¹University of Toronto, Toronto, ON, Canada, ²University of Kwa-Zulu Natal, Scottsville, South Africa, ³Indian Network for People Living with HIV/AIDS, Chennai, India, ⁴King Mongkut University of Technology, Bangkok, Thailand

Background: HIV/AIDS disproportionately impacts low-and-middle-income-countries (LMIC), which account for 95% of persons living with HIV/AIDS (PLHA) globally. Despite advances in controlling HIV/AIDS, new prevention and treatment technologies are largely unavailable to persons at highest risk of HIV exposure in LMIC settings; globally, 12,000 people are newly infected every day. Ultimately, an HIV vaccine is our greatest hope for reversing the epidemic. Yet vaccine development requires clinical trials involving thousands of persons at high-risk of HIV exposure; launching clinical trials in LMIC settings entails social and ethical challenges exacerbated by differences in wealth, power, scientific expertise and infrastructure between high-income and LMIC settings. Meaningful community engagement is increasingly important to implementing safe and ethical trials in LMIC settings. In order to identify key challenges and constructive strategies for community engagement in international HIV vaccine trials, we explored the perspectives of local communities and civil society organization (CSO) representatives in four countries.

Methods: From 2007-2009, we conducted an embedded, exploratory multiple case study in South Africa, India, Thailand and Canada. In collaboration with University researchers and CSOs, we developed a semi-structured interview guide adapted to reflect local priorities and contexts (e.g., focal populations at risk; history of involvement with HIV prevention trials). We used purposive sampling to recruit CSO representatives, community advocates, and HIV service providers for in-depth interviews, and individuals from "high-risk" populations for focus groups. Interviews and focus groups were digitally recorded, transcribed verbatim and translated into English. We used narrative thematic techniques from grounded theory--line-by-line and focused coding, and a constant comparative method--to analyze data within each country. We then synthesized and contrasted themes across cases.

Results: Across participants (n=182; 61% men, 37% women, 2% transwomen) in 11 focus groups (n=90) and 92 in-depth interviews, cross-cutting themes emerged at individual, social and structural levels. Individual-level themes included comprehension of trial risks, consent, and “preventive misconception” (believing oneself protected due to trial participation), which converged in challenges to ensuring truly informed consent and avoiding increased harm. Social-level themes included altruism, community participation, stigma, and mistrust; challenges converged in competing representations of trial participants as altruistic global citizens versus “promiscuous” risk groups. Structural-level themes included HIV education, access to healthcare, discrimination, and media. LMIC-specific concerns included capacity-building, siloization of CSO knowledge, and economic disparities between trial sponsor and LMIC settings (India, Thailand, South Africa); and cultural norms that prioritize family over individual interests (India, Thailand).

Conclusions: This international collaboration suggests opportunities, particularly through South-South knowledge mobilization, for addressing multi-level challenges to launching safe and ethical clinical trials in LMIC settings, and achieving meaningful community engagement. International community engagement may mobilize baseline ethical criteria to ensure trial participants access to healthcare and to investigational vaccines found to be efficacious. Nevertheless, differences in local cultures, laws, discrimination, and healthcare access also must be addressed at the country-level. Empirically-based identification of challenges to meaningful community engagement suggests pathways to advance safe and ethical HIV prevention trials in LMIC settings with the most urgent need for new HIV prevention technologies.