eYoung men's experiences of violence and poverty and the relationship to sexually transmissible HIV: a cross sectional study from rural South Africa.

Background: Young (ages 18-35 years) men are inadequately engaged in HIV prevention and treatment globally, including in South Africa, increasing the likelihood of them having sexually transmissible HIV (i.e. living with HIV but with high viral loads). We sought to understand how men's experiences of poverty and violence, impacted on transmissible HIV, directly or indirectly via mental health and substance misuse. Setting: Rural communities in northern KwaZulu-Natal, South Africa. Methods: Cross-sectional population-based random selection (September 2018-June 2019), assessing transmissible HIV (living with HIV and viral load ≥400 copies/mL) via dried blood spots, and socio-demographic data. Structural equation models (SEM), assessed direct and indirect pathways from food insecurity and violence experience to transmissible-HIV, with mediators common mental disorders, alcohol use, gender inequitable attitudes and perceptions of life chances. Results: 2,086 young (ages 18-36 years) men and 8.6%(n=178) men had transmissible HIV. In SEM no direct pathways between food insecurity, or violence experience, and transmissible HIV. Poor mental health and alcohol use mediated the relationship between violence experience and food insecurity and transmissible HIV. Life chances also mediated the food insecurity to transmissible HIV pathway. Conclusions: There was a high level of transmissible HIV in a representative sample of young men. The analysis highlights the need to address both the proximate 'drivers' poor mental health and substance misuse, as well as the social contexts shaping these among young men, namely poverty and violence experience. Building holistic interventions that adequately engage these multiple challenges is critical for improving HIV among young men.

Effect of a Male-Targeted Digital Decision Support Application Aimed at Increasing Linkage to HIV Care Among Men: Findings from the HITS Cluster Randomized Clinical Trial in Rural South Africa.

Linkage to HIV care remains suboptimal among men. We investigated the effectiveness of a male-targeted HIV-specific decision support app, Empowering People through Informed Choices for HIV (EPIC-HIV), on increasing linkage to HIV care among men in rural South Africa. Home-Based Intervention to Test and Start (HITS) was a multi-component cluster-randomized controlled trial conducted among 45 communities in uMkhanyakude, KwaZulu-Natal. The development of EPIC-HIV was guided by self-determination theory and human-computer interaction design to increase intrinsic motivation to seek HIV testing and care among men. EPIC-HIV was offered in two stages: EPIC-HIV 1 at the time of home-based HIV counseling and testing (HBHCT), and EPIC-HIV 2 at 1 month after a positive HIV diagnosis if not linked to care. Sixteen communities were randomly assigned to the arms to receive EPIC-HIV, and 29 communities to the arms without EPIC-HIV. Among all eligible men, we compared linkage to care (initiation or resumption of antiretroviral therapy after > 3 months of care interruption) at local clinics within 1 year of a home visit, ascertained from individual clinical records. Intention-to-treat analysis was performed using modified Poisson regression with adjustment for receiving another intervention (i.e., financial incentives) and clustering at the community level. We also conducted a satisfaction survey for EPIC-HIV 2. A total of 13,894 men were eligible (i.e., aged ≥ 15 years and resident in the 45 communities). The mean age was 34.6 (±16.8) years, and 65% were married or in an informal union. Overall, 20.7% received HBHCT, resulting in 122 HIV-positive and 6 discordant tests. Among these, 54 men linked to care within 1 year after HBHCT. Additionally, of the 13,765 eligible participants who did not receive HBHCT or received HIV-negative results, 301 men linked to care within 1 year. Overall, only 13 men received EPIC-HIV 2. The proportion of linkage to care did not differ between the arms randomized to EPIC-HIV and those without EPIC-HIV (adjusted risk ratio = 1.05; 95% CI:0.86-1.29). All 13 men who used EPIC-HIV 2 reported the app was acceptable, user-friendly, and useful for getting information on HIV testing and treatment. The reach was low, although the acceptability and usability of the app were very high among those who engaged with it. Enhanced digital support applications could form part of interventions to increase knowledge of HIV treatment among men. Clinical Trial Number: ClinicalTrials.gov # NCT03757104.

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.

Incident pregnancy and mental health among adolescent girls and young women in rural KwaZulu-Natal, South Africa: an observational cohort study.

