Biobehavioral Interventions for HIV-negative, Stimulant Using Men Who Have Sex With Men

March 13, 2025 updated by: Friends Research Institute, Inc.

Optimizing Access to Non-occupational Post Exposure Prophylaxis for HIV Using Contingency Management in Stimulant-Using Men Who Have Sex With Men

This study seeks to evaluate the efficacy of a contingency management (CM) intervention compared to a yoked control condition for eliminating illicit stimulant use and for decreasing time to initiating post exposure prophylaxis (PEP), for improving adherence to PEP, and for completing PEP following a potential HIV-exposure event. Men who have sex with men who use cocaine amphetamine or methamphetamine frequently also have high risk sexual behaviors during or after their drug use. The objective of this study evaluates whether the use of CM that targets stimulant use significantly aids men who have sex with men who use stimulants and also engage in high-risk sexual transmission behaviors to be able to initiate, adhere to and complete PEP, thereby optimizing the utility of a biomedical HIV prevention intervention for reducing HIV incidence in this very high-risk group of MSM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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;

and,

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.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90028
        • Friends Community Center, A Division of Friends Research Institute, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male who has sex with other men (MSM) by self-report
  • At least 18 years of age
  • HIV-negative serostatus on baseline rapid oral HIV antibody test, and no signs or symptoms consistent with primary HIV infection (PHI)
  • Self-reported stimulant use within the previous 30 days
  • Self-report of unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months
  • Self-report of no previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine)
  • In the opinion of the study medical provider, no contraindication to PEP medication treatment (laboratory testing, medical/drug interaction, or other)
  • Has not used PEP in the previous 6 months
  • A current resident of Los Angeles County
  • Does not have a plan to move away from Los Angeles County in the next 6 months
  • Willing and able to provide informed consent
  • Willing and able to comply with study requirements

Exclusion Criteria:

  • Does not identify as a male who has sex with other men
  • Under 18 years of age
  • HIV positive by self-report or as indicated by the results on baseline rapid oral HIV antibody testing
  • Has not used a stimulant in the previous 30 days by self-report
  • Has not had unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months
  • Creatinine clearance <30 ml/min and not on dialysis
  • Self-reports any previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine);
  • In the opinion of the study medical provider, there exists a contraindication to administering Truvada-based post-exposure prophylaxis (laboratory testing, medical/drug interaction, or other)
  • Has used PEP in the previous six months
  • Not a current resident of Los Angeles County
  • Unwilling or unable to provide informed consent
  • Unwilling or unable to comply with study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Drug: Truvada
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 Names:
  • 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.

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).
Drug: Truvada
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 Names:
  • Tenofovir/emtricitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From Exposure to Truvada Initiation
Time Frame: 6-month follow-up
Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.
6-month follow-up
Medication Adherence
Time Frame: Daily throughout medication course
Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.
Daily throughout medication course
Course Completion
Time Frame: 28-days post initiation
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.
28-days post initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)
Time Frame: Thrice-weekly for 8 weeks
Abstinence will be measured using thrice weekly urine drug screens and self-report
Thrice-weekly for 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Friends Research Institute, Inc.

Collaborators

University of California, Los Angeles

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 8, 2010

First Submitted That Met QC Criteria

June 9, 2010

First Posted (Estimated)

June 10, 2010

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC08-LA-710-FRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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