A Qualitative Study on Experiences of HIV Vaccine Trial Participants in a Phase I/II Double Blinded, Randomized Placebo Controlled Clinical Trial in Tanzania: Lessons for COVID-19 Vaccine Testing

Abstract

Background: HIV remains a major public health problem in Sub-Saharan Africa. More than half (54.5%) of all people living with HIV live in Eastern and Southern Africa where 700,000 new infections were reported in 2019. There is no HIV vaccine or cure available yet despite ongoing research to develop one. Uptake of vaccines, when these become available, is critical for its successful introduction in the global society. It is imperative to describe the knowledge, expectations, perceptions and experiences of the vaccines trial participants, as these may be indicative of future vaccine uptake, and may give lessons for COVID-19 vaccine development. Methods: A phenomenological qualitative study was conducted to describe the experiences of volunteers who participated in the first HIV vaccine trial in Mbeya, Tanzania. A purposive sample of 20 of the 60 trial participants was interviewed. Interviews were audio-recorded, transcribed, translated, and subjected to thematic-content analysis.Results: The study showed that trial participation was driven by positive expectations related to health and the realization of the need for an effective vaccine to combat HIV. However fear, concerns and worries about the safety of the trial vaccine were the frequently reported challenges to participation. Not only participants but also the significant others and community play an important role in the trial participation.Conclusions: The success of a trial depends on direct and indirect participation in trials. Future trials, COVID-19 vaccine trials included, must promote positive expectations for trial participation and address fears and concerns related to vaccine safety.