Adolescents’ and young women’s perspectives on participation in biomedical clinical trials for HIV prevention products in Tanzania

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2021

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Abstract

Adolescent girls are a vulnerable population disproportionately affected by HIV in high-prevalence settings such as sub-Saharan Africa. Despite the development of HIV prevention products and subsequent biomedical clinical trials to examine the efficacy and safety of the products, adolescent girls largely have been excluded from the clinical trials, thus delaying their potential access to these products. To further examine the challenges and opportunities for adolescent trial participation, this qualitative study explored and compared adolescents’ (15-17 years old) and young women’s (18-21 years old) perceptions of HIV risk, their perspectives on clinical trial participation, and their understanding of research trial concepts. Multiple in-depth interviews were conducted with 10 adolescent girls (age 15-17) and 11 young women (age 18-21) who were currently sexually active in Dar es Salaam, Tanzania. With similar socio-demographic characteristics and relationship patterns, adolescent girls were less certain about their own HIV risk compared to the young women who more readily recognized their risk. Regarding trial participation, participants in both groups largely did not have logistical concerns, rather they recognized benefits from trial participation, although they had a concern about the recommended condom use. In terms of research concepts, both the adolescent girls and the young women had a hard time understanding them, particularly the concept of placebos. More broadly, the adolescent girls believed they should be included in clinical trials and that they are able to provide informed consent without parental consent. Compared to the young women, adolescent girls had lower perceived HIV risk, similar understandings of research concepts, and higher acceptability of adolescent trial participation without parent consent (although they supported parental/guardian involvement). Even though adolescent girls seem to have potential acceptability and readiness to participate in clinical trials, meaningful modification may be required for the adolescent inclusion in such trials in order to enhance understanding of research concepts, minimize preventive misconceptions and improve the informed consent process to include parental inclusion if not consent.

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Jeon, Harum (2021). Adolescents’ and young women’s perspectives on participation in biomedical clinical trials for HIV prevention products in Tanzania. Master's thesis, Duke University. Retrieved from https://hdl.handle.net/10161/23135.

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