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

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00856323
First received: March 3, 2009
Last updated: August 12, 2016
Last verified: August 2016
History of Changes
  Purpose
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.

Condition Intervention Phase
Amphetamine-Related Disorders
HIV
HIV Infections
 Drug: Truvada
Behavioral: CM
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Biobehavioral Interventions for HIV-negative Methamphetamine-using MSM

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Friends Research Institute, Inc.:

Primary Outcome Measures:
  • Self-reported Methamphetamine Use in Previous 30 Days. [ Time Frame: 3-months after baseline ] [ Designated as safety issue: Yes ]
    Mean number of days (of the past 30) of methamphetamine use.


Secondary Outcome Measures:
  • 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).
Enrollment: 53
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Detailed Description:
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.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856323

Locations
United States, California
Friends Community Center
Los Angeles, California, United States, 90028
Sponsors and Collaborators
Friends Research Institute, Inc.
University of California, Los Angeles
Investigators
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
  More Information

Publications:

Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00856323     History of Changes
Other Study ID Numbers: 702632 
Study First Received: March 3, 2009
Results First Received: August 27, 2012
Last Updated: August 12, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Friends Research Institute, Inc.:
Methamphetamine
HIV
Post-exposure prophylaxis
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Amphetamine-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Tenofovir
Emtricitabine
 Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Methamphetamine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 27, 2016