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.

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.

How do new crises impact HIV risk behaviour - exploring HIV risk behaviour according to COVID-19-related orphanhood status in South Africa?

ABSTRACTThe COVID-19 pandemic resulted in high death rates globally, and over 10.5 million children lost a parent or primary caregiver. Because HIV-related orphanhood has been associated with elevated HIV risk, we sought to examine HIV risk in children affected by COVID-19 orphanhood. Four hundred and twenty-one children and adolescents were interviewed, measuring seven HIV risk behaviours: condom use, age-disparate sex, transactional sex, multiple partners, sex associated with drugs/alcohol, mental health and social risks. Approximately 50% (211/421) experienced orphanhood due to COVID-19, 4.8% (20/421) reported living in an HIV-affected household, and 48.2% (203/421) did not know the HIV status of their household. The mean age of the sample was 12.7 years (SD:2.30), of whom 1.2% (5/421) were living with HIV. Eighty percent (337/421) reported at least one HIV risk behaviour. HIV sexual risk behaviours were more common among children living in HIV-affected households compared to those not living in HIV-affected households and those with unknown household status (35.0% vs. 13.6% vs.10.8%, X2 = 9.25, p = 0.01). Children living in HIV-affected households had poorer mental health and elevated substance use (70.0% vs. 48.5%, X2 = 6.21, p = 0.05; 35.0% vs. 19.9%, X2 = 4.02, p = 0.1306, respectively). HIV-affected households may require specific interventions to support the health and well-being of children and adolescents.

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.

Healthcare provisions associated with multiple HIV-related outcomes among adolescent girls and young women living with HIV in South Africa: a cross-sectional study.

INTRODUCTION: Adolescent girls and young women (AGYW) living with HIV experience poor HIV outcomes and high rates of unintended pregnancy. Little is known about which healthcare provisions can optimize their HIV-related outcomes, particularly among AGYW mothers. METHODS: Eligible 12- to 24-year-old AGYW living with HIV from 61 health facilities in a South African district completed a survey in 2018-2019 (90% recruited). Analysing surveys and medical records from n = 774 participants, we investigated associations of multiple HIV-related outcomes (past-week adherence, consistent clinic attendance, uninterrupted treatment, no tuberculosis [TB] and viral suppression) with seven healthcare provisions: no antiretroviral therapy (ART) stockouts, kind and respectful providers, support groups, short travel time, short waiting time, confidentiality, and safe and affordable facilities. Further, we compared HIV-related outcomes and healthcare provisions between mothers (n = 336) and nulliparous participants (n = 438). Analyses used multivariable regression models, accounting for multiple outcomes. RESULTS: HIV-related outcomes were poor, especially among mothers. In multivariable analyses, two healthcare provisions were "accelerators," associated with multiple improved outcomes, with similar results among mothers. Safe and affordable facilities, and kind and respectful staff were associated with higher predicted probabilities of HIV-related outcomes (p<0.001): past-week adherence (62% when neither accelerator was reported to 87% with both accelerators reported), clinic attendance (71%-89%), uninterrupted ART treatment (57%-85%), no TB symptoms (49%-70%) and viral suppression (60%-77%). CONCLUSIONS: Accessible and adolescent-responsive healthcare is critical to improving HIV-related outcomes, reducing morbidity, mortality and onward HIV transmission among AGYW. Combining these provisions can maximize benefits, especially for AGYW mothers.

A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial.

