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

Sponsor:	Friends Research Institute, Inc.
Information provided by:	Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:	NCT00856323

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 II

Study Type:	Interventional
Study Design:	Prevention, Open Label, Single Group Assignment, Safety Study
Official Title:	Biobehavioral Interventions for HIV-Negative Methamphetamine-Using MSM

Resource links provided by NLM:

MedlinePlus related topics: AIDS Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada Amphetamine Methamphetamine

U.S. FDA Resources

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

Primary Outcome Measures:

Decrease in self-reported methamphetamine use in previous 30 days. [ Time Frame: 3-months after baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PEP/CM: Experimental	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). 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.

Eligibility

Ages Eligible for Study:	18 Years and older
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

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

Contacts

Contact: Galina Inzhakova, MPH	323-512-7014	ginzhakova@friendsresearch.org
Contact: Thomas Rastrelli	323-463-1601	trastrelli@friendsresearch.org

Locations

United States, California
Friends Community Center	Recruiting
Los Angeles, California, United States, 90028
Contact: Galina Inzhakova, MPH 323-512-7014 ginzhakova@friendsresearch.org
Contact: Thomas Rastrelli 323-463-1601 trastrelli@friendsresearch.org
Principal Investigator: Cathy J Reback, Ph.D.

Sponsors and Collaborators

Friends Research Institute, Inc.

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

No publications provided

Responsible Party:	Friends Research Institute, Inc. ( Cathy J. Reback )
Study ID Numbers:	702632
Study First Received:	March 3, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00856323 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Friends Research Institute, Inc.:

Methamphetamine
HIV
Post-exposure prophylaxis
HIV seronegativity

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Anti-Infective Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Disorders of Environmental Origin
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Emtricitabine

Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Sympathomimetics
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Central Nervous System Stimulants
Antiviral Agents

ClinicalTrials.gov processed this record on February 08, 2010