Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study seeks to decrease methamphetamine use and concomitant high-risk sexual behaviors among methamphetamine-using men who have sex with men (MSM) by combining a biomedical intervention with a behavioral intervention. The behavioral intervention will consist of an 8-week course of contingency management (CM) through which participants will be reinforced for testing negative for methamphetamine metabolites during periodic urine analyses. The biomedical intervention involves a 28-day course of an antiretroviral drug (Truvada) to be administered after an unanticipated HIV risk exposure (i.e., engaging in either receptive or insertive anal sex without a condom with someone who is HIV-positive or of unknown status). In combining these two interventions, this study seeks to evaluate the combined intervention's effects on sexual risk behaviors and methamphetamine use.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Friends Research Institute, Inc.
• Collaborator: University of California, Los Angeles
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Methamphetamine; Tenofovir

Criteria

Inclusion Criteria:

• Individual must identify as a male who has sex with other men (MSM);

• At least 18 years of age;

• HIV negative serostatus on baseline rapid oral HIV antibody test;

• Self-reported methamphetamine use within the previous 72 hours and test positive for methamphetamine metabolites at baseline;

• Self-reported unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months;

• Self-reports no previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine);

• Willing to comply with study requirements (i.e., monitored urine testing three times per week, meet with physician within first week of enrollment, begin medication immediately following an unexpected high-risk sexual exposure, and contact the clinic and meet with physician within 92 hours of unexpected high-risk sexual exposure).

Exclusion Criteria:

• Does not identify as a male who has sex with other men;

• Under 18 years of age;

• HIV positive, by self-report or as indicated by the results on the baseline rapid oral HIV antibody test;

• Self-reports any previous hypersensitivity to any of the components of Truvada;

• Has not used methamphetamine in the previous 72 hours and does not test positive for methamphetamine metabolites;

• Has not had unprotected anal intercourse with an HIV-positive or status unknown partner within the previous 3 months;

• Unwilling to comply with study requirements.