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ObjectivesBroad 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.MethodsFrom 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.ResultsAcross 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.ConclusionsThis 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.

IntroductionFacility-based HIV testing does not capture many adults and children who are at risk of HIV in South Africa. This underscores the need to provide targeted, age-appropriate HIV testing for children, adolescents, and adults who are not accessing health facilities. While home-based counseling and testing has been successfully delivered in multiple settings, it also often fails to engage adolescents. To date, the full potential for testing entire families and linking them to treatment has not been evaluated.MethodsThe steps to expand a successful home-based counseling and testing model to a family-based counseling and testing approach in a high HIV prevalence context in rural South Africa are described. The primary aim of this family-based model is to increase uptake of HIV testing and linkage to care for all family members, through promoting family cohesion and intergenerational communication, increasing HIV disclosure in the family, and improving antiretroviral treatment uptake, adherence, and retention. We discuss the three-phased research approach that led to the development of the family-based counseling and testing intervention.ResultsThe family-based intervention is designed with a maximum of five sessions, depending on the configuration of the family (young, mixed, and older families). There is an optional additional session for high-risk or vulnerable family situations. These sessions encourage HIV testing of adults, children, and adolescents and disclosure of HIV status. Families with adolescents receive an intensive training session on intergenerational communication, identified as the key causal pathway to improve testing, linkage to care, disclosure, and reduced stigma for this group. The rationale for the focus on intergenerational communication is described in relation to our formative work as well as previous literature, and potential challenges with pilot testing the intervention are explored.ConclusionThis paper maps the process for adapting a novel and largely successful home-based counseling and testing intervention for use with families. Expanding the successful home-based counseling and testing model to capture children, adolescents, and men could have significant impact, if the pilot is successful and scaled-up.

South Africa launched a mass COVID-19 vaccination campaign in May 2021, targeting 40 million adults. Understanding predictors of COVID-19 vaccine intentions was required to achieve this goal. We conducted a population-based survey in June–July 2021 using the WHO Behavioral and Social Drivers (BeSD) of COVID-19 Vaccination tool to determine predictors of vaccine hesitancy, defined as intention to refuse or uncertainty whether to accept COVID-19 vaccination. There were 1193 participants, mean age 39 (standard deviation 15) years, and 53% women, of whom 58% trusted information provided by healthcare workers and 32% were vaccine hesitant. Independent predictors of vaccine hesitancy included concerns about side effects (odds ratio (OR) 11.41; 95% confidence interval (CI) 3.5–50.80), lack of access to the online vaccine registration platform (OR 4.75; CI 2.15–10.37), distrust of government (OR 3.0; CI 1.33–6.77), belief in conspiracy theories (OR 3.01; CI 1.32–6.77), having no monthly income (OR 1.84; CI 1.12–3.07), and depending on someone else to make vaccination decision (OR 2.47; CI 1.06–5.77). We identified modifiable predictors of vaccine hesitancy at the start of South Africa’s COVID-19 vaccination rollout. These factors should be addressed by different stakeholders involved in the national immunization program through tailored communication and other effective strategies that increase vaccine literacy, reach low-income households, and engender confidence in government.

There is little published literature on the ethical concerns of stakeholders in HIV vaccine trials. This study explored the ethical challenges identified by various stakeholders, through an open-ended, in-depth approach. While the few previous studies have been largely quantitative, respondents in this study had the opportunity to spontaneously identify the issues that they perceived to be of priority concern in the South African context. Stakeholders spontaneously identified the following as ethical priorities: informed consent, social harms, collaborative relationships between research stakeholders, the participation of children and adolescents, access to treatment for participants who become infected with HIV, physical harms, fair participant and community selection, confidentiality, benefits, and payment. While there is some speculation that research in developing countries poses special ethical challenges, overall no issues were identified that have not been anticipated in international guidance, literature and popular frameworks. However, the South African context affords a distinctive gloss to these expected issues; for example, respondents were concerned that the predominant selection of black participants may perpetuate racist practices of apartheid. Stakeholders should be aware of contextual factors impacting on the implementation of ethical principles. We make a series of recommendations for South African trials, including amendments to the ethical-legal framework and research policies, and, for further research.

South Africa (SA) has progressive legislation enabling adolescents to access various sexual- and reproductive-health services (SRH) independently, without consent from parents or legal guardians. This article reviews the SA legislative framework for adolescent access to SRH interventions. It outlines the five approaches adopted in current legislation to address adolescents’ capacity to independently consent to specified health interventions, based on age, capacity and public policy requirements, or combinations thereof. Rather than subsume various health interventions under the umbrella of medical treatment, SA has separately legislated on many SRH interventions (e.g. HIV testing, contraceptives and terminations of pregnancy, among others). We identify strengths and weaknesses of the SA approach, and conclude with lessons learned from the SA experience which could inform discussion and debate on the most appropriate ways for countries to consider law reform that facilitates adolescent access to SRH services.

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Globally, individuals ages 15-24 make up one third of all new HIV infections. 1 Risk factors for HIV infection, especially drug use and unprotected sex, often first present during adolescence. 2 In South Africa (S.A.), young women in relationships with older men are at increased risk, 3 and young women and girls aged 15-24 are four times more vulnerable to HIV infection than their male peers. 4 In parts of the U.S., adolescents remain at high risk for HIV, particularly young men who have sex with men (MSM). 5 This heightened risk for HIV infection makes adolescents a critical target for HIV prevention interventions. 6 Because adolescents and adults differ in many respects, including pharmacokinetics of antiretrovirals, 7 immune responses to vaccines, 8 and sexual behaviors, 9 it is essential to enroll adolescents in HIV prevention research. It is therefore important to identify and address barriers to adolescent participation in such research.Prior assessments have identified several potential barriers, such as reporting requirements regarding abuse/neglect or under-age sex, 10 social pressure not to participate, 11 andcritically-requirements for parental consent (or, more precisely, "permission"). 12 International and national laws generally require that one or both parents give permission for their children (typically individuals younger than 18) to participate in research, though