title: Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada.
authors: Peter A
authors: PA
authors: Newman
authors: Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada.
authors: Clara
authors: C
authors: Rubincam
authors: HIV/AIDS Vaccines Ethics Group, School of Applied Human Sciences, University of KwaZulu-Natal, Pietermaritzburg, South Africa.
authors: Catherine
authors: C
authors: Slack
authors: HIV/AIDS Vaccines Ethics Group, School of Applied Human Sciences, University of KwaZulu-Natal, Pietermaritzburg, South Africa.
authors: Zaynab
authors: Z
authors: Essack
authors: Centre for Sexuality and Health Research and Policy (C-SHaRP), Chennai, India.
authors: Venkatesan
authors: V
authors: Chakrapani
authors: Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada.
authors: Deng-Min
authors: DM
authors: Chuang
authors: Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada.
authors: Suchon
authors: S
authors: Tepjan
authors: Centre for Sexuality and Health Research and Policy (C-SHaRP), Chennai, India.
authors: Murali
authors: M
authors: Shunmugam
authors: Faculty of Science and Technology, Rajamangala University of Technology Phra Nakhon, Bangkok, Thailand.
authors: Surachet
authors: S
authors: Roungprakhon
authors: Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada.
authors: Carmen
authors: C
authors: Logie
authors: HIV/AIDS Vaccines Ethics Group, School of Applied Human Sciences, University of KwaZulu-Natal, Pietermaritzburg, South Africa.
authors: Jennifer
authors: J
authors: Koen
authors: HIV/AIDS Vaccines Ethics Group, School of Applied Human Sciences, University of KwaZulu-Natal, Pietermaritzburg, South Africa.
authors: Graham
authors: G
authors: Lindegger
mesh_terms: D000328:Adult; D035843:Biomedical Research / Q000458:organization & administration*; D002170:Canada; D002986:Clinical Trials as Topic; D003256:Community Participation; D005260:Female; D017144:Focus Groups; D017408:Guidelines as Topic; D015658:HIV Infections / Q000517:prevention & control*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007194:India; D007391:International Cooperation; D008297:Male; D013019:South Africa; D009626:Terminology as Topic; D013785:Thailand