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

NCT00856323 | Completed Phase 2 Results DMC

• 1 other identifier: 702632
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Amphetamine-Related Disorders; HIV; HIV Infections

Keywords

Methamphetamine; HIV; Post-exposure prophylaxis; HIV seronegativity

Outcome Measures

Primary Outcomes (1)

• Self-reported Methamphetamine Use in Previous 30 Days.

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

  3-months after baseline

Secondary Outcomes (3)

• Description of Incident STI Infections.

  Baseline and 3-months

• HIV-related Sexual Risk Behaviors in Previous 30 Days.

  3-months after baseline

• Post-Exposure Prophylaxis Medication Adherence

  28-days

Study Arms (1)

PEP/CM

EXPERIMENTAL

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

Interventions

Truvada DRUG

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

Also known as: Emtricitabine and tenofovir disoproxil fumarate

PEP/CM

CM BEHAVIORAL

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.

Also known as: Contingency Management

PEP/CM

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Friends Community Center

Los Angeles, California, 90028, United States

Location

Related Publications (2)

• Landovitz RJ, Fletcher JB, Inzhakova G, Lake JE, Shoptaw S, Reback CJ. A novel combination HIV prevention strategy: post-exposure prophylaxis with contingency management for substance abuse treatment among methamphetamine-using men who have sex with men. AIDS Patient Care STDS. 2012 Jun;26(6):320-8. doi: 10.1089/apc.2011.0432.

  PMID: 22680280 RESULT

• Fletcher JB, Rusow JA, Le H, Landovitz RJ, Reback CJ. High-risk Sexual Behavior is Associated with Post-Exposure Prophylaxis Non-adherence among Men who have Sex with Men Enrolled in a Combination Prevention Intervention. J Sex Transm Dis. 2013;2013:210403. doi: 10.1155/2013/210403.

  PMID: 24527254 DERIVED

MeSH Terms

Conditions

Amphetamine-Related Disorders; HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Tenofovir

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Cathy Reback
• Organization: Friends Research Institute, Inc.

reback@friendsresearch.org

323-463-1601

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 5, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 20, 2016
• Results First Posted: November 27, 2012

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)