Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men
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ClinicalTrials.gov Identifier: NCT00856323 |
Recruitment Status
:
Completed
First Posted
: March 5, 2009
Results First Posted
: November 27, 2012
Last Update Posted
: September 20, 2016
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Condition or disease | Intervention/treatment | Phase |
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Amphetamine-Related Disorders HIV HIV Infections | Drug: Truvada Behavioral: CM | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Biobehavioral Interventions for HIV-negative Methamphetamine-using MSM |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |
Arm | Intervention/treatment |
---|---|
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.
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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
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- 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.
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856323
United States, California | |
Friends Community Center | |
Los Angeles, California, United States, 90028 |
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 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Friends Research Institute, Inc. |
ClinicalTrials.gov Identifier: | NCT00856323 History of Changes |
Other Study ID Numbers: |
702632 |
First Posted: | March 5, 2009 Key Record Dates |
Results First Posted: | November 27, 2012 |
Last Update Posted: | September 20, 2016 |
Last Verified: | August 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
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 |