohol misuse, poor SRH knowledge and few pathways to link learners with services. Stakeholders working with schools reported that a lack of access to biomedical interventions (e.g., contraception) increased learner pregnancies. Gender-based violence in learners' households was reported to have increased during the COVID-19 pandemic related to loss of income. School closures disrupted the provision of a safe space to provide SRH and HIV-education through Life Orientation lessons and school nurse talks. This loss of a safe space also left learners vulnerable to sexual and physical violence. However, once schools re-opened, daily COVID-19 screening in schools provided the opportunity to identify and support vulnerable children who had other social needs (food and uniforms).Conclusion: The COVID-19 pandemic may have increased SRH needs and vulnerability of school-going children in a high HIV-burden rural setting. School shutdowns reduced the opportunity for schools to provide a vital safe space and information to enhance SRH for adolescents. Schools play a vital health promotion and social protection role.

Awareness and uptake of the Determined, Resilient, Empowered, AIDS-free, Mentored and Safe HIV prevention package over time among population-based cohorts of young women in Kenya and South Africa.

OBJECTIVES: To evaluate uptake of a complex intervention for HIV prevention among general populations of adolescent girls and young women (AGYW) in three diverse settings. DESIGN: Cohorts of ∼1500 AGYW were randomly selected from demographic platforms in Kenya (Nairobi and Siaya) and South Africa (uMkhanyakude, KwaZulu-Natal). METHODS: AGYW aged 13/15-22 years were enrolled in 2017 (Nairobi and uMkha-nyakude) or 2018 (Siaya), with annual follow-up to 2019. We describe awareness of DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored and Safe), self-reported invitation to participate, and uptake of DREAMS interventions by: categories and levels of the PEPFAR core package;number of 'primary' interventions (seven in Kenya;five in South Africa). Analyses were stratified by year invited and age at cohort enrolment. RESULTS: Proportions aware and invited to DREAMS increased across all settings, to ≥ 83% aware and ≥ 53% invited by 2018 (highest among AGYW aged 13-17 years, e.g. 63 vs. 40% among 18-22 s, uMkhanyakude). HIV testing, school-based interventions and social protection were the most accessed categories, while differences in uptake by DREAMS invitation were greatest for novel DREAMS interventions, for example, social asset building (76% among those invited in 2017 and 2018 vs. 9% among those never-invited in Nairobi). Although few DREAMS invitees accessed all intended primary interventions by 2019 (2% of 15-17 s and 5% of 18-22 s in Gem), many accessed at least three interventions, including combinations across individual, family and community levels. CONCLUSION: Over time, DREAMS reached high proportions of AGYW in all settings, particularly younger AGYW. Participation in combinations of interventions improved but uptake of the complete primary packages remained low.

The association of exposure to DREAMS on sexually acquiring or transmitting HIV amongst adolescent girls and young women living in rural South Africa.

