Reasons for Declining to Enroll in a Phase I and II HIV Vaccine Trial after Randomization among Eligible Volunteers in Dar es Salaam, Tanzania

Abstract

BackgroundRecruitment, enrollment and retention of volunteers in an HIV vaccine trial is important in the efforts to ultimately develop a vaccine that can prevent new HIV infections. Following recruitment, some randomized individuals decline to be enrolled in an HIV vaccine trial. The reasons for such a decision are not well known. This article describes why individuals who were randomized in a phase I and II HIV vaccine trial in Dar es Salaam, Tanzania declined to be enrolled.MethodsFace-to-face interviews were conducted with 14 individuals (7 men and 7 women). Repeated readings of the 14 interview transcripts to look for reasons for declining to enroll in the trial were performed. Data was analyzed using the content analysis approach.ResultsInformants expressed fear of the outcome of an experimental HIV vaccine in their lives. Unlike women, some men were concerned over the effect of the vaccine on their reproduction intentions. Women were concerned about the unknown effects of the vaccine in their bodies. Also, to a large extent, informants faced resistance from significant others such as fiancées, parents, relatives, and friends. Women were influenced by their potential intimate sexual partners; men were forbidden by their parents, and mothers had the most influential opinion.ConclusionsFear of the negative outcome of an experimental vaccine and resistance from significant others are the main reasons for declining to enroll in the HIV vaccine trial among eligible volunteers after randomization. The resistance from the significant others provides valuable guidance for designing future trials in Tanzania; for example, expanding the HIV vaccine trial education to the general population from the onset of the trial design.

Reasons behind the participation in biomedical research: a brief review

“…Fear of possible (negative) outcome and resistance from "significant others" (usually parents and close friends) were the main obstacles. These findings call attention to the importance of expanding clinical trial education and its benefit to general population 19 .…”

Complete blood count reference intervals from a healthy adult urban population in Kenya

“…A criticism of RI studies especially those done in economically disadvantaged areas is that the recruited population may not necessarily be representative of an ideal reference population. There are different motivators to volunteer in a study and these can result in a selection bias hence compromising the external validity of the study results [ 12 , 13 ]. We set out to determine RIs for complete blood counts (CBCs) in Kenya using data from carefully selected healthy individuals recruited as part of a multicenter, multi-country, global RI study conducted by the Committee of Reference Intervals and Decision Limits (C-RIDL) under the auspices of the International Federation of Clinical Chemistry (IFCC).…”

Gender aspects on HIV prevention efforts and participation in HIV vaccine trials among Police officers in Dar es Salaam, Tanzania

“…The fact that men demonstrate readiness to motivate their spouses to take part in HIV vaccine trials is worth noting. On the contrary, a previous study within the same Police cohort showed that spouses were against partner participation in HIV vaccine trials in the sense that the experimental vaccine could affect them in diverse ways [ 8 ]. Mistrust of HIV vaccine trials is not unique in this study, implying that more education on the concepts and conduct of HIV vaccine trials is needed [ 24 – 26 ].…”

“…This was a descriptive qualitative study design which builds on a series of socio-behavioral studies, which were conducted in an open cohort of POs between 2007 and 2012 [ 4 – 8 ]. In brief, this was a part of HIV vaccine trial studies where rapport was already created in initial studies.…”