Biobehavioral Interventions for HIV-negative, Stimulant Using Men Who Have Sex With Men
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Optimizing Access to Non-occupational Post Exposure Prophylaxis for HIV Using Contingency Management in Stimulant-Using Men Who Have Sex With Men|
- Time From Exposure to Truvada Initiation [ Time Frame: 6-month follow-up ] [ Designated as safety issue: Yes ]Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.
- Medication Adherence [ Time Frame: Daily throughout medication course ] [ Designated as safety issue: Yes ]Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.
- Course Completion [ Time Frame: 28-days post initiation ] [ Designated as safety issue: Yes ]PEP course completion is a dichotomous variable (0 = Not completed; 1 = Completed) that indicates whether the participant maintained sufficient adherence to the Truvada regimen to receive all 28 doses of the medication. Note: Missing 3 Truvada doses in a row terminated the PEP-intervention and prevented Course Completion.
- Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine) [ Time Frame: Thrice-weekly for 8 weeks ] [ Designated as safety issue: Yes ]Abstinence will be measured using thrice weekly urine drug screens and self-report
|Study Start Date:||May 2010|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Contingency Management
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 stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.
Participants reporting recent (i.e., < 48 hours) exposure to HIV viral inoculum will have the opportunity to initiate Truvada (1 pill daily for 28 days).
Truvada 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: Tenofovir/emtricitabine
Sham Comparator: Yoked Contingency Management
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 stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.
Other Name: Tenofovir/emtricitabine
This was a prospective, randomized study. 170 participants who met inclusion and exclusion criteria were randomized to CM or NCYC (non-contingent yoked-control condition) arms. They were provided with a 4-day starter-pack of PEP medication (tenofovir + emtricitabine, Truvada) to be started only in the event of a high-risk sexual exposure. The two interventions were implemented simultaneously:
The CM or NCYC intervention, remunerating (via vouchers) the participant based on his own (CM) or a yoked-participant's (NCYC) stimulant-metabolite-free urine samples for 8 weeks;
Post-exposure prophylaxis, providing risk reduction counseling, adherence counseling and PEP medication for 28 days in the event of a high-risk sexual exposure to HIV.
All participants were followed for 24 weeks, or 24-weeks post-HIV-exposure, whichever was longer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140880
|United States, California|
|Friends Community Center, A Division of Friends Research Institute, Inc.|
|Los Angeles, California, United States, 90028|
|Principal Investigator:||Cathy J. Reback, Ph.D.||Friends Research Institute, Inc.|
|Principal Investigator:||Raphael J. Landovitz, M.D., M.Sc.||UCLA Center for Clinical AIDS Research and Education|
|Principal Investigator:||Steven Shoptaw, Ph.D.||UCLA Department of Family Medicine|