A qualitative evaluation of volunteers' experiences in a phase I/II HIV vaccine trial in Tanzania

BACKGROUND: Evaluating experiences of volunteers in an HIV vaccine trial will be useful for the conduct of future trials. The purpose of this study among volunteers who participated in a phase I/II HIV vaccine trial in Dar es Salaam, Tanzania was to assess what characterized their experiences during the trial. METHODS: We conducted four focus group discussions with 35 out of the 60 individuals (women and men) after the five scheduled vaccinations. An interpretive description approach was applied to data analysis. RESULTS: As a result of the trial interventions, both men and women gained confidence in their own abilities to have safer, less risky sexual behaviour. The participants experienced the trial as a way of accessing free [insured] medical services. Most of the men said they had gone from self-medication to professional medical consultation. Despite these benefits, the participants faced various challenges during the trial. Such challenges included mistrust of the trial shown by health care providers who were not connected to the trial and discouragement from friends, colleagues and family members who questioned the safety of the trial. However, they managed to cope with these doubts by using both personal and trial related interventions. CONCLUSION: We found that during the phase I/II HIV vaccine trial, participants had both the opportunities and the ability to cope with the doubts from the surrounding community. Follow up visits enhanced the opportunities and individuals' abilities to cope with the doubts during the trial. Understanding this discourse may be useful for the trial implementers when designing future trials. TRIALS REGISTRATION: ISRCTN: ISRCTN90053831 Pan African Clinical Trials Registry (PACTR): ATMR2009040001075080