Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men
Condition: Amphetamine-Related Disorders; HIV; HIV Infections
MeSH terms: Amphetamine-Related Disorders
Intervention: Truvada; CM
Intervention description: At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).; Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites.
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Methamphetamine; HIV; Post-exposure prophylaxis; HIV seronegativity

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.
    

Eligibility 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.