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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00856323
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : November 27, 2012
Last Update Posted : September 20, 2016
University of California, Los Angeles
Information provided by (Responsible Party):
Friends Research Institute, Inc.

March 3, 2009
March 5, 2009
August 27, 2012
November 27, 2012
September 20, 2016
January 2009
December 2010   (Final data collection date for primary outcome measure)
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.
Decrease in self-reported methamphetamine use in previous 30 days. [ Time Frame: 3-months after baseline ]
Complete list of historical versions of study NCT00856323 on Archive Site
  • 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).
  • 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 ]
Not Provided
Not Provided
Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men
Biobehavioral Interventions for HIV-negative Methamphetamine-using MSM
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.
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.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • 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 Name: 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 Name: Contingency Management
Experimental: PEP/CM
Participants are provided contingency management vouchers for methamphetamine abstinence, and can initiate postexposure prophylaxis (Truvada; 1 pill daily for 28 days) after non-occupational exposure to HIV.
  • Drug: Truvada
  • Behavioral: CM

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: No
Friends Research Institute, Inc.
Friends Research Institute, Inc.
University of California, Los Angeles
Principal Investigator: Cathy J Reback, Ph.D. Friends Research Institute, Inc.
Principal Investigator: Raphael J Landovitz, M.D. UCLA Center for Clinical AIDS Research and Education
Principal Investigator: Steve Shoptaw, Ph.D. UCLA Department of Family Medicine
Friends Research Institute, Inc.
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP