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Background The South African legal framework requires mandatory parental/legal guardian consent for all research with children. Ethics guidelines provide some reprieve by allowing RECs to grant waivers of parental or guardianship consent in certain defined circumstances. In the first instance, consent may be provided by a proxy when parents or guardians are unavailable, for example with orphaned children. In the second instance, guidelines permit adolescent self-consent when the nature of the study justifies this approach, for example, research on sensitive issues like sexual behaviour or substance use. Discussion South African guidelines set several conditions that must be met for waivers to be granted. These norms overlap with those in international guidelines. However, the ethical norms, especially related to self-consent are sometimes vague. This article critically evaluates the consent norms in the national ethics guidelines and makes recommendations for reform to ethics guidelines in a way that recognises the value of child participation in research, their evolving decision-making capacity and their best interests. Conclusion Recommendations are made to harmonise ethics guidelines and law in a way that promotes child participation in research, to ensure additional protections for adolescents when self-consent is allowed, and to withdraw procedural requirements for the community endorsement of self-consent strategies.

Background . Independent ethics review of research is required prior to the implementation of all health research involving human participants. However, ethics review processes are challenged by protracted turnaround times, which may negatively impact the implementation of socially valuable research. Previous research has documented delays in ethics review in developed and developing countries. This study aimed to determine the extent of variability in turnaround times for protocol review among different institutional review boards (IRBs) within Tanzania. Methods . This descriptive cross-sectional study employed a mixed-method approach, with qualitative and quantitative components. Seven IRBs were purposively sampled from the 15 accredited IRBs operational in Tanzania during the study period, April 2017–April 2018. Quantitative data were analysed using STATA software and qualitative data were analysed thematically. Results . The median time for review across all IRBs was 32 days, with a range of 1–396 days. Qualitative results identified five key themes related to turnaround time from interviews with participants. These included: (1) procedures for receiving and distribution of protocols, (2) number of reviewers assigned to protocols, (3) duration of reviewing protocols, (4) reasons for delayed feedback, and (5) training of research ethics committee members. Conclusion. The study showed that the median days for ethical approval in Tanzania was 32 days. We observed from this study that electronic submission systems facilitated faster turnaround times. Failure to adhere to the submission checklists and guidelines was a major obstacle to the turnaround time.

Partizipative Forschungsansätze, bei denen die Teilnehmer*innen im Mittelpunkt der Forschung stehen, haben sich als erfolgreich erwiesen, um deren Engagement und Äußerungsbereitschaft zu unterstützen. In diesem Artikel beschreiben wir unsere Erfahrungen mit einer neuartigen, hybriden partizipatorischen Methodik, den Expression Sessions (ES), mit Heranwachsenden. Wir erläutern insbesondere, wie wir ES konzeptualisiert und operationalisiert haben und diskutieren die Nützlichkeit dieses Ansatzes. Im Verlauf unserer Studie wurden 24 Fokusgruppendiskussionen mit 144 Jugendlichen zwischen 12 bis 17 Jahren durchgeführt. Wir haben festgestellt, dass durch die ES die aktive Teilnahme gefördert, offene und aussagekräftige Äußerungen erleichtert und die gemeinsame Reflexion verbessert wurden. Durch den ES-Ansatz hatten die Teilnehmer*innen die Freiheit, die ihnen am sinnvollsten erscheinenden Ausdrucksweisen zu wählen, was die Reflexion und Diskussion von Themen auf neue, sinnvolle Weise erleichterte. In diesem Artikel stellen wir daher eine alternative, partizipative Methodik vor, die von qualitativen Forscher*innen und bei unterschiedlichen Untersuchungsgruppen leicht angewendet werden kann.

There is strong evidence that gay, bisexual and other men who have sex with men (GBMSM) in African countries experience high prevalence of HIV. However, missing from the literature is an understanding of the HIV risk behaviors and prevention needs of partnered GBMSM in African countries. The Together Tomorrow project sampled 440 partnered GBMSM (220 couples) in South Africa and Namibia. Prevalence of HIV was high at 42%, with 33% of men in sero-discordant relationships. Despite high levels of HIV testing in the past 6 months (65%), condom use with main and outside sex partners was low. Men reported low levels of willingness to use pre-exposure prophylaxis (PrEP) (16%). HIV testing in the past 12 months and willingness to use PrEP were significantly associated with recent binge drinking and substance use. Men in sero-discordant relationships, those with sexual agreements and those who had experienced any form of IPV were all less likely to report that they had recently tested for HIV. There is a need to develop interventions that meet the unique needs of African partnered GBMSM and tackle stigma and discrimination as drivers of HIV risk in these settings.

