I’m Positive, But I’m Negative

Abstract

HIV vaccine trials (HVTs) are ethically complex, and sound informed consent processes should facilitate optimal decision-making for participants. This study aimed to explore representations of critical HVT-related concepts to enhance the consent process. Four focus group discussions were conducted with participants from key constituencies at a South African HVT site. Thematic analysis was employed to identify representations of key HVT-related concepts. The findings suggest that (potential) participants may negotiate multiple, competing versions of HVT-related concepts in a somewhat unrecognized process, which may have significant implications for the consent process. Stakeholders involved in consent and engagement activities at sites should be assisted to elicit, engage, and resolve competing representations of HVT-related concepts. More empirical research is needed to explore how such stakeholders address competing representations in their interactions with potential participants.

Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study

“…Community stakeholders may be predisposed to suspicion about biomedical HIV prevention trials based on past negative encounters with medical research and historically-rooted mistrust in government; misunderstandings of the science underlying clinical trials (i.e., placebo, random assignment, VISP) may be superimposed on this distrust thereby engendering perceptions that trial literacy activities are not adequately or transparently implemented. This corresponds with evidence of not only misunderstanding, but of non-acceptance of some of the information offered by peer educators and trialists [ 52 ]. Thus while inculcating trial literacy is an important goal, which may in turn facilitate some equalization of power imbalances as noted in GPP, the very power imbalances to be addressed may engender doubt and disbelief in both the message and the messenger.…”

“. . . I’ve Gone Through This My Own Self, So I Practice What I Preach . . . ”

“…Many of the practices reported here from both educational and consent encounters to build trust in the information being communicated (e.g., making use of trustworthy sources) show that site staff face considerable suspicion about medical research in general, about the site itself and even about themselves ( Rautenbach et al, 2015 ). This underscores the importance of the dual goals of building “research competency” (“literacy”) and of building trusting relationships (cf.…”

“…The overall study was approved by all Research Ethics Committees affiliated to the research team, the site, and the funders [University of KwaZulu-Natal Humanities and Social Sciences Research Ethics Committee (HSS 0554/012)]. Results related to “competing” versions of key concepts were presented in an earlier article ( Rautenbach et al, 2015 ). The present article describes results regarding the strategies reportedly being used to communicate complex research concepts to prospective participants in consent and engagement encounters in HIV vaccine trials and complexities.…”

“…Also, facilitators and FGD-participants role-played the explanation of concepts to “mock” participating commu-nity members or “mock” potential participants and, subsequently, FGD-participants were invited to reflect on these role-plays to stimulate discussion about the concepts, how they are communicated, and challenges (cf. Rautenbach et al, 2015 ). All FGDs explored similar domains, but questions and prompts were tailored to the activities and roles of different trial constituencies.…”

“…There have been many efforts to enhance understanding in such trials by developing sound written consent materials ( Koblin et al, 2010 ; Lally, Goldsworthy, Sarr, Kahn, Brown, Peralta, & Zimet, 2014 ). However, commentators in this field also increasingly argue for attention to the processes by which these complex concepts are communicated ( Koblin et al, 2010 ; Ndebele, Wassenaar, Masiye, & Munula-Nkandu, 2014 ; Rautenbach, Lindegger, Slack, Wallace, & Newman, 2015 ; Watermeyer & Penn, 2008 ). Yet, there is very little published work evaluating communication during consent interactions in HIV vaccine trials ( Watermeyer & Penn, 2008 ).…”