article · PLOS Global Public Health
Clinical trials for preventive HIV vaccines rely heavily on volunteer participation, but revealing trial involvement can influence participant recruitment, engagement, and retention. This qualitative study investigated the disclosure experiences of female sex workers participating in a Phase IIb HIV vaccine trial in Dar es Salaam, Tanzania. Through focus groups and interviews, three central themes were identified: reasons for disclosure, reasons for non-disclosure, and the consequences of disclosure. Participants disclosed their involvement intentionally to find support and share information within trusted circles, or unintentionally due to trial-related events. Conversely, participants avoided disclosing due to fears of inadequate support and perceived public misunderstanding. Revealing their participation resulted in negative social consequences, such as peer disapproval of the trial, worries over vaccine side effects, and false assumptions that the volunteers were already living with HIV. The findings emphasise the necessity of stronger community education and support systems.
Conducting successful HIV vaccine trials requires high volunteer retention and trust. When participants face social disapproval, stigma, and false beliefs that the trial vaccine causes HIV, their willingness to remain involved can be compromised. Understanding disclosure experiences helps clinical researchers and public health programmes build better community education, safeguarding both participant welfare and the integrity of critical vaccine development.
This qualitative research does not describe a commercial product or technical invention. Instead, it provides actionable insights that clinical trial sponsors, contract research organisations, and biopharmaceutical developers can use to design more effective participant retention strategies and community engagement programmes for late-stage clinical trials. As this study examines social factors within an ongoing Phase IIb trial, the operational recommendations can be applied immediately to current and future clinical study designs.
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Globally, HIV vaccine clinical trials are conducted in the quest for an effective preventive vaccine. Volunteers' participation is vital to the success of these trials. However, disclosing involvement in a vaccine trial may have significant consequences, potentially affecting key aspects such as recruitment, retention, and overall engagement. This study aimed to explore the experiences of disclosure and non-disclosure of participation in a Phase IIb HIV Vaccine Trial among female sex workers in Dar es Salaam, Tanzania, and used a descriptive qualitative design. Fifteen in-depth interviews and four focus group discussions were conducted among volunteers who were participating in the HIV vaccine trial. Data analysis was done manually using the framework method. Three themes emerged: reasons for disclosure, reasons for non-disclosure, and consequences of disclosure. Reasons for disclosure were grouped into two categories: intended disclosure and unintended disclosure. Intended disclosure occurred to seek support for trial participation and to share information within trusted relationships. Unintended disclosure arose from circumstances related to trial participation. Reasons for non-disclosure had two categories: perceived lack of understanding about trial participation and concerns about inadequate support. Consequences of disclosure encompassed three categories: uncertainty about the vaccine's side effects, the perception of volunteers being infected with HIV, and disapproval of the vaccine trial. The findings reveal that volunteers experienced a complex interplay between disclosure and non-disclosure of their participation in the PrEPVacc trial. The key themes - reasons for disclosure, non-disclosure, and consequences of disclosure - underscore the importance of understanding the personal and social factors influencing these decisions. These insights highlight the need for enhanced community education and support mechanisms to address concerns, mitigate misconceptions, and improve participation in HIV vaccine trials. Trial Registration: This study was conducted as part of a multicenter phase IIb three-arm, two-stage HIV prophylactic vaccine trial with Registration Number NCT04066881, accessible at https://clinicaltrials.gov/study/NCT04066881.
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DOI: 10.1371/journal.pgph.0005511
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