Despite the growing body of evidence demonstrating the high prevalence of intimate partner violence (IPV) among male couples and the unique antecedents to IPV that male couples may experience, research efforts have focused almost exclusively on North American populations. Missing from the literature is an understanding of the experience of IPV among male couples in African nations where social norms and legal restrictions around same-sex behavior may be more conservative. This paper presents data from an innovative study of male couples (Together Tomorrow) from two Southern African countries characterized by high prevalence of HIV: Namibia and South Africa. A one-time cross-sectional survey was conducted with 140 partnered MSM (70 couples) in Namibia and 300 partnered MSM (150 couples) in KZN, South Africa, for a total sample size of 440 partnered MSM (220 couples). Surveys measured the recent (12 month) experience of physical, sexual and emotional IPV and the experience of sexuality-related stressors. Reporting of IPV was relatively low: 7.3% reported being the victim of IPV from their male partner in the 12 months prior to the survey, and 10.2% reported participating in bi-directional IPV in their relationship in the previous 12 months. Men who reported different experiences of internalized homophobia and external acts of discrimination were more likely to report IPV and bi-directional IPV. The results offer several potential intervention points to disrupt pathways between stigma and IPV for partnered MSM in South Africa and Namibia, and point to the need for services for this critically overlooked population.

Introduction In 2023, one‐fourth of new HIV acquisitions in children globally resulted from vertical transmission following incident HIV during pregnancy or breastfeeding. Oral pre‐exposure prophylaxis (PrEP) with tenofovir disoproxil and emtricitabine is safe and effective in pregnancy and postpartum, with long‐acting options emerging. Integrating PrEP into antenatal and postnatal care (ANC/PNC) is a crucial person‐centred approach to prevent maternal HIV acquisition and vertical transmission. This review summarizes oral PrEP initiation, continuation and adherence among pregnant and postpartum women receiving ANC/PNC. Methods We systematically searched three databases for English‐language quantitative studies published between 1 January 2015 and 28 March 2024. Eligible studies focused on pregnant and/or postpartum women accessing PrEP through ANC/PNC, and reported on initiation (receipt of prescription or self‐reported use), continuation (persistent use over time) and/or adherence (self‐reported and/or objective). Results We identified 481 articles; 12 studies from Kenya, Lesotho, Malawi and South Africa met our inclusion criteria. Study heterogeneity (e.g. definitions used, population included, follow‐up time) precluded meta‐analysis. All studies enrolled pregnant women; three also enrolled postpartum women. Median gestational age at enrolment ranged from 20 to 26 weeks, and follow‐up periods from 1 month post‐enrolment to 12 months postpartum. Oral PrEP initiation ranged from 14% to 84%. Continuation at 3 months ranged from 22% to 90% and declined postpartum in all studies. Self‐reported adherence (daily use) ranged from 11% to 81% in the past 7 or 30 days at 1 month (four studies) and from 54% to 81% at 3 months (two studies). Objectively measured adherence ranged from 34% to 62% for detectable tenofovir or tenofovir diphosphate levels at 1 month (three studies). One Kenyan trial demonstrated that universal versus risk‐based offers of oral PrEP resulted in similar PrEP use and HIV incidence. Two‐way SMS communication (Kenya) and real‐time adherence biofeedback counselling using urine tenofovir testing (South Africa) enhanced PrEP continuation/adherence compared to standard‐of‐care. Discussion Integrating oral PrEP into ANC/PNC showed high initiation among pregnant/postpartum women; however, continuation and adherence were suboptimal. Conclusions Oral PrEP integration into ANC/PNC can reach pregnant/postpartum women. Maximizing its impact will require offering long‐acting PrEP, person‐centred interventions to support adherence/continued use and differentiated delivery responsive to women's needs. PROSPERO Number CRD42024513442

Despite having some of the world’s highest rates of HIV, there is a lack of knowledge on correlates of transmission risk among gay, bisexual and other men who have sex with men in Southern Africa. There is even less known about the factors that shape HIV risk in male-male couples. Using data from Together Tomorrow, a study of partnered GBMSM in South Africa and Namibia, this study assessed the individual and dyadic correlates of three major HIV risk factors in this population: substance misuse, transactional sex, and depressive symptomatology. Data were collected during November 2016–March 2017 via a quantitative survey conducted with 140 partnered MSM (70 couples) in Windohoek, Keetmanshoop, Walvis Bay, and Swakopmund, Namibia and 300 partnered MSM (150 couples) in Pietermaritzburg and Durban, KwaZulu-Natal, South Africa for a total sample size of 440 partnered MSM (220 couples). Results of multilevel modeling analyses show several significant factors present in partnered GBMSM that differ from studies of single GBMSM, with intimate partner violence being a significant correlate across all three risk factors. Future interventions should consider dyadic approaches and integrate IPV prevention and mitigation efforts to reduce HIV in this population as part of a multisectoral approach. To reduce rates of HIV in partnered GBMSM in Namibia and South Africa multilevel, multisectoral work is needed in policy, social norms change, and relationship-focused dyadic interventions to reduce the social and structural stigma facing male couples.

