Optimizing Access to Non-occupational Post Exposure Prophylaxis for HIV Using Contingency Management in Stimulant-Using Men Who Have Sex with Men (lay title: Friends Care 2)
Co-Principal Investigator: Raphael J. Landovitz, M.D., MSC (UCLA)
Funded By: California HIV/AIDS Research Programs
Grant #: MC08-LA-710
Total Project Period: 4/1/09 - 3/31/13
The majority of new HIV infections in Los Angeles County continues to be found among men who have sex with men (MSM). Within MSM, stimulant use, particularly methamphetamine use, is a major factor in driving new infections, primarily via sexual disinhibitions that correspond to the commission of extremely high-risk sexual transmission behaviors. Friends Care is a randomized, controlled trial to evaluate the efficacy of voucher-based contingency management for optimizing PEP among stimulant-using MSM. The study seeks to determine the efficacy of voucher-based contingency management in high-risk, HIV negative stimulant-using MSM for: 1) Increasing the rate of appropriate PEP use after a potential HIV exposure; 2) Decreasing time to initiation of appropriate PEP use after a potential HIV exposure; and 3) Maximizing adherence to and completion of the 28-day course of PEP medication. The objective of the study is to evaluate whether the use of CM, a potent behavioral intervention for reducing stimulant use, assists MSM who use stimulants and engage in high-risk sexual transmission behaviors to be able to initiate, adhere to and complete PEP, thereby optimizing the utility of a biomedical HIV prevention intervention for reducing HIV incidence in this very high-risk group of MSM. Friends Care is a 2-group, parallel group design that will randomize 165 non-treatment-seeking, stimulant-using, HIV-negative MSM actively engaging in unprotected anal sex with status-unknown or HIV-positive men into one of two conditions: (1) CM of stimulant use, which will utilize an escalating schedule of voucher-based reinforcement therapy for thrice weekly provision of stimulant-negative urine samples; or (2) a control condition that yokes each control subject to an index subject in the CM condition such that the yoked control receives vouchers in non-contingent fashion, but at an identical rate and amount to those earned by their yoked index subject. All subjects will receive a 4-day starter pack of PEP medication to facilitate initiation of PEP following a potential exposure event. Once PEP is started, subjects return to clinic to receive clinical evaluation and the complement of 24 days of medication. Follow-up visits are conducted at the end of 8 weeks and at 3- and 6-months after baseline to measure PEP initiation, PEP adherence, PEP completion, and incident HIV and STI infections.