Motivations and concerns about adolescent tuberculosis vaccine trial participation in rural Uganda: a qualitative study.

Esther Buregyeya,Asli Kulane,Harriet Mayanja,Juliet Kiguli,Phillipa Musoke,Ellen Maeve Hanlon

doi:10.11604/pamj.2015.22.76.7097

Esther Buregyeya, Asli Kulane + Show 4 more

Open Access

https://doi.org/10.11604/pamj.2015.22.76.7097

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Abstract

IntroductionResearch is being carried out to develop and test new potentially more effective tuberculosis vaccines. Among the vaccines being developed are those that target adolescents. This study explored the stakeholders’ perceptions about adolescent participation in a hypothetical tuberculosis vaccine trial in Ugandan adolescents.MethodsFocus group discussions with adolescents, parents of infants and adolescents, and key informant interviews with community leaders and traditional healers were conducted.ResultsThe majority of the respondents expressed potential willingness to allow their children participate in a tuberculosis vaccine trial. Main motivations for potential participation would be being able to learn about health-related issues. Hesitations included the notion that trial participation would distract the youths from their studies, fear of possible side effects of an investigational product, and potential for being sexually exploited by researchers. In addition, bad experiences from participation in previous research and doubts about the importance of research were mentioned. Suggested ways to motivate participation included: improved clarity on study purpose, risks, benefits and better scheduling of study procedures to minimize disruption to participants’ academic schedules.ConclusionFindings from this study suggest that the community is open to potential participation of adolescents in a tuberculosis vaccine trial. However, there is a need to communicate more effectively with the community about the purpose of the trial and its effects, including safety data, in a low-literacy, readily understood format. This raises a challenge to researchers, who cannot know all the potential effects of a trial product before it is tested.

Highlights

IntroductionOne out of every three people is estimated to be infected with the causative agent Mycobacterium tuberculosis[1]
Research is being carried out to develop and test new potentially more effective tuberculosis vaccines
Our study explored willingness of adolescents, parents and care takers in allowing their adolescents participate in future TB vaccine trials

Summary

Introduction

One out of every three people is estimated to be infected with the causative agent Mycobacterium tuberculosis[1]. Many volunteers living in high-burden areas are needed for phase II and III efficacy TB vaccine trials This raises one important principle of research ethics, i.e. informed consent. While the above views are clear, the question is how eager are communities in high burden settings to allow their youth to participate in TB vaccine trials. In a study in Kenya on willingness of parents to have their children receive an infant HIV-1 vaccine, the majority (97%) were willing [17] For those who were not willing, reasons for not wanting to enroll included concerns about side effects, partner objection, fear of discrimination, and HIV-1 acquisition [17]. No studies have examined parents/caretakers willingness to allow their adolescents participate in a TB vaccine trial in Uganda. Our study explored willingness of adolescents, parents and care takers in allowing their adolescents participate in future TB vaccine trials

Methods

Study design

Ethical considerations

Results

Discussion

Conclusion