BACKGROUND: Evidence-based parenting programmes have strong evidence in preventing and mitigating violence, but in-person programmes are challenging to deliver at scale. ParentApp is an open-source, offline-first app-based adaptation of the Parenting for Lifelong Health for Parents and Teens programme to promote playful and positive parenting, reduce risks for sexual violence victimisation, and prevent violence against adolescents. This study aims to evaluate the effectiveness and cost-effectiveness of ParentApp compared to an attention-control group. METHODS: This study is a two-arm pragmatic cluster-randomised controlled trial to test whether ParentApp reduces adolescent physical abuse, emotional abuse, and sexual violence risks and victimisation at 1 month and 12 months post-intervention. Caregivers of adolescents aged 10-17 years and their adolescent children (N = 2400 caregiver-adolescent dyads) will be recruited in urban and peri-urban communities in the Mwanza region of Tanzania. A total of 80 study clusters will be stratified and randomised (1:1) to the intervention group, who will receive ParentApp with support through a WhatsApp group, or to an attention-control group, who will receive a water, sanitation, and hygiene app. Quantitative data will be collected through outcomes questionnaires with caregivers and adolescents, administered at baseline, 4 months post-baseline, and 16 months post-baseline, as well as through routine implementation data and ParentApp engagement data. Qualitative data will be collected through individual interviews and focus groups with caregivers, adolescents, and implementing partner staff. DISCUSSION: App-based interventions have the potential to expand access to evidence-based parenting support, but currently lack rigorous evidence in low- and middle-income countries. This is the first known randomised control trial of a hybrid digital parenting programme to prevent the abuse of adolescents in low- and middle-income settings. TRIAL REGISTRATION: The trial was registered on the Open Science Framework on 14 March 2023, registration: OSF.IO/T9FXZ .

Identifying Adolescents at Highest Risk of ART Non-adherence, Using the World Health Organization-Endorsed HEADSS and HEADSS+ Checklists.

Brief tools are necessary to identify adolescents at greatest risk for ART non-adherence. From the WHO's HEADSS/HEADSS+ adolescent wellbeing checklists, we identify constructs strongly associated with non-adherence (validated with viral load). We conducted interviews and collected clinical records from a 3-year cohort of 1046 adolescents living with HIV from 52 South African government facilities. We used least absolute shrinkage and selection operator variable selection approach with a generalized linear mixed model. HEADSS constructs most predictive were: violence exposure (aOR 1.97, CI 1.61; 2.42, p < 0.001), depression (aOR 1.71, CI 1.42; 2.07, p < 0.001) and being sexually active (aOR 1.80, CI 1.41; 2.28, p < 0.001). Risk of non-adherence rose from 20.4% with none, to 55.6% with all three. HEADSS+ constructs were: medication side effects (aOR 2.27, CI 1.82; 2.81, p < 0.001), low social support (aOR 1.97, CI 1.60; 2.43, p < 0.001) and non-disclosure to parents (aOR 2.53, CI 1.91; 3.53, p < 0.001). Risk of non-adherence rose from 21.6% with none, to 71.8% with all three. Screening within established checklists can improve identification of adolescents needing increased support. Adolescent HIV services need to include side-effect management, violence prevention, mental health and sexual and reproductive health.

Associations of formal childcare use with health and human capital development for adolescent mothers and their children in South Africa: A cross-sectional study.

AIM: This study aims to investigate associations of formal childcare with maternal and child outcomes in a large sample of adolescent mothers. BACKGROUND: Forty percent of adolescent girls in Africa are mothers. Increasing evidence shows positive impacts of formal childcare use for adult women, but no known studies in the Global South examine associations for adolescent mothers and their children. METHODS: We interviewed 1046 adolescent mothers and completed developmental assessments with their children (n = 1139) in South Africa's Eastern Cape between 2017 and 2019. Questionnaires measured childcare use, maternal and child outcomes and socio-demographic background variables. Using cross-sectional data, associations between formal childcare use and outcomes were estimated in multivariate multi-level analyses that accounted for individual-level and family-level clustering. RESULTS: Childcare use was associated with higher odds of being in education or employment (AOR: 4.01, 95% CIs: 2.59-6.21, p < .001), grade promotion (AOR: 2.08, 95% CIs: 1.42-3.05, p < .001) and positive future ideation (AOR: 1.58, 95% CIs: 1.01-2.49, p = .047) but no differences in mental health. Childcare use was also associated with better parenting on all measures: positive parenting (AOR: 1.66, 95% CIs: 1.16-2.38, p = .006), better parental limit-setting (AOR: 2.00, 95% CIs: 1.37-2.93, p < .001) and better positive discipline (AOR: 1.77, 95% CIs: 1.21-2.59, p = .003). For the children, there were no differences in temperament or illness, but a significant interaction showed stronger associations between childcare use and better cognitive, language and motor scores with increasing child age (AOR: 5.04, 95% CIs: 1.59-15.96, p = .006). CONCLUSIONS: Adolescent mothers might benefit substantially from formal childcare, but causal links need to be explored further. Childcare use was also associated with improved parenting and better child development over time, suggesting positive pathways for children. At an average of $9 per month, childcare provisions for adolescent mothers may offer low-cost opportunities to achieve high returns on health and human capital outcomes in Sub-Saharan African contexts.

