A prospective randomised controlled trial investigating household SARS-CoV-2 transmission in a densely populated community in Cape Town, South Africa - the transmission of COVID-19 in crowded environments (TRACE) study.

BACKGROUND: South Africa's first SARS-CoV-2 case was identified 5th March 2020 and national lockdown followed March 26th. Households are an important location for secondary SARS-CoV-2 infection. Physical distancing and sanitation - infection mitigation recommended by the World Health Organization (WHO) at the time - are difficult to implement in limited-resource settings because of overcrowded living conditions. METHODS: This study (ClinicalTrials.gov NCT05119348) was conducted from August 2020 to September 2021 in two densely populated, low socioeconomic Cape Town community sub-districts. New COVID-19 index cases (ICs) identified at public clinics were randomised to an infection mitigation intervention (STOPCOV) delivered by lay community health workers (CHWs) or standard of care group. STOPCOV mitigation measures included one initial household assessment conducted by a CHW in which face masks, sanitiser, bleach and written information on managing and preventing spread were provided. This was followed by regular telephonic follow-up from CHWs. SARS-CoV-2 PCR and IgM/IgG serology was performed at baseline, weeks 1, 2, 3 and 4 of follow-up. RESULTS: The study randomised 81 ICs with 245 HHCs. At baseline, no HHCs in the control and 7 (5%) in the intervention group had prevalent SARS-CoV-2. The secondary infection rate (SIR) based on SARS-CoV-2 PCR testing was 1.9% (n = 2) in control and 2.9% (n = 4) in intervention HHCs (p = 0.598). At baseline, SARS-CoV-2 antibodies were present in 15% (16/108) of control and 38% (52/137) of intervention participants. At study end incidence was 8.3% (9/108) and 8.03% (11/137) in the intervention and control groups respectively. Antibodies were present in 23% (25/108) of control HHCs over the course of the study vs. 46% (63/137) in the intervention arm. CHWs made twelve clinic and 47 food parcel referrals for individuals in intervention households in need. DISCUSSION: Participants had significant exposure to SARS-CoV-2 infections prior to the study. In this setting, household transmission mitigation was ineffective. However, CHWs may have facilitated other important healthcare and social referrals.

Scaling up pre-exposure prophylaxis in sub-Saharan Africa.

PURPOSE OF REVIEW: Pre-exposure prophylaxis (PrEP) is highly efficacious for preventing HIV. Demonstrations worldwide show growing acceptability with nonoral formulations in the pipeline. Despite these successes, oral PrEP scale-up in sub-Saharan Africa (SSA), the region hardest hit by HIV, remains sub-optimal. This review details emerging practises and addresses challenges in PrEP scale-up and delivery within SSA. RECENT FINDINGS: PrEP scale-up varies across SSA. Some countries face implementation challenges, whereas most have not applied for or received regulatory approval. As governments balance treatment and prevention costs, PrEP advocacy is growing. Demand has been slow, because of low-risk perception, HIV treatment conflation or poor information. Challenges in SSA are markedly different than elsewhere, as delivery is targeted to generalized heterosexuals, rather than only key populations. SSA requires public sector engagement and innovative delivery platforms. SUMMARY: PrEP scale-up in SSA is sub-optimal, hindered by regulatory processes, implementation challenges, poor community engagement and inadequate funding. Approaches that acknowledge overburdened, under-resourced health sectors, and seek opportunities to integrate, task-shift, decentralize and even de-medicalize, with a tailored approach, while campaigning to educate and stimulate demand are most likely to work. Solutions to oral PrEP scale-up will apply to other formulations, opening new avenues for ARV (microbicides and injectables) and non-ARV-based (future vaccine) biomedical prevention provision.

Realising agency: insights from participatory research with learners in a South African sexual and reproductive health programme.

Background: Investing in the capabilities of adolescents is essential to achieving the United Nations Sustainable Development Goals, which focus on realising adolescent girls and young women's (AGYW) rights to education, health, bodily autonomy and integrity, sexual and reproductive health (SRH) and well-being. Despite significant scientific and programmatic progress in understanding and responding to their unique and intersecting vulnerabilities, AGYW continue to face disproportionate risk of STIs, HIV and early pregnancy. Health promotion and preventative interventions stand to be improved by early and meaningful engagement of AGYW in intervention design and delivery. Methods: This study employed Youth Participatory Action Research (YPAR) to co-generate lessons for future school-based SRH programming. The 5-step YPAR process included: (1) youth investigator recruitment; (2) youth investigator training and co-design of YPAR methods; (3) youth investigator-led data collection; (4) collaborative analysis and interpretation; and (5) dissemination. Results: Collaborative analysis revealed improvements in self-concept and bodily autonomy, understanding and formation of healthy relationships and demand for girl-centred health services and information at school. Additionally, the study highlights YPAR's positive influence on both the collaborative process and outputs of research. Further, it provides further insight into the quantitative biomedical and socio-behavioural findings of a larger experimental impact evaluation, in which it was nested. Conclusion: Results from YPAR methods point to high programme acceptability and practical lessons to inform future school-based SRH programming. The inclusion of adolescent girls in the design, delivery and evaluation of intervention research that affects their lives is an important strategy for improving acceptability, and also has demonstrated value in building their health and social assets. Future recommendations include parental involvement, and employing quantitative measures for better evaluation of youth engagement, leadership and partnerships in the research process.

