The development of new female-initiated HIV prevention methods, including oral and topical microbicides, is urgently needed to stem the growing epidemic among adolescent women. Despite the disproportionate impact of HIV/AIDS on adolescent women, they have been markedly under-represented in HIV prevention trials. For example, only one phase III microbicide trial has attempted to recruit adolescents under the age of 18, even though sexual debut and high risk sexual behavior may occur years earlier. There are important scientific, ethical and programmatic reasons to consider recruitment of adolescent women. Nevertheless, challenges to recruiting and retaining adolescent women in HIV prevention trial research will be numerous. ? ? This proposed study will conduct formative community-level research and a pilot prospective clinic-based study in India and Tanzania to systematically examine the challenges and opportunities related to recruitment and retention of adolescent women aged 15-21 in clinical microbicide trials and make specific recommendations about whether and how such trials should be adapted to accommodate adolescent participation.
The specific aims of this study are: ? ? Aim 1: To identify the HIV risk characteristics of adolescent women and determine whether these risks differ by younger (15-17) versus older age groups (18-21) and by country context. Risk characteristics of interest include: types and patterns of sexual partnerships; types of sexual risk-taking and risk-reduction behaviors; perceptions of risk for HIV, sexually transmitted infections (STIs), and other negative health outcomes; and psychosocial and environmental factors contributing to risks; ? ? Aim 2: To evaluate the legal, socio-cultural and service delivery factors that hinder adolescent women's ? participation in microbicide trials and make specific recommendations to enhance their participation; ? ? Aim 3: To examine and compare adolescent women's (aged 15-17 and 18-21) understanding of and ability to adhere to the requirements of trial participation in the context of a prospective clinic-based study; and ? ? Aim 4: To determine adolescent women's acceptability and use of a proxy gel, including circumstances in which participants apply the gel; reasons for non-use of gel; negotiations about gel use with partners; and the influences of gel use on sexual satisfaction for themselves and their partners. ? ? ? ?
| Baumgartner, Joy Noel; Kaaya, Sylvia; Karungula, Happy et al. (2015) Domestic violence among adolescents in HIV prevention research in Tanzania: participant experiences and measurement issues. Matern Child Health J 19:33-9 |
| Tolley, Elizabeth E; Kaaya, Sylvia; Kaale, Anna et al. (2014) Comparing patterns of sexual risk among adolescent and young women in a mixed-method study in Tanzania: implications for adolescent participation in HIV prevention trials. J Int AIDS Soc 17:19149 |