Whole of government approaches to accelerate adolescent success: efficiency and financing considerations.

The multiple domains of development covered by the Sustainable Development Goals (SDGs) present a practical challenge for governments. This is particularly acute in highly resource-constrained settings which use a sector-by-sector approach to structure financing and prioritization. One potentially under-prioritized solution is to implement interventions with the potential to simultaneously improve multiple outcomes across sectors, what United Nations Development Programme refer to as development 'accelerators'. An increasing number of accelerators are being identified in the literature. There are, however, challenges associated with the evaluation and implementation of accelerators. First, as accelerators have multiple benefits, possibly in different sectors, they will be undervalued if the priority setting is conducted sector-by-sector. Second, even if their value is recognized, accelerators may not be adopted if doing so clashes with any of the multiple competing interests policymakers consider, of which efficiency/social desirability is but one. To illustrate the first challenge, and outline a possible solution, we conduct a cost-effectiveness analysis comparing the implementation of three sector-specific interventions to an accelerator, first using a sector-by-sector planning perspective, then a whole of government approach. The case study demonstrates how evaluating the cost-effectiveness of interventions sector-by-sector can lead to suboptimal efficiency rankings and overlook interventions that are efficient from a whole of government perspective. We then examine why recommendations based on a whole of government approach to evaluation are unlikely to be heeded. To overcome this second challenge, we outline a menu of existing and novel financing mechanisms that aim to address the mismatch between political incentives and logistical constraints in the priority setting and the economic evaluation evidence for cost-effective accelerators. These approaches to financing accelerators have the potential to improve efficiency, and in doing so, progress towards the SDGs, by aligning political incentives more closely with recommendations based on efficiency rankings.

A community-based child health and parenting intervention to improve child HIV testing, health, and development in rural Lesotho (Early Morning Star): a cluster-randomised, controlled trial.

BACKGROUND: When caregivers live in remote settings characterised by extreme poverty, poor access to health services, and high rates of HIV/AIDS, their caregiving ability and children's development might be compromised. We aimed to test the effectiveness of a community-based child health and parenting intervention to improve child HIV testing, health, and development in rural Lesotho. METHODS: We implemented a matched cluster-randomised, controlled trial in the Mokhotlong district in northeastern Lesotho with 34 community clusters randomly assigned to intervention or wait-list control groups within a pair. Eligible clusters were villages with non-governmental organisation partner presence and an active preschool. Participants were caregiver-child dyads, where the child was 12-60 months old at baseline. The intervention consisted of eight group sessions delivered at informal preschools to all children in each village. Mobile health events were hosted for all intervention (n=17) and control (n=17) clusters, offering HIV testing and other health services to all community members. Primary outcomes were caregiver-reported child HIV testing, child language development, and child attention. Assessments were done at baseline, immediately post-intervention (3 months post-baseline), and 12 months post-intervention. We assessed child language by means of one caregiver-report measure (MacArthur-Bates Communicative Development Inventory [CDI]) and used two observational assessments of receptive language (the Mullen Scales of Early Learning receptive language subscale, and the Peabody Picture Vocabulary Test 4th edn). Child attention was assessed by means of the Early Childhood Vigilance Task. Assessors were masked to group assignment. Analysis was by intention to treat. This trial was registered with ISRCTN.com, ISRCTN16654287 and is completed. FINDINGS: Between Aug 8, 2015, and Dec 10, 2017, 1040 children (531 intervention; 509 control) and their caregivers were enrolled in 34 clusters (17 intervention; 17 control). Compared with controls, the intervention group reported significantly higher child HIV testing at the 12-month follow-up (relative risk [RR] 1·46, 95% CI 1·29 to 1·65, p<0·0001), but not immediately post-intervention. The intervention group showed significantly higher child receptive language on the caregiver report (CDI) at immediate (effect size 3·79, 95% CI 0·78 to 6·79, p=0·028) but not at 12-month follow-up (effect size 2·96, 95% CI -0·10 to 5·98, p=0·056). There were no significant group differences for the direct assessments of receptive language. Child expressive language and child attention did not differ significantly between groups. INTERPRETATION: Integrated child health and parenting interventions, delivered by trained and supervised lay health workers, can improve both child HIV testing and child development. FUNDING: United States Agency for International Development (USAID) and the President's Emergency Plan for AIDS Relief (PEPFAR).