OBJECTIVE: We investigate how risk of sexually acquiring or transmitting HIV in adolescent girls and young women (AGYW) changed following the real-world implementation of DREAMS (Determined, Resilient, Empowered, AIDS free, Mentored and Safe) HIV prevention programme. DESIGN: A representative population-based prospective cohort study of AGYW living in rural KwaZulu-Natal. METHODS: Between 2017 and 2019, we interviewed a random sample of AGYW aged 13-22 years annually. We measured exposure to DREAMS as self-reported receipt of an invitation to participate and/or participation in DREAMS activities that were provided by DREAMS implementing organizations. HIV and herpes simplex virus type 2 (HSV-2) statuses were ascertained through blood tests on Dried Blood Spot (DBS). We used multivariable regression analysis to assess the association between exposure to DREAMS and risk of acquiring HIV: measured as incident HSV-2 (a proxy of sexual risk) and incident HIV;and the risk of sexually transmitting HIV: measured as being HIV positive with a detectable HIV viral load (≥50 copie/ml) on the last available DBS. We adjusted for sociodemographic, sexual relationship, and migration. RESULTS: Two thousand one hundred and eighty-four (86.4%) of those eligible agreed to participate and 2016 (92.3%) provided data for at least one follow-up time-point. One thousand and thirty (54%) were exposed to DREAMS;HIV and HSV-2 incidence were 2.2/100 person-years [95% confidence interval (CI) 1.66-2.86] and 17.3/100 person-years (95% CI 15.5-19.4), respectively. There was no evidence that HSV-2 and HIV incidence were lower in those exposed to DREAMS: adjusted rate ratio (aRR) 0.96 (95% CI 0.76-1.23 and 0.83 (95% CI 0.46-1.52), respectively. HIV viral load was detectable for 169 (8.9%) respondents;there was no evidence this was lower in those exposed to DREAMS with an adjusted risk difference, compared with those not exposed to DREAMS, of 0.99% (95% CI-1.52 to 3.82]. Participants who lived in peri-urban/ urban setting were more likely to have incident HIV and transmissible HIV. Both HSV-2 incidence and the transmissible HIV were associated with older age and ever having sex. Findings did not differ substantively by respondent age group. CONCLUSION: DREAMS exposure was not associated with measurable reductions in risk of sexually acquiring or transmitting HIV amongst a representative cohort of AGYW in rural South Africa.

DREAMS impact on HIV status knowledge and sexual risk among cohorts of young women in Kenya and South Africa.

OBJECTIVES: We sought evidence of DREAMS' impact on uptake of services and sexual risk among adolescent-girls-and-young-women (AGYW). DESIGN: Cohorts of AGYW aged 13-22 years were randomly selected in 2017-2018 and followed-up to 2019; 1081 in Nairobi, Kenya;1171 in Gem, western Kenya;and 2184 in uMkhanyakude, South Africa. METHODS: Outcomes were knowledge of HIV status, condomless sex (past 12 months), lifetime partners, transactional sex (past 12 months), and awareness and use of condoms and pre-exposure-prophylaxis (PrEP). Using a causal inference framework, we estimated the proportions with each outcome if all vs. none were DREAMS invitees by 2018. RESULTS: Among AGYW followed up in 2019, the percentage invited to DREAMS by 2018 was 74, 57, and 53% in Nairobi, Gem, and uMkhanyakude, respectively. By 2018, the estimated percentages of AGYW who would know their HIV status, comparing the scenarios that all vs. none were DREAMS invitees, were 86 vs. 56% in Nairobi, 80 vs. 68% in Gem, and 56 vs. 49% in uMkhanyakude. By 2019, awareness of condoms and PrEP was high among DREAMS invitees, but recent participation in condom promotion activities was less than 50% and recent PrEP use was around 0-10%. In Gem, there was evidence of a reduction attributable to DREAMS in condomless sex, and among younger AGYW in the number of lifetime partners;in Nairobi evidence of a reduction in condomless sex among sexually active older AGYW;and in uMkhanya-kude no evidence that DREAMS changed these outcomes. CONCLUSION: Alongside sustaining high levels of knowledge of HIV status, more is needed to link AGYW into prevention methods such as PrEP and condoms.Comprehensive HIV prevention promotes safer sexual partnerships, but poverty, social norms, and inequalities limit AGYW's prevention choices.

Isisekelo Sempilo study protocol for the effectiveness of HIV prevention embedded in sexual health with or without peer navigator support (Thetha Nami) to reduce prevalence of transmissible HIV amongst adolescents and young adults in rural KwaZulu-Natal: a 2 × 2 factorial randomised controlled trial.

