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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Biobehavioral Interventions for HIV-negative Methamphetamine-using MSM

Brief 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.

Detailed Summary: At the baseline, all eligible participants underwent informed consent; completed baseline assessments; received rapid HIV testing; provided specimens for syphilis, gonorrhea and chlamydia testing; and received a medical examination. Those who reported a high-risk sexual or drug exposure episode with an HIV-positive or serostatus-unknown source within the preceding 72 hours immediately initiated postexposure prophylaxis. All other participants received a 4-day ''starter pack'' of Truvada to be initiated only in the case of a future high-risk exposure to HIV. All participants began the voucher-based CM intervention upon study entry. For the initial 8 weeks of study conduct, participants presented to the study site three times weekly for a urine drug screen for methamphetamine metabolites. Participants who provided urine samples that were negative for methamphetamine metabolites earned vouchers, which escalated in value for successive negative urine samples. A participant with a missing sample or a sample positive for methamphetamine metabolites did not earn vouchers. Accrued vouchers were never forfeited and could be redeemed at any time during the study for gift certificates or goods or services that promote healthy, pro-social behaviors; vouchers could not be redeemed for cash.
Sponsor: Friends Research Institute, Inc.

Current Primary Outcome: Self-reported Methamphetamine Use in Previous 30 Days. [ Time Frame: 3-months after baseline ]

Mean number of days (of the past 30) of methamphetamine use.


Original Primary Outcome: Decrease in self-reported methamphetamine use in previous 30 days. [ Time Frame: 3-months after baseline ]

Current Secondary Outcome:

  • Description of Incident STI Infections. [ Time Frame: Baseline and 3-months ]
    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 ]
    Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.
  • Post-Exposure Prophylaxis Medication Adherence [ Time Frame: 28-days ]
    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).


Original Secondary Outcome:

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


Information By: Friends Research Institute, Inc.

Dates:
Date Received: March 3, 2009
Date Started: January 2009
Date Completion:
Last Updated: August 12, 2016
Last Verified: August 2016