500
Participants
Start Date
May 15, 2018
Primary Completion Date
December 21, 2023
Study Completion Date
December 21, 2023
FTC/TDF and DMPA
The primary analysis will be separate comparisons of the annualized rates of change in BMD and TBS of the spine and hip between women using PrEP and DMPA concurrently versus women using DMPA only (comparison 1), women using PrEP only (comparison 2), and women using neither (comparison 3). Analyses will account for baseline BMD.
FTC/TDF
The primary analysis will be separate comparisons of the annualized rates of change in BMD and TBS of the spine and hip between women using PrEP and DMPA concurrently versus women using DMPA only (comparison 1), women using PrEP only (comparison 2), and women using neither (comparison 3). Analyses will account for baseline BMD.
DMPA
The primary analysis will be separate comparisons of the annualized rates of change in BMD and TBS of the spine and hip between women using PrEP and DMPA concurrently versus women using DMPA only (comparison 1), women using PrEP only (comparison 2), and women using neither (comparison 3). Analyses will account for baseline BMD.
Neither DMPA nor FTC/TDF
The primary analysis will be separate comparisons of the annualized rates of change in BMD and TBS of the spine and hip between women using PrEP and DMPA concurrently versus women using DMPA only (comparison 1), women using PrEP only (comparison 2), and women using neither (comparison 3). Analyses will account for baseline BMD.
Infectious Disease Institute, Kampala
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Makerere University
OTHER
MU-JHU CARE
OTHER
Columbia University
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
University of Washington
OTHER