Interrogating the promise of long-acting HIV pre-exposure prophylaxis.

Oral HIV pre-exposure prophylaxis (PrEP) is a well-established product that provides a safe and highly effective way for individuals to protect themselves against HIV infection. However, hopes of a significant reduction in HIV incidence have been disappointing because of low uptake, adherence challenges to a daily pill regimen, and consistently high discontinuation rates within 6 months of initiation. Long-acting agents have been long awaited for their potential to facilitate adherence and to offer a choice between PrEP products. As the first long-acting agents enter the market, with more poised to follow, questions around how to integrate long-acting agents into oral PrEP platforms, and what the potential advantages and pitfalls of this integration will be, now need to be considered.

Promises and potential pitfalls of long-acting injectable pre-exposure prophylaxis.

The number of products that can provide pre-exposure prophylaxis (PrEP) for HIV prevention is expanding, with three now approved in South Africa (oral Tenofovir-based PrEP, injectable Cabotegravir, and a Dapivirine-based vaginal ring) and more in the development pipeline. Although highly effective and safe, oral PrEP products have not reduced HIV incidence in South Africa to the extent seen in other countries, primarily due to adherence challenges, rapidly diminishing persistence over time, and insufficient scale-up of PrEP service delivery. The Dapivirine vaginal ring, which provides 1-month-long protection, provides women with a new and discreet choice for PrEP; however, it is Cabotegravir long-acting (CAB LA) that is anticipated to land the largest impact. Administered as an intramuscular injection given every 2 months, CAB LA is safe, highly efficacious, and expected to become available in South Africa in late 2023. Yet, clinical and implementation questions remain, including the need to understand and characterise breakthrough HIV infections amongst CAB LA users, knowledge of how to package each PrEP product in a new context of PrEP choice, and how to avoid the remedicalisation of PrEP access following extensive efforts to make oral PrEP delivery differentiated and community based.

School-based healthcare services in Cape Town, South Africa: When there's a will, there's a way.

South African secondary schools do not deliver school-based healthcare services despite high rates of human immunodeficiency virus (HIV) infection, sexually transmitted infections, and unplanned pregnancies among adolescents, ongoing sub-optimal uptake of healthcare services from public healthcare facilities by adolescents, and national policy support for such services. A pilot school health nursing programme (SHNP) was offered to 44 secondary schools in a single health sub-district within the Western Cape, South Africa. The programme included fortnightly nurse visits that offered a standard package of healthcare services, including sexual and reproductive health services tailored according to school preference.Of the 44 schools, 42 gave permission for the SHNP to operate, with the majority of schools selecting the full comprehensive package of services. Programme implementation was truncated such that delivery only occurred over two school terms (20 weeks); however, 344 students attended the service. The majority of service users were female with a median age of 16 years, and over a half attended the service for sexual and reproductive health services.Contribution: A key challenge to school-based health service delivery arose from inadequate stakeholder support and differential views of adolescent healthcare needs among government officials, parents, guardians, school staff and governing bodies. These findings motivate for ongoing multi-level stakeholder engagement around the reality of adolescent healthcare needs and further opportunities to deliver school health services for longer time periods such that their feasibility, acceptability, and potential to impact healthcare outcomes can be assessed in this setting.

Lessons Learned From the Implementation of a School-Based Sexual Health Education Program for Adolescent Girls in Cape Town, South Africa.

Comprehensive sexual education (CSE) is an important approach for health promotion dissemination in schools, particularly when delivered in participatory ways that are sport based, peer or near-peer led, and include concepts of gender and power dynamics. Sufficient attendance at CSE sessions is critical to ensure content exposure and build potential for impact. This article details implementation lessons from the delivery of an after-school, near-peer-led CSE program called SKILLZ during a cluster randomized controlled trial among 40 secondary schools in Cape Town, South Africa. SKILLZ is an evidence-based program previously implemented in similar contexts. Attendance in this study was suboptimal (less than 50%) despite qualitative indications of high acceptability and extensive efforts to adapt implementation and boost attendance. Qualitative and quantitative data gathered during anonymous surveys, in-depth interviews, and focus group discussions with participants with high and low attendance records, near-peer coaches, and school staff from both cohorts indicated that poor attendance could be attributed to several factors. Program adaptations, such as delivering difficult-to-access health services before participants attended the SKILLZ program rather than after, may have reduced the incentive for young people to attend the program. Practical barriers to attendance were identified, including security concerns, competing priorities, and unfamiliarity with after-school programming culture in this setting. Community engagement and acceptability of sexual education programs for adolescents alone may be insufficient to ensure program uptake and engagement.

