HIV Vaccine Trial Participation Among Ethnic Minority Communities

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.

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Young at risk-people in Maputo City, Mozambique, present a high willingness to participate in HIV trials: Results from an HIV vaccine preparedness cohort study

PLoS ONE ◽

10.1371/journal.pone.0260126 ◽

2021 ◽

Vol 16 (12) ◽

pp. e0260126

Author(s):

Igor P. U. Capitine ◽

Ivalda B. Macicame ◽

Artur M. Uanela ◽

Nilesh B. Bhatt ◽

Adam Yates ◽

...

Keyword(s):

Logistic Regression ◽

Disease Incidence ◽

Vaccine Trial ◽

Binary Logistic Regression ◽

Hiv Vaccine ◽

Trial Participation ◽

Willingness To Participate ◽

Hiv Vaccine Trials ◽

Maputo City ◽

Study Population

Introduction Vaccine efficacy testing requires engagement of willing volunteers with high disease incidence. We evaluated factors associated with willingness to participate in potential future HIV vaccine trials in Maputo, Mozambique. Methods Adults aged 18–35 years without HIV and who reported at least two sexual partners in the 3 months prior to screening were enrolled into a 24-month observational study. They were asked at screening and exit if they would be willing to participate in a theoretical HIV vaccine study. Bivariate and multivariate logistic regression analyses were done between willingness to participate, demographic, sexual behavior, and motivational factors for screening visit data. Logistic regression with generalized estimating equations (GEE) was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for factors potentially associated with willingness to participate for data from both visits. Results A total of 577 participants without HIV were eligible, including 275 (48%) women. The mean age was 22.2 (SD ± 3.9) years. At screening 529 (92%) expressed willingness to participate and the proportion remained stable at 378 (88%) of the 430 participants retained through the exit visit (p = 0.209). Helping the country (n = 556) and fear of needles (n = 26) were the top motive and barrier for willingness to participate, respectively. Results from the GEE binary logistic regression (screening visit and exit visit) showed that wanting to learn how to avoid risk behaviors (aOR 3.33, 95% CI: 1.61–6.86) and feeling protected against HIV infection (aOR 2.24, 95% CI: 1.07–4.7) were associated with willingness to participate in HIV vaccine studies. Conclusion The majority of our study population in Mozambique expressed willingness to participate in a theoretical HIV vaccine trial. Participation in a HIV vaccine trial was seen as a way to contribute to the fight against HIV but was associated with some unrealistic expectations such as protection against HIV. This reinforces the need for continuous mobilization and awareness of potential participants to HIV vaccine trial.

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