Broad international guidelines and studies in the context of individual clinical trials highlight the centrality of community stakeholder engagement in conducting ethically rigorous HIV prevention trials. We explored and identified challenges and facilitators for community stakeholder engagement in biomedical HIV prevention trials in diverse global settings. Our aim was to assess and deepen the empirical foundation for priorities included in the GPP guidelines and to highlight challenges in implementation that may merit further attention in subsequent GPP iterations. From 2008-2012 we conducted an embedded, multiple case study centered in Thailand, India, South Africa and Canada. We conducted in-depth interviews and focus groups with respondents from different trial-related subsystems: civil society organization representatives, community advocates, service providers, clinical trialists/researchers, former trial participants, and key HIV risk populations. Interviews/focus groups were recorded, and coded using thematic content analysis. After intra-case analyses, we conducted cross-case analysis to contrast and synthesize themes and sub-themes across cases. Lastly, we applied the case study findings to explore and assess UNAIDS/AVAC GPP guidelines and the GPP Blueprint for Stakeholder Engagement. Across settings, we identified three cross-cutting themes as essential to community stakeholder engagement: trial literacy, including lexicon challenges and misconceptions that imperil sound communication; mistrust due to historical exploitation; and participatory processes: engaging early; considering the breadth of \"community\"; and, developing appropriate stakeholder roles. Site-specific challenges arose in resource-limited settings and settings where trials were halted. This multiple case study revealed common themes underlying community stakeholder engagement across four country settings that largely mirror GPP goals and the GPP Blueprint, as well as highlighting challenges in the implementation of important guidelines. GPP guidance documents could be strengthened through greater focus on: identifying and addressing the community-specific roots of mistrust and its impact on trial literacy activities; achieving and evaluating representativeness in community stakeholder groups; and addressing the impact of power and funding streams on meaningful engagement and independent decision-making.

Background Of the 8 million people in South Africa living with HIV, 74% of persons living with HIV are on antiretroviral therapy (ART) and 65% are virally suppressed. Detectable viral load results in HIV-associated morbidity and mortality and HIV transmission. Patient barriers to care, such as missed wages, transport costs, and long wait times for clinic visits and ART refills, are associated with detectable viral load. HIV differentiated service delivery (DSD) has simplified ART delivery for clients who achieve viral suppression and engage in care. However, DSD needs adaptation to serve clients who are not engaged in care. Methods A Sequential Multiple Assignment Randomized Trial will be undertaken in KwaZulu-Natal, South Africa, to test adaptive ART delivery for persons with detectable viral load and/or who are not engaged in care. The types of differentiated service delivery (DSD) which will be examined in this study are clinic-based incentives, community-based smart lockers, and home delivery. The study plans to enroll up to 900 participants-people living with HIV, eligible for ART, and who are not engaged in care. The study aims to assess the proportion of ART-eligible persons living with HIV who achieve viral suppression at 18 months. The study will also evaluate the preferences of clients and providers for differentiated service delivery and evaluate the cost-effectiveness of adaptive HIV treatment for those who are not engaged in care. Discussion To increase population-level viral suppression, persons with detectable viral load need responsive DSD interventions. A Sequential Multiple Assignment Randomized Trial (SMART) design facilitates the evaluation of a stepped, adaptive approach to achieving viral suppression with “right-sized” interventions for patients most in need of effective and efficient HIV care delivery strategies. Trial registration ClinicalTrials.gov NCT05090150. Registered on October 22, 2021

IntroductionTuberculosis (TB) remains the leading cause of infectious disease deaths, particularly among people living with HIV (PWH). Despite being preventable, TB preventive therapy (TPT) uptake is low in high-burden regions like South Africa, where new guidelines have expanded TPT eligibility and introduced shorter, more effective regimens like 3 months of weekly rifapentine and isoniazid (3HP). As differentiated service delivery models for HIV care have proven effective, there is increasing recognition that decentralising TPT delivery may improve coverage and completion. This study explores whether a community-based TPT delivery strategy can enhance uptake and completion of TPT compared with traditional clinic-based services.Method and analysisWe will conduct a household-randomised, non-blinded, controlled trial. Persons eligible for TPT will be recruited from the TB TRIAGE+Trial study, a community-based household TB screening study. Households containing at least one person eligible for TPT will be randomised 1:1 to either community-based TPT or standard-of-care clinic referral for TPT. At enrolment, all participants will be provided with a 2-week supply of TPT in the community. Participants randomised to the community arm will receive the entire course of TPT in a single dispense (12 weeks of 3HP or 6 months of isoniazid, if 3HP is contraindicated). Clinic-arm participants will be referred to their local clinic for the remainder of their course of TPT and will collect TPT refills on the clinic-determined schedule. Our primary outcome is the proportion of participants who complete a course of TPT. Secondary outcomes include overall adherence to TPT, predictors of adherence with TPT, participant satisfaction with the assigned TPT delivery method and adverse events.Ethics and disseminationThe study and its tools were approved by the Human Sciences Research Councils Research Ethics Committee (approval number: 2/25/10/23), based in Pretoria, Gauteng, South Africa, as well as the University of Washington Institutional Review Board (Study 00018448). Study findings will be shared through the community advisory group and local stakeholder meetings, relevant international and local meetings/conferences and peer-reviewed publications.Trial registration numberNCT06214910. Date and version: 3.0, 30 July 2024.