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Exploring communication strategies that promote sound informed consent for HIV vaccine trials.

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The development of an HIV vaccine is a foremost universal health priority, necessitating research with human volunteers. It has been internationally accepted that informed consent is a fundamental ethical requirement for all clinical trials, including HIV vaccine trials (HVTs). However prospective trial participants often demonstrate a lack of understanding of information conveyed to them during the informed consent process. Ways of communicating complex concepts may need to be identified and developed to promote understanding. This study had the following aims: (a) To explore communication strategies reportedly implemented by key HIV vaccine trial stakeholders to communicate key concepts (Community Advisory Board or CAB members, Educators, Consent Counsellors) b) To explore correspondence between reported strategies and recommendations from the conceptual and empirical literature, and c) To explore the implications for strengthening informed consent for research in resource- constrained settings. The study comprised an analysis of four Focus Group Discussions with key stakeholders at an HIV vaccine trial site in South Africa, that had been previously conducted by members of the HIV AIDS Vaccines Ethics Group from the University of KwaZulu-Natal (UKZN). These stakeholders included CAB members who interacted with participating-community members; Educators who interacted with interested community members at the site, and Consent Counsellors who interacted with persons interested in enrolment in actual HIV vaccine trials. These transcripts were analysed using Thematic Analysis, informed by aspects of a popular framework for the informing process (the Meerwein model). This study adopted a qualitative approach which was broadly set in an interpretive perspective – focusing on practices, subjective meanings that stakeholders attached to their practices, and the context. Study findings are presented under three main themes. The informational theme describes how site staff reportedly employed numerous strategies to ensure that information presented to potential participants was understandable, such as simplifying, using preferred language, using analogies, using culturally appropriate terms and promoting discussion. The emotional theme describes how site staff implemented several strategies to try respond to emotions of anxiety and to try address feelings of suspicion, such inquiring about and collating suspicions, using trustworthy sources (ex-participants or influential community members) and referring to safe, licensed vaccines. The relational theme describes how site-staff reportedly employed various practices to develop respectful relationships (by creating a friendly environment) that are responsive to cultural norms, such as requesting permission to break cultural norms, and using culturally acceptable terms. The study concludes that strategies employed appear consistent with several key principles of adult learning, and communication, as well as with ethical guideline recommendations for HIV vaccine trials. These findings imply that the individual consent process is best understood as embedded in a larger process of engagement and that consent staff at sites need to have core communicative competencies, need to be sensitive to the emotional aspects of their engagements, and need to be culturally competent. Recommendations are made for key stakeholders such as Research Ethics Committees, CAB members, and ethical guideline developers. Recommendations are made to strengthen the informed consent process for research in resource-limited settings.


Master of Social Science in Health Research Ethics. University of KwaZulu-Natal, Pietermaritzburg 2017.