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.

Key normative, legal, and policy considerations for supporting pregnant and postpartum adolescents in high HIV-burden settings: a critical analysis.

Rates of adolescent pregnancy within sub-Saharan Africa are increasing. Adolescent mothers ages 10-19 years face a distinct set of risks to their own and their children's health, compounded by many economic, social, and epidemiological challenges, such as living with HIV. In navigating this complex developmental period, many adolescent mothers face structural barriers impeding safe transitions to adulthood and motherhood. Drawing on existing literature and emerging data, we outline three normative, legal, and policy issues - violence and gender inequity, access to sexual and reproductive health services, and access to social and structural supports - which affect the health, wellbeing and development of adolescent mothers and their children. We also highlight emergent evidence about programming and policy changes that can better support adolescent mothers and their children. These key proposed responses include removing barriers to SRH and HIV service integration; ensuring implementation of return-to-school policies; and extending social protection systems to cater for adolescent mothers. Despite ongoing global crises and shifts in funding priorities, these normative, legal, and policy considerations remain critical to safeguard the health and wellbeing of adolescent mothers and their children.

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.

Protocol for the OCAY study: a cohort study of orphanhood and caregiver loss in the COVID-19 era to explore the impact on children and adolescents.

INTRODUCTION: Globally, no person has been untouched by the COVID-19 pandemic. Yet, little attention has been given to children and adolescents in policy, provision and services. Moreover, there is a dearth of knowledge regarding the impact of COVID-19-associated orphanhood and caregiver loss on children. This study aims to provide early insights into the mental health and well-being of children and adolescents experiencing orphanhood or caregiver loss in South Africa. METHODS AND ANALYSIS: Data will be drawn from a quantitative longitudinal study in Cape Town, South Africa. A sample of children and adolescents between the ages of 9 and 18 years, experiencing parental or caregiver loss from COVID-19, will be recruited together with a comparison group of children in similar environments who did not experience loss. The study aims to recruit 500 children in both groups. Mental health and well-being among children will be explored through the use of validated and study-specific measures. Participants will be interviewed at two time points, with follow-up data being collected 12-18 months after baseline. A combination of analytical techniques (including descriptive statistics, regression modelling and structural equation modelling) will be used to understand the experience and inform future policy and service provision. ETHICS AND DISSEMINATION: This study received ethical approval from the Health Research Ethics Committee at Stellenbosch University (N 22/04/040). Results will be disseminated via academic and policy publications, as well as national and international presentations including high-level meetings with technical experts. Findings will also be disseminated at a community level via various platforms.

Parenting in Adversity: Effects of Older Caregivers, Biological Carers and Troubled Carers on Child Outcomes in High HIV-Affected Communities.

Caregiving by older adults is a common phenomenon, enhanced in the era of HIV infection. This longitudinal study was set up to examine the effect of caregiver age, relationship and mental wellbeing on child (4-13 years) outcomes (psychosocial and cognitive) in a sample of 808 caregiver- child dyads in South Africa and Malawi. Respondents were drawn from consecutive attenders at Community Based Organisations (CBOs) and interviewed with standardised inventories at baseline and followed up 12-15 months later. Analysis focused on three separate aspects of the caregiver; age, relationship to the child, and mental wellbeing, results are stratified with regard to these factors. Results showed that compared to younger caregivers, over 50 years were carrying a heavy load of childcare, but caregiver age for the most part was not associated with child outcomes. Being biologically related to the child (such as biological grandparenting) was also not a significant factor in child outcomes measured. However, irrespective of age and relationship, caregiver mental health was associated with differences in child outcome - those children of caregivers with a greater mental health burden were found to report experiencing more physical and psychologically violent discipline. Over time, the use of violent discipline was found to reduce. These data suggest that older caregivers and grandparents are providing comparable care to younger caregivers, for young children in the face of the HIV epidemic and that interventions should focus on mental health support for all caregivers, irrespective of age or relationship to the child.

