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
|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).
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|