Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men
|ClinicalTrials.gov Identifier: NCT00856323|
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : November 27, 2012
Last Update Posted : September 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|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)|
|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|
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 Name: Emtricitabine and tenofovir disoproxil fumarate
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
- 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).
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|