PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples

Completed

Conditions studied: PrEP for Conception Purposes

In brief

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).

Key facts

Study ID

NCT02233192

Run by

Boston Medical Center

People needed

50

Starts

2014-07-01

Expected to finish

2017-06-15

Last updated by the study team

2017-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Between the ages of 18 to 40 years
• In relationship with HIV-positive male
• Chosen to take PrEP for conception after completing counseling with health care provider

You may not qualify if…

• HIV-positive
• In relationship with HIV-negative female
• Partner has chosen to take PrEP for conception after completing counseling with health care provider

Where it is running

• Northwestern University — Chicago, Illinois, United States
• The Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Drexel University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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