BACKGROUND: Antiretroviral therapy (ART) through universal test and treat (UTT) and HIV pre-exposure prophylaxis (PrEP) substantially reduces HIV-related mortality, morbidity and incidence. Effective individual-level prevention modalities have not translated into population-level impact in southern Africa due to sub-optimal coverage among adolescents and youth who are hard to engage. We aim to investigate the feasibility, acceptability, and preliminary population level effectiveness of HIV prevention services with or without peer support to reduce prevalence of transmissible HIV amongst adolescents and young adults in KwaZulu-Natal. METHODS: We are conducting a 2 × 2 factorial trial among young men and women aged 16-29 years, randomly selected from the Africa Health Research Institute demographic surveillance area. Participants are randomly allocated to one of four intervention combinations: 1) Standard of Care (SOC): nurse-led services for HIV testing plus ART if positive or PrEP for those eligible and negative; 2) Sexual and Reproductive Health (SRH): Baseline self-collected vaginal and urine samples with study-organized clinic appointments for results, treatment and delivery of HIV testing, ART and PrEP integrated with SRH services; 3) Peer-support: Study referral of participants to a peer navigator to assess their health, social and educational needs and provide risk-informed HIV prevention, including facilitating clinic attendance; or 4) SRH + peer-support. The primary outcomes for effectiveness are: (1) the proportion of individuals with infectious HIV at 12 months and (2) uptake of risk-informed comprehensive HIV prevention services within 60 days of enrolment. At 12 months, all participants will be contacted at home and the study team will collect a dried blood spot for HIV ELISA and HIV viral load testing. DISCUSSION: This trial will enable us to understand the relative importance of SRH and peer support in creating demand for effective and risk informed biomedical HIV prevention and preliminary data on their effectiveness on reducing the prevalence of transmissible HIV amongst all adolescents and youth. TRIAL REGISTRATION: Trial Registry: clincialtrials.gov. CLINICALTRIALS: gov Identifier NCT04532307 . Registered: March 2020.

Impact of the DREAMS Partnership on social support and general self-efficacy among adolescent girls and young women: causal analysis of population-based cohorts in Kenya and South Africa.

INTRODUCTION: The Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS) Partnership aimed to influence psychosocial processes that promote empowerment among adolescent girls and young women (AGYW), and reduce HIV incidence. We estimated the impact of DREAMS on aspects of AGYW's collective and individual agency (specifically, social support and self-efficacy), in three settings where DREAMS was implemented from 2016 until at least end 2018. METHODS: Research cohorts of ~1500 AGYW aged 13-22 were randomly selected from demographic platforms in Kenya (Nairobi; Gem) and South Africa (uMkhanyakude) and followed up from 2017 to 2019. Social support was based on questions about female networks and access to safe places to meet with peers; general self-efficacy was measured using a scale previously validated in other settings. We conducted multivariable logistic regression, and estimated the causal effect of invitation to DREAMS on each outcome in 2018 and 2019 by comparing counter-factual scenarios in which all, vs no, AGYW were DREAMS invitees. RESULTS: In Nairobi, Gem and uMkhanyakude, respectively, 74%, 57% and 53% were invited to DREAMS by 2018. Social support was higher among DREAMS invitees versus non-invitees (eg, adjusted OR 2.0 (95% CI 1.6 to 2.6), Gem, 2018). In 2018, DREAMS increased social support in all settings and age groups, for example, from 28% if none were DREAMS invitees to 43% if all were invitees (+15% (95% CI 10% to 20%)) in Gem. Effects were strongest in Kenya, but weakened in 2019, particularly among older AGYW. In uMkhanyakude, DREAMS invitees had greater self-efficacy compared with non-invitees in 2018 (+9% (95% CI 3% to 13%), 2018) but less so in 2019. In Kenyan settings, there was weak evidence for impact on self-efficacy among younger AGYW in Gem (+6% (95% CI 0% to 13%)) and older AGYW in Nairobi (+9% (95% CI -3% to +20%)) in 2019. CONCLUSIONS: DREAMS impacted on social support and, less consistently, on self-efficacy. Weakening effects over time may reflect changes in access to safe spaces and social networks as AGYW age and change circumstances, and withdrawal of DREAMS from uMkhanyakude in 2018, highlighting the importance of programme sustainability and improving programming for older participants.