Pregnancy can place adolescent girls and young women (AGYW) at risk of poor mental health. However, evidence linking youth pregnancy to mental health in resource-limited settings is limited, especially where HIV incidence is high. We analysed a population-representative cohort of AGYW aged 13-25 in rural KwaZulu-Natal to assess how adolescent pregnancy predicts subsequent mental health. Among 1851 respondents, incident pregnancy (self-reported past-12-month) rose from 0.7% at age 14 to 22.1% by 18. Probable common mental disorder (CMD; 14-item Shona Symptom Questionnaire) prevalence was 19.1%. In adjusted Poisson regression recent pregnancy was associated with slightly higher probable CMD (adjusted prevalence ratio [aPR] 1.19, 95%CI 0.96-1.49), and stronger association among 13-15 year-olds (aPR 3.25, 95%CI 1.50-7.03), but not with HIV serostatus. These findings suggest a possible incremental mental health impact of being pregnant earlier than peers, pointing to the need for age-appropriate mental health interventions for AGYW in resource-limited settings.

Increasing HIV testing and linkage to care among men in rural South Africa using conditional financial incentives and a decision support app: A process evaluation.

Men in sub-Saharan Africa are less likely to accept HIV testing and link to HIV care than women. We conducted a trial to investigate the impact of conditional financial incentives and a decision support application, called EPIC-HIV, on HIV testing and linkage to care. We report the findings of the trial process evaluation to explore whether the interventions were delivered as intended, identify mechanisms of impact and any contextual factors that may have impacted the trial outcomes. Between August 2018 and March 2019, we conducted in-depth interviews and focus group discussions with trial participants (n = 31) and staff (n = 14) to examine views on the implementation process, participant responses to the interventions and the external factors that may have impacted the implementation and outcomes of the study. Interviews were audio-recorded, transcribed, and translated where necessary, and thematically analyzed using ATLAS-ti and NVivo. Both interventions were perceived to be acceptable and useful by participants and implementers. EPIC-HIV proved challenging to implement as intended because it was difficult to ensure consistent use of earphones, and maintenance of privacy. Some participants struggled to navigate the EPIC-HIV app independently and select stories that appealed to them without support. Some participants stopped exploring the app before the end, resulting in an incomplete use of EPIC-HIV. While the financial incentive was implemented as intended, there were challenges with eligibility. The convenience and privacy of home testing influenced the uptake of HIV testing. Contextual barriers including fear of HIV stigma and disclosure if diagnosed with HIV, and expectations of poor treatment in clinics may have inhibited linkage to care. Financial incentives were relatively straightforward to implement and increased uptake of home-based rapid HIV testing but were not sufficient as a 'stand-alone' intervention. Barriers like fear of stigma should be addressed to facilitate linkage to care.

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.

Population impacts of conditional financial incentives and a male-targeted digital decision support application on the HIV treatment cascade in rural KwaZulu Natal: findings from the HITS cluster randomized clinical trial.

INTRODUCTION: In South Africa, the HIV care cascade remains suboptimal. We investigated the impact of small conditional financial incentives (CFIs) and male-targeted HIV-specific decision-support application (EPIC-HIV) on the HIV care cascade. METHODS: In 2018, in uMkhanyakude district, 45 communities were randomly assigned to one of four arms: (i) CFI for home-based HIV testing and linkage to care within 6 weeks (R50 [US$3] food voucher each); (ii) EPIC-HIV which are based on self-determination theory; (iii) both CFI and EPIC-HIV; and (iv) standard of care. EPIC-HIV consisted of two components: EPIC-HIV 1, provided to men through a tablet before home-based HIV testing, and EPIC-HIV 2, offered 1 month later to men who tested positive but had not yet linked to care. Linking HITS trial data to national antiretroviral treatment (ART) programme data and HIV surveillance programme data, we estimated HIV status awareness after the HITS trial implementation, ART status 3 month after the trial and viral load suppression 1 year later. Analysis included all known individuals living with HIV in the study area including those who did not participated in the HITS trial. RESULTS: Among the 33,778 residents in the study area, 2763 men and 7266 women were identified as living with HIV by the end of the intervention period and included in the analysis. After the intervention, awareness of HIV-positive status was higher in the CFI arms compared to non-CFI arms (men: 793/908 [87.3%] vs. 1574/1855 [84.9%], RR = 1.03 [95% CI: 0.99-1.07]; women: 2259/2421 [93.3%] vs. 4439/4845 [91.6%], RR = 1.02 [95% CI: 1.00-1.04]). Three months after the intervention, no differences were found for linkage to ART between arms. One year after the intervention, only 1829 viral test results were retrieved. Viral suppression was higher but not significant in the EPIC-HIV intervention arms among men (65/99 [65.7%] vs. 182/308 [59.1%], RR = 1.11 [95% CI: 0.88-1.40]). CONCLUSIONS: Small CFIs can contribute to achieve the first step of the HIV care cascade. However, neither CFIs nor EPIC-HIV was sufficient to increase the number of people on ART. Additional evidence is needed to confirm the impact of EPIC-HIV on viral suppression.

