PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples
Status:Ongoing
Phase:Open Label
Principal Investigator(s):Meg Sullivan
Objective:The purpose of this study is to observe patient response to current clinical practice utilizing TRUVADA (emtricitabine and tenofovir disoproxil fumarate) for Pre-Exposure Prophylaxis (PrEP) amongst HIV serodiscordant couples desiring to conceive across four U.S. cities that are currently offering this method as standard of care. This study is an observational cohort study, which will test the feasibility and acceptability of PrEP for conception, while examining the challenges and generalizability of this current medical practice. The CDC recently released formal clinical practice guidelines for the use of PrEP in the United States. For high-risk serodiscordant heterosexual couples using PrEP during conception, the guidelines state, "PrEP use periconception and during pregnancy by the uninfected partner may offer an additional tool to reduce the risk of sexual HIV acquisition. Both the FDA labeling information and the perinatal antiretroviral treatment guidelines permit this use" (CDC 2014).
Prevention Option(s):PrEP
Study Design:
Start Date
End Date
July 1, 2014
July 1, 2016
Enrollment:32
Age range:
18 Years ↔
any
Population:Cisgender Men, Cisgender Women