Process evaluation of peer-to-peer delivery of HIV self-testing and sexual health information to support HIV prevention among youth in rural KwaZulu-Natal, South Africa: qualitative analysis.

OBJECTIVE: Peer-to-peer (PTP) HIV self-testing (HIVST) distribution models can increase uptake of HIV testing and potentially create demand for HIV treatment and pre-exposure prophylaxis (PrEP). We describe the acceptability and experiences of young women and men participating in a cluster randomised trial of PTP HIVST distribution and antiretroviral/PrEP promotion in rural KwaZulu-Natal. METHODS: Between March and September 2019, 24 pairs of trained peer navigators were randomised to two approaches to distribute HIVST packs (kits+HIV prevention information): incentivised-peer-networks where peer-age friends distributed packs within their social network for a small incentive, or direct distribution where peer navigators distributed HIVST packs directly. Standard-of-care peer navigators distributed information without HIVST kits. For the process evaluation, we conducted semi-structured interviews with purposively sampled young women (n=30) and men (n=15) aged 18-29 years from all arms. Qualitative data were transcribed, translated, coded manually and thematically analysed using an interpretivist approach. RESULTS: Overall, PTP approaches were acceptable and valued by young people. Participants were comfortable sharing sexual health issues they would not share with adults. Coupled with HIVST, peer (friends) support facilitated HIV testing and solidarity for HIV status disclosure and treatment. However, some young people showed limited interest in other sexual health information provided. Some young people were wary of receiving health information from friends perceived as non-professionals while others avoided sharing personal issues with peer navigators from their community. Referral slips and youth-friendly clinics were facilitators to PrEP uptake. Family disapproval, limited information, daily pills and perceived risks were major barriers to PrEP uptake. CONCLUSION: Both professional (peer navigators) and social network (friends) approaches were acceptable methods to receive HIVST and sexual health information. Doubts about the professionalism of friends and overly exclusive focus on HIVST information materials may in part explain why HIVST kits, without peer navigators support, did not create demand for PrEP.

Early impact of the DREAMS partnership on young women's knowledge of their HIV status: causal analysis of population-based surveys in Kenya and South Africa.

BACKGROUND: Knowledge of one's HIV status is the gateway to treatment and prevention, but remains low among young people. We investigated the early impact (2016-2017) of Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS), a multisectoral HIV prevention package, on knowledge of HIV status among adolescent girls and young women (AGYW). METHODS: In 2017, randomly selected AGYW were enrolled into surveys, N=1081 aged 15-22 years in Nairobi slum settlements, and N=2174 aged 13-22 years in rural KwaZulu-Natal. We estimated the causal effect of being a DREAMS beneficiary on knowledge of HIV status (those who self-reported as HIV-positive or tested HIV-negative in the past year), accounting for an AGYW's propensity to be a DREAMS beneficiary. RESULTS: In Nairobi, knowledge of HIV status was higher among DREAMS beneficiaries compared with non-beneficiaries (92% vs 69%, adjusted OR=8.7; 95% CI 5.8 to 12.9), with DREAMS predicted to increase the outcome by 28%, from 65% if none were a DREAMS beneficiary to 93% if all were beneficiaries. The increase attributable to DREAMS was larger among younger participants: 32% and 23% among those aged 15-17 and 18-22 years, respectively. In KwaZulu-Natal, knowledge of status was higher among DREAMS beneficiaries aged 13-17 years (37% vs 26% among non-beneficiaries), with a 9% difference due to DREAMS (95% CI 4.8% to 14.4%), and no evidence of effect among 18-22 years (-2.8%; 95% CI -11.1% to 5.7%). CONCLUSION: DREAMS substantially increased knowledge of HIV status among AGYW in Nairobi, and among younger but not older AGYW in KwaZulu-Natal. Adolescent girls can be reached early (before age 18) with community-based HIV testing programmes in diverse high-prevalence settings, with a large impact on the proportion who know their HIV status.