Optimizing Access to Non-occupational Post Exposure Prophylaxis for HIV Using Contingency Management in Stimulant-Using Men Who Have Sex with Men (Friends Care 2)
|Principal Investigator:||Cathy J. Reback, Ph.D.|
|Co-Investigator:||Raphael Landovitz, M.D. (UCLA)|
|Co-Investigator:||Steven Shoptaw, Ph.D.|
|Program Coordinator:||Jesse Fletcher, Ph.D.|
|Funded by:||California HIV/AIDS Research Programs|
|Total Project Period:||4/09-3/13|
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.
Voucher-based Incentives in a Prevention Setting (VIPS)
|Principal Investigator:||Cathy J. Reback, Ph.D.|
|Co-Investigator:||James A. Peck, Psy.D.|
|Program Coordinator:||Rhodri Dierst-Davies, M.P.H.|
|Funded by:||National Institute on Drug Abuse|
|Grant Number:||1RO1 DA015990|
|Total Project Period:||5/04 – 4/09|
Homeless, gay and bisexual male abusers suffer approximately 80% seroprevalence and often engage in exchange sex and resist treatment for substance abuse. Contingency management interventions, which provide positive incentives for behavior change, may be particularly well suited for this disenfranchised, high-risk cohort. Specifically, voucher-based incentive therapies may be effective since they have established potency for increasing prosocial behaviors that successfully compete with taking drugs and for reducing drug use. A randomize, controlled trial assigns 130 non-treatment seeking gay, bisexual or MSM substance users to either voucher-based incentive therapy or control groups for 24 weeks, with follow-up evaluations at 7, 9 and 12 months post randomization. The voucher-based group earns vouchers in exchange for completing prosocial and healthy behaviors, and/or submitting drug-negative urine and alcohol-negative breath samples, and/or attendance in a standard HIV prevention program, OAPP-funded The G.U.Y.S. Program. The control group receives feedback regarding behaviors performed and urinalysis and breathe alcohol tests, but does not receive voucher points for these behaviors, but does receive vouchers for attendance in a standard HIV prevention program, The G.U.Y.S. Program. Vouchers are redeemable for goods located in an onsite voucher store or purchased for the participant. The study will assess the efficacy of the voucher-based intervention for increasing prosocial and healthy behavior and reducing substance abuse among these non-treatment seeking gay, bisexual and MSM substance users receiving standard HIV prevention services. The study will also assess the impact of the voucher-based incentive therapy on other measures of therapeutic change consistent with a harm reduction approach, including reduction of psychiatric symptoms, decreased injection drug use and high-risk sexual behavior, increased participation in The G.U.Y.S. Program, and improvement in different domains of overall functioning (medical/social/vocational).