The impact of a conditional financial incentive on linkage to HIV care: Findings from the HITS cluster randomized clinical trial in rural South Africa.

Introduction: HIV elimination requires innovative approaches to ensure testing and immediate treatment provision. We investigated the effectiveness of conditional financial incentives on increasing linkage to HIV care in a 2×2 factorial cluster randomized controlled trial-Home-Based Intervention to Test and Start (HITS) - in rural South Africa. Methods: Of 45 communities in uMkhanyakude, KwaZulu-Natal, 16 communities were randomly assigned to the arms to receive financial incentives for home-based HIV counseling and testing (HBHCT) and linkage to care within 6 weeks (R50 [US$3] food voucher each) and 29 communities to the arms without financial incentives. We examined linkage to care (i.e., initiation or resumption of antiretroviral therapy after >3 months of care interruption) at local clinics within 6 weeks of a home visit, the eligibility period to receive the second financial incentive. Linkage to care was ascertained from individual clinical records. Intention-to-treat analysis (ITT) was performed using modified Poisson regression with adjustment for receiving another intervention (i.e., male-targeted HIV-specific decision support app) and clustering of standard errors at the community level. Results: Among 13,894 eligible men (i.e., ≥15 years and resident in the 45 communities), 20.7% received HBHCT, which resulted in 122 HIV-positive tests. Of these, 27 linked to care within 6 weeks of HBHCT. Additionally, of eligible men who did not receive HBHCT, 66 linked to care. In the ITT analysis, the proportion of linkage to care among men did not differ in the arms which received financial incentives and those without financial incentives (adjusted Risk Ratio [aRR]=0.78, 95% CI: 0.51-1.21). Among 19,884 eligible women, 29.1% received HBHCT, which resulted in 375 HIV-positive tests. Of these, 75 linked to care. Among eligible women who did not receive HBHCT, 121 linked to care within 6 weeks. Women in the financial incentive arms had a significantly higher probability of linkage to care, compared to those in the arms without financial incentives (aRR=1.50; 95% CI: 1.03-2.21). Conclusion: While a small once-off financial incentive did not increase linkage to care among men during the eligibility period of 6 weeks, it significantly improved linkage to care among women over the same period. Clinical Trial Number: ClinicalTrials.gov # NCT03757104.

Effect of a male-targeted digital decision support application aimed at increasing linkage to HIV care among men: Findings from the HITS cluster randomized clinical trial in rural South Africa.

Introduction: Linkage to HIV care remains suboptimal among men. We investigated the effectiveness of a male-targeted HIV-specific decision support app, Empowering People through Informed Choices for HIV (EPIC-HIV), on increasing linkage to HIV care among men in rural South Africa. Methods: Home-Based Intervention to Test and Start (HITS) was a multi-component cluster-randomized controlled trial among 45 communities in uMkhanyakude, KwaZulu-Natal. The development of EPIC-HIV was guided by self-determination theory and human-centered intervention design to increase intrinsic motivation to seek HIV testing and care among men. EPIC-HIV was offered in two stages: EPIC-HIV 1 at the time of home-based HIV counseling and testing (HBHCT), and EPIC-HIV 2 at 1 month after positive HIV diagnosis. Sixteen communities were randomly assigned to the arms to receive EPIC-HIV, and 29 communities to the arms without EPIC-HIV. Among all eligible men, we compared linkage to care (initiation or resumption of antiretroviral therapy after >3 months of care interruption) at local clinics within 1 year of a home visit, which was ascertained from individual clinical records. Intention-to-treat analysis was performed using modified Poisson regression with adjustment for receiving another intervention (i.e., financial incentives) and clustering at the community level. We also conducted a satisfaction survey for EPIC-HIV 2. Results: Among all 13,894 eligible men (i.e., ≥15 years and resident in the 45 communities), 20.7% received HBHCT, resulting in 122 HIV-positive tests. Among these, 54 men linked to care within 1 year after HBHCT. Additionally, of the 13,765 eligible participants who did not receive HBHCT or received HIV-negative results, 301 men linked to care within 1 year. Overall, only 13 men received EPIC-HIV 2. The proportion of linkage to care did not differ in the arms assigned to EPIC-HIV compared to those without EPIC-HIV (adjusted risk ratio=1.05; 95% CI:0.86-1.29). All 13 men who used EPIC-HIV 2 reported the app was acceptable, user-friendly, and useful for getting information on HIV testing and treatment. Conclusion: Reach was low although acceptability and usability of the app was very high among those who engaged with it. Enhanced digital support applications could form part of interventions to increase knowledge of HIV treatment for men. Clinical Trial Number: ClinicalTrials.gov # NCT03757104.

