Phase 2
N=53
Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men
Amphetamine-Related Disorders · HIV · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00856323 ↗Enrolled (actual)
53
Serious AEs
3.8%
Results posted
Nov 2012
Primary outcome: Primary: Self-reported Methamphetamine Use in Previous 30 Days. — 1.6 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Truvada (Drug); CM (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Friends Research Institute, Inc.
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-reported Methamphetamine Use in Previous 30 Days. |
1.6 | — |
| SECONDARY Description of Incident STI Infections. |
.074 | — |
| SECONDARY HIV-related Sexual Risk Behaviors in Previous 30 Days. |
.44 | — |
| SECONDARY Post-Exposure Prophylaxis Medication Adherence |
0.96 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00856323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.