title: Advancing community stakeholder engagement in biomedical HIV prevention trials: principles, practices and evidence.
abstract: Community stakeholder engagement is foundational to fair and ethically conducted biomedical HIV prevention trials. Concerns regarding the ethical engagement of community stakeholders in HIV vaccine trials and early terminations of several international pre-exposure prophylaxis trials have fueled the development of international guidelines, such as UNAIDS' good participatory practice (GPP). GPP aims to ensure that stakeholders are effectively involved in all phases of biomedical HIV prevention trials. We provide an overview of the six guiding principles in the GPP and critically examine them in relation to existing social and behavioral science research. In particular, we highlight the challenges involved in operationalizing these principles on the ground in various global contexts, with a focus on low-income country settings. Increasing integration of social science in biomedical HIV prevention trials will provide evidence to advance a science of community stakeholder engagement to support ethical and effective practices informed by local realities and sociocultural differences.
authors.affiliation: Factor-Inwentash Faculty of Social Work, University of Toronto, 246 Bloor Street West, Toronto, Ontario, M5S 1V4, Canada.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Newman
authors.forename: Clara
authors.initials: C
authors.lastname: Rubincam
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D002986:Clinical Trials as Topic; D003256:Community Participation; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans
chemical_list: D016915:AIDS Vaccines
keywords: HIV prevention; HIV vaccines; clinical trials; community engagement; community participation; ethics; low-income countries; mistrust; social sciences; stakeholder engagement