The Kampala Women's Bone Study
Summary
The primary objective of this study is to address critical safety questions with concurrent TDF-based PrEP and DMPA use. We hypothesize that young women using TDF-based PrEP and DMPA will have lower bone acquisition and altered bone metabolism. Bone mineral metabolism is in part regulated by the kidney, and we hypothesize that bone effects from concurrent PrEP and DMPA use will be driven by subclinical kidney injury, a known side effect of TDF, as well as DMPA-induced hypoestrogenism. To investigate our hypothesis, we will enroll a prospective cohort of approximately 500 HIV-uninfected women ages 16-25 years in Kampala, Uganda who have substantial HIV risk and are initiating DMPA or barrier method contraception. Over a 24-month period, we will offer TDF-based PrEP. We will use state-of-the-art radiologic, biochemical, and epidemiologic methods to test the hypothesis that concurrent TDF-based PrEP and DMPA use results in compounding adverse effects on bone health.
Timeline
- Start
- 2018-05-15
- Primary completion
- 2023-12-21
- Completion
- 2023-12-21
Publications
- Wu L, Ssebuliba T, Muwonge TR, Bambia F, Stein G, Nampewo O, Sapiri O, Goetz BJ, Penrose KJ, Parikh UM, Mujugira A, Heffron R. Alignment of PrEP Use With Potential HIV Exposure in Young Women and Men in Uganda. J Acquir Immune Defic Syndr. 2025 Apr 1;98(4):326-333. doi: 10.1097/QAI.0000000000003573. Epub 2025 Feb 19.
- Zia Y, Nambala L, Stalter RM, Muwonge TR, Ssebuliba T, Nakyanzi A, Nampewo O, Boyer J, Morrison S, Nsubuga R, Bagaya M, Nyanzi R, Matovu F, Yin M, Wyatt C, Mujugira A, Heffron R for the Kampala Women's Bone Study. Depression and PrEP uptake, interruption, and adherence among young women in Uganda. AIDS Care. 2023 Sep;35(9):1365-1374. doi: 10.1080/09540121.2023.2177250. Epub 2023 Mar 9.