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.

Adaptation and pre-test of a shortened Stepping Stones and Creating Futures intervention focused on HIV for young men in rural South Africa.

Men's engagement in HIV prevention and treatment is suboptimal, including in South Africa. We sought to address this through adapting an evidence-based intervention, Stepping Stones and Creating Futures (SSCF), to strengthen its HIV content and provide a more scalable (shorter) intervention in rural South Africa. We then conducted a mixed methods pre-test of the intervention among young men aged 18-35 years. To adapt SSCF, we reviewed the current evidence base and worked with male Peer Navigators to update the SSCF theory of change (ToC) and manual. The revised intervention was ~45 hours (9 sessions) as opposed to ~63 hours and included a greater focus on HIV prevention and treatment technologies. Overall, 64% (n = 60) of men approached agreed to participate in the intervention, uptake (attending one session) among those who agreed was n = 35(58%) and retention (attending 6 or more sessions) was n = 25(71%). Qualitative data emphasized the intervention was acceptable, with young men describing it as something they liked. The qualitative data also broadly supported the intervention ToC, including the normalization of HIV in men's lives, and the importance of health for men in achieving their life goals. However, it also highlighted the need to focus more on HIV-related stigma and fear, and the importance of HIV self-testing kits in encouraging testing. We revised the ToC and manual in light of this data. The adapted SSCF is acceptable and supports the ToC. Next steps is an evaluation to look at effectiveness of the intervention.

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 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.

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.

A qualitative investigation of facilitators and barriers to DREAMS uptake among adolescents with grandparent caregivers in rural KwaZulu-Natal, South Africa.

Adolescents with grandparent caregivers have experienced challenges including the death of one or both parents due to HIV in sub-Saharan Africa. They may be left out of existing HIV prevention interventions targeting parents and children. We investigated the facilitators and barriers to DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored and Safe) programme uptake among adolescents with grandparent caregivers across different levels of the socio-ecological model in rural South Africa. Data were collected in three phases (October 2017 to September 2018). Adolescents (13-19 years old) and their grandparent caregivers (≥50 years old) (n = 12) contributed to repeat in-depth interviews to share their perceptions and experiences regarding adolescents' participation in DREAMS. Data were triangulated using key informant interviews with DREAMS intervention facilitators (n = 2) to give insights into their experiences of delivering DREAMS interventions. Written informed consent or child assent was obtained from all individuals before participation. All data were collected in isiZulu and audio-recorded, transcribed verbatim and translated into English. Thematic and dyadic analysis approaches were conducted guided by the socio-ecological model. Participation in DREAMS was most effective when DREAMS messaging reinforced existing norms around sex and sexuality and when the interventions improved care relationships between the adolescents and their older caregivers. DREAMS was less acceptable when it deviated from the norms, raised SRH information that conflicts with abstinence and virginity, and when youth empowerment was perceived as a potential threat to intergenerational power dynamics. While DREAMS was able to engage these complex families, there were failures, about factors uniquely critical to these families, such as in engaging children and carers with disabilities and failure to include adolescent boys in some interventions. There is a need to adapt HIV prevention interventions to tackle care relationships specific to adolescent-grandparent caregiver communication.

Antiretroviral therapy based HIV prevention targeting young women who sell sex: a mixed method approach to understand the implementation of PrEP in a rural area of KwaZulu-Natal, South Africa.

Pre-Exposure Prophylaxis (PrEP) is a potential game-changer for HIV. We used PrEP introduction for Young Women Who Sell Sex (YWSS) in a rural South Africa district to understand community norms and PrEP coverage in YWSS. Between 2017 and 2018, we measured awareness and uptake of PrEP in a representative cohort of 2184 Adolescent Girls and Young Women (AGYW) aged 13-22. We conducted group discussions with young people and community members (19); key informant interviews (9), in-depth interviews with 15-24 year-olds (58) and providers (33). Interviews were analysed using thematic analysis. PrEP awareness increased from 2% to 9%. Among 965 AGYW sexually-active by 2018, 13.4% (95%CI: 11.4%-15.7%) reported transactional sex and 10.6% (95%CI: 8.85-12.7%) sex for money. Of the 194 YWSS, 21 were aware of PrEP, but none had used it. Youth were enthusiastic about PrEP as tool for HIV prevention; whilst older community members were cautious about a technology they had limited experience with but could benefit select groups. Teachers and healthcare providers were concerned that PrEP would lower personal responsibility for sexual health. In conclusion, the narrow and limited introduction of PrEP to YWSS reduced the accessibility and reach. Introducing PrEP as part of sexual healthcare may improve demand and access for YWSS.