Effects of Contingency Management for Methamphetamine Abstinence on Post-Exposure Prophylaxis for HIV in Men Who Have Sex With Men (MSM)
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.
|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|
- 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.
- 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).
|Study Start Date:||January 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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 Names: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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|