HIV prevention: better choice for better coverage.

INTRODUCTION: Antiretroviral-based pre-exposure prophylaxis (PrEP) is today an established, effective and safe method of HIV prevention used in multiple countries worldwide by a broad range of populations at risk of HIV infection. Biomedical innovations are critical in supporting the primary prevention of HIV; however, their potential can only be maximized if end-user challenges are recognized, described and used to develop next-generation models. DISCUSSION: First-generation PrEP, a daily oral pill, is highly efficacious, discreet and affords users the ability to commence and conclude treatment rapidly. However, consistent daily adherence and persistence is challenging, especially among younger populations, due in part to side effects, the risk of stock-outs and a lack of pill storage options. Second-generation PrEP, longer acting agents that require less frequent dosing, could overcome such challenges. Agents that have shown efficacy in clinical trials include a monthly vaginal ring and PrEP injectables to be administered every 8 weeks, while products in development include 6 monthly injectables, oral therapy that uses monthly rather than daily pills, implants and the potential for long-acting passive immunization. CONCLUSIONS: Second-generation PrEP agents will have the potential to offer improved adherence and less frequent reminders once they have undergone further development and the delivery systems that will best support them have been established. In order to pursue global UNAIDS targets of reducing new HIV infections to fewer than 500,000 annually by 2025, and to ensure that all people have access to prevention options that meet their specific prevention needs, both early and next-generation PrEP options are needed.

A cost analysis of a sports-based sexual health education programme for adolescent girls in South African schools.

Studies have shown that school-based sexual health promotion interventions can improve adolescent sexual and reproductive health outcomes. However, there has been insufficient evidence on the cost and cost-effectiveness of such programmes, driving poor and inconsistent investment and prioritization. This paper analyses the costs of the SKILLZ Health for Girls programme, a sports-based sexual education intervention targeted at adolescent girls in the secondary school environment. Costs were collected alongside a cluster-randomized trial, including 38 secondary schools in Cape Town, South Africa. The analysis was conducted from a provider (multi-sector) perspective and used a mixed-methods costing approach. We developed a cost data collection tool to compile cost information from one-on-one interviews, administrative data and non-participant observations of the intervention. Costs were analysed for 2019, representing a full academic year of programme implementation. The intention-to-treat analysis revealed an average cost per learner per session of $9.92, and the cost per learner reached was estimated at $69.43. Sensitivity analysis indicated that these costs were sensitive to the participation rates of the learners who did not complete the intervention. The cumulative cost for the scale-up scenario for the Western Cape Province based on the base-case analysis (maximizing coverage of schools but only including 30% of eligible learners within schools) was estimated at $5 311 453.00 for a 3-year period, which exceeds the provincial conditional grant allocation dedicated to the human immunodeficiency virus and acquired immune deficiency syndrome (life skills education) for the same period, yet is comparable to the expenditure for a similar donor-funded programme within the province. The study's results will contribute to decision-making for implementing sexual education interventions in schools in South Africa and similar contexts.

Women of Worth: the impact of a cash plus intervention to enhance attendance and reduce sexual health risks for young women in Cape Town, South Africa.

INTRODUCTION: Conditional cash transfers (CTs) augmented with other interventions are promising interventions for reducing HIV risk in adolescent girls and young women. METHODS: A multi-phase, quasi-experimental study assessed the impact of a CT (ZAR300; $22) conditional on attending a skills building intervention, Women of Worth (WoW), designed to improve sexual and reproductive health (SRH) outcomes in Cape Town, South Africa from May 2017 to December 2019. The intervention entailed 12 sessions with encouragement to attend adolescent and youth-friendly health services. Women aged 19-24 years were randomized 1:1 to receive the intervention with a CT ("cash + care" or C+C) or without a CT ("care"). The study included a pilot phase followed by a post-modification phase with improved uptake and retention without changing programme content or CT. Self-reported HIV prevalence and SRH/HIV vulnerability were assessed via a self-administered questionnaire at baseline, after 11 sessions, and 6-30 months' post-intervention for a subset. Mixed effect logistic regression models were fitted to estimate within-subject changes in outcomes. RESULTS: Of 5116 participants, 904 (452 participants per arm) were in the pilot and 4212 (2039 "care" participants and 2173 "C+C" participants) were in the post modified phase. There were 1867 (85.9%) and 135 (6,6%) participants in the "C+C" group and the "Care," respectively, that were WoW completers (≥ 11 sessions/retention). During the pilot phase, 194 (42.9%) and 18 (4.0%) participants in "C+C" and the "care" groups were retained. Receiving a CT sustained participation nearly 60-fold (OR 60.37; 95% CI: 17.32; 210.50, p <0.001). Three-hundred and thirty women were followed for a median of 15.0 months [IQR: 13.3; 17.8] to assess the durability of impact. Self-reported new employment status increased more than three-fold (p <0.001) at WoW completion and was sustained to the longer time point. Intimate partner violence indicators were reduced immediately after WoW, but this was not durable. CONCLUSIONS: Participants receiving CT had sustained participation in an SRH/HIV prevention skills building with improvement in employment and some SRH outcomes. Layered, "young woman centred" programmes to address HIV and SRH risk in young women may be enhanced with CT.