A conceptual framework and exploratory model for health and social intervention acceptability among African adolescents and youth.

Intervention acceptability has become an increasingly key consideration in the development, evaluation and implementation of health and social interventions. However, to date this area of investigation has been constrained by the absence of a consistent definition of acceptability, comprehensive conceptual frameworks disaggregating its components, and few reliable assessment measures. This paper aims to contribute to this gap, by proposing a conceptual framework and exploratory model for acceptability with a specific priority population for health and developmental interventions: adolescents and youth in Africa. We document our multi-staged approach to model development, comprising both inductive and deductive components, and both systematic and interpretative review methods. This included thematic analyses of respective acceptability definitions and findings, from 55 studies assessing acceptability of 60 interventions conducted with young people aged 10-24 in (mainly Southern and Eastern) Africa over a decade; a consideration of these findings in relation to Sekhon et al.'s Theoretical Framework of Acceptability (TFA); a cross-disciplinary review of acceptability definitions and models; a review of key health behavioural change models; and expert consultation with interdisciplinary researchers. Our proposed framework incorporates nine component constructs: affective attitude, intervention understanding, perceived positive effects, relevance, perceived social acceptability, burden, ethicality, perceived negative effects and self-efficacy. We discuss the rationale for the inclusion and definition of each component, highlighting key behavioural models that adopt similar constructs. We then extend this framework to develop an exploratory model for acceptability with young people, that links the framework components to each other and to intervention engagement. Acceptability is represented as an emergent property of a complex, adaptive system of interacting components, which can influence user engagement directly and indirectly, and in turn be influenced by user engagement. We discuss opportunities for applying and further refining or developing these models, and their value as a point of reference for the development of acceptability assessment tools.

Does pre-COVID impulsive behaviour predict adherence to hygiene and social distancing measures in youths following the COVID-19 pandemic onset? Evidence from a South African longitudinal study.

BACKGROUND: Engagement in protective behaviours relating to the COVID-19 pandemic has been proposed to be key to infection control. This is particularly the case for youths as key drivers of infections. A range of factors influencing adherence have been identified, including impulsivity and risk taking. We assessed the association between pre-COVID impulsivity levels and engagement in preventative measures during the COVID-19 pandemic in a longitudinal South African sample, in order to inform future pandemic planning. METHODS: Data were collected from N = 214 youths (mean age at baseline: M = 17.81 (SD = .71), 55.6% female) living in a South African peri-urban settlement characterised by high poverty and deprivation. Baseline assessments were taken in 2018/19 and the COVID follow-up was conducted in June-October 2020 via remote data collection. Impulsivity was assessed using the Balloon Analogue Task (BART), while hygiene and social distancing behaviours were captured through self-report. Stepwise hierarchical regression analyses were performed to estimate effects of impulsivity on measure adherence. RESULTS: Self-rated engagement in hygiene behaviours was high (67.1-86.1% "most of the time", except for "coughing/sneezing into one's elbow" at 33.3%), while engagement in social distancing behaviours varied (22.4-57.8% "most of the time"). Higher impulsivity predicted lower levels of hygiene (ß = .14, p = .041) but not social distancing behaviours (ß = -.02, p = .82). This association was retained when controlling for a range of demographic and COVID-related factors (ß = .14, p = .047) and was slightly reduced when including the effects of a life-skills interventions on hygiene behaviour (ß = -.13, p = .073). CONCLUSIONS: Our data indicate that impulsivity may predict adolescent engagement in hygiene behaviours post COVID-19 pandemic onset in a high risk, sub-Saharan African setting, albeit with a small effect size. For future pandemics, it is important to understand predictors of engagement, particularly in the context of adversity, where adherence may be challenging. Limitations include a small sample size and potential measure shortcomings.