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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Washington
Collaborators:
Columbia University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Icahn School of Medicine at Mount Sinai Makerere University Makerere University-Johns Hopkins University Research Collaboration MU-JHU CARE
Treatments:
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination