The antiretroviral medication Truvada was recently approved by the FDA as a pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection among high risk uninfected individuals. A primary concern of PrEP as a prevention strategy is risk compensation, where PrEP users increase their risky sexual behaviors believing they can no longer be infected. Although the results from the PrEP efficacy trials did not find changes in risk behavior, it remains unclear how, and in what ways, rates of risky sex will change now that that Truvada is FDA approved. We propose to 1) examine sexual risk compensation over 12 months among men who have sex with men (MSM) who are initiating PrEP in a funded implementation study focused on PrEP adherence, and 2) enroll a control group of non-PrEP high risk MSM to compare sexual risk behaviors with the PrEP group over 6-months. By leveraging a currently funded PrEP demonstration cohort and adding a non-PrEP control group for comparison, this study will provide valuable information regarding risk compensation in a timely and cost-effective manner. Results will give physicians and health care administrators evidence to guide policies concerning PrEP usage, appropriate behavioral counseling strategies, and support for patient engagement and education for their health care.

Public Health Relevance

The HIV antiretroviral medication Truvada was recently approved by the FDA as a pre-exposure prophylaxis (PrEP) to prevent HIV infection among high risk uninfected individuals. It is unknown whether the use of PrEP in practice will lead to risk compensation, where PrEP users increase their risky sexual behaviors and reduce the effectiveness of PrEP. This study will examine sexual risk behaviors (up to 12 months) among HIV negative men who have sex with men (MSM) who are, and who are not, initiating PrEP use. Results will inform policies concerning PrEP usage and related behavioral counseling strategies.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21MH100979-01A1
Application #
8603501
Study Section
Behavioral and Social Science Approaches to Preventing HIV/AIDS Study Section (BSPH)
Program Officer
Pequegnat, Willo
Project Start
2013-09-04
Project End
2015-06-30
Budget Start
2013-09-04
Budget End
2014-06-30
Support Year
1
Fiscal Year
2013
Total Cost
$177,561
Indirect Cost
$59,819
Name
University of Southern California
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
072933393
City
Los Angeles
State
CA
Country
United States
Zip Code
90089