FHI 360 is conducting a ground-breaking study, “Adolescent Women and Microbicide Trials: Assessing the Opportunities and Challenges of Participation,” in India and Tanzania among young women ages 15–21. Women need new HIV prevention methods, including oral and topical microbicides, that they control to reduce their vulnerability to HIV. However, adolescent girls are often excluded from studies of these methods, and regulatory bodies are unlikely to allow these methods to be marketed to adolescents without research on the effectiveness and acceptability of microbicides among this age group.
To address the challenges in recruiting and retaining young women in HIV prevention trials, FHI 360’s multiphase study aims to: (1) explore the differences in HIV risk among girls ages 15–17 versus those ages 18–21; (2) evaluate the factors that lead to the exclusion of adolescent girls from HIV prevention trials; (3) examine girls’ understanding of research concepts and ability to adhere to clinical trial requirements, and (4) determine the acceptability of microbicide use among this population. Study methods include formative qualitative research in both India and Tanzania and a mock clinical trial in Tanzania. When the study is done, researchers will recommend whether or how trials on microbicides and other HIV prevention methods should be adapted to include adolescent participants. This study is one step toward increasing adolescent girls’ autonomy and decreasing their risk of HIV.