Khuluma: Using Participatory, Peer-Led and Digital Methods to Deliver Psychosocial Support to Young People Living With HIV in South Africa.

Khuluma is a psychosocial and peer-to-peer mHealth intervention that uses text messaging to facilitate support groups for adolescents living with HIV (ALWH) with the aim of contributing toward positive health outcomes. Although use of mobile technology in the form of mHealth interventions has proliferated recently in the field of health, published literature describing methods and processes of its application are limited. We present a set of methods and processes utilised to develop and pilot the Khuluma mHealth intervention amongst young people (15-20 years) in South Africa. We recruited and enrolled 52 adolescents (15-20-year olds) from four clinics in Pretoria and Cape Town to participate in a 6-month pilot of Khuluma. Participants were ALWH, aware of their status, on antiretroviral therapy for more than 12 months, and not suffering from severe depression. We conducted four pre and post intervention focus group discussions (FGDs) with a proportion of ALWH (n = 36) enrolled in the pilot study using participatory methods. Several processes were utilised to then implement this pilot study. These included engaging ALWH for minor study implementation modifications; forming virtual groups; activating the mHealth platform; facilitating and delivering the Khuluma intervention. The acceptability of the intervention was informed by follow-up focus group discussions and text message data. The initial participatory processes helped to tailor the intervention design to participants' needs. The peer-led facilitation of the groups allowed for the provision of sensitive psychosocial support that allowed young people to express themselves freely, develop a sense of self-worth, and interact more. The nature of the mobile technology also allowed participants to build friendships beyond their geographic area and interact with their peers in real time. Within the evolving context of COVID-19, establishing evidence-based processes and methods for intervention design and curation in virtual spaces is critical.

A review of the atomoRapid HIV self-testing device: an acceptable and easy alternative to facilitate HIV testing.

Introduction:HIV testing is the gateway to both HIV prevention and treatment, and increased HIV testing and linkage to services is vital for an effective HIV response. HIV testing has progressed significantly from a lengthy laboratory process conducted by specialist medical staff to rapid point of care testing performed by trained lay staff. Despite HIV testing services being widely available, testing rates remain suboptimal among young people and men. Alternative delivery strategies that complement conventional testing services are needed to reach these priority groups. Areas covered:This article reviewed the AtomoRapid HIV self-testing (HIVST) device as an innovative alternative to conventional testing. Expert commentary:HIVST complements traditional HIV testing options and can be used to overcome major barriers to testing by catering for testing outside of conventional settings and by allowing individuals to test themselves privately, and at their own discretion and frequency. We conclude that the high sensitivity, specificity, acceptability, usability, and fidelity of this device makes it an appropriate option for the enhancement of HIV testing strategies for harder to reach populations, such as young people and men.

Adolescent lives matter: preventing HIV in adolescents.

PURPOSE OF REVIEW: Many of the almost 2 million HIV infections that occurred globally in the last year occurred among adolescents and young people, particularly those from East and Southern Africa and within key populations. Global HIV epidemic control will require that new infections among these youth populations be curtailed. This review examines the most effective prevention approaches to reach these adolescent populations in the next 5 years. RECENT FINDINGS: Adolescents are in transition and are developmentally unique. They have specific needs and challenges, which if not addressed will result in less than successful interventions. Tailored, layered, combination prevention packages that take into account specific adolescent needs and involve biomedical, behavioural and structural components are recommended. These packages should be designed for and with the meaningful input of adolescents, and involve their peers in their implementation and execution. Where possible, age-appropriate health and social interventions that go beyond HIV should be bundled and offered in a variety of community-based venues that are already acceptable to and frequented by adolescents. SUMMARY: It is urgent that we reach adolescents globally with the most effective HIV prevention approaches. HIV prevention investment in this population has immediate and longer-term benefits.