Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men
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)|
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.
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.
At the baseline, all eligible participants underwent informed consent; completed baseline assessments; received rapid HIV testing; provided specimens for syphilis, gonorrhea and chlamydia testing; and received a medical examination. Those who reported a high-risk sexual or drug exposure episode with an HIV-positive or serostatus-unknown source within the preceding 72 hours immediately initiated postexposure prophylaxis. All other participants received a 4-day ''starter pack'' of Truvada to be initiated only in the case of a future high-risk exposure to HIV. All participants began the voucher-based CM intervention upon study entry. For the initial 8 weeks of study conduct, participants presented to the study site three times weekly for a urine drug screen for methamphetamine metabolites. Participants who provided urine samples that were negative for methamphetamine metabolites earned vouchers, which escalated in value for successive negative urine samples. A participant with a missing sample or a sample positive for methamphetamine metabolites did not earn vouchers. Accrued vouchers were never forfeited and could be redeemed at any time during the study for gift certificates or goods or services that promote healthy, pro-social behaviors; vouchers could not be redeemed for cash.
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|