Effects of Contingency Management for Methamphetamine Abstinence on Post-Exposure Prophylaxis for HIV in Men Who Have Sex With Men (MSM)

• Description of Incident STI Infections. [ Time Frame: Baseline and 3-months ] [ Designated as safety issue: Yes ]
  Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.
• HIV-related Sexual Risk Behaviors in Previous 30 Days. [ Time Frame: 3-months after baseline ] [ Designated as safety issue: Yes ]
  Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.
• Post-Exposure Prophylaxis Medication Adherence [ Time Frame: 28-days ] [ Designated as safety issue: Yes ]
  Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed).

• Decrease in incidental STI infections. [ Time Frame: Baseline and 3-months ] [ Designated as safety issue: Yes ]
• Decrease in self-reported, HIV-related sexual risk behaviors in previous 30 days. [ Time Frame: 3-months after baseline ] [ Designated as safety issue: Yes ]
• Increase medication adherence rates. [ Time Frame: 28-day drug taking period ] [ Designated as safety issue: Yes ]

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.

• Amphetamine-Related Disorders
• HIV
• HIV Infections

• Drug: Truvada
  At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
  Other Names:

  • Truvada
  • Emtricitabine and tenofovir disoproxil fumarate
• Behavioral: CM
  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.
  Other Names:

  • Contingency Management
  • CM

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.