Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00856323
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : November 27, 2012
Last Update Posted : September 20, 2016
University of California, Los Angeles
Information provided by (Responsible Party):
Friends Research Institute, Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Amphetamine-Related Disorders
HIV Infections
Interventions: Drug: Truvada
Behavioral: CM

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between March 2009 and August 2010, 358 individuals inquired about the study on the basis of recruitment efforts, 64 presented for screening, and 53 participants enrolled in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Reasons for Screen Failure (N = 7): HIV-positive at baseline screening; negative urine screen for methamphetamine§; did not complete baseline assessments; provided incorrect information at phone screening.

Reporting Groups

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).

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.

Participant Flow:   Overall Study
Withdrawal by Subject                2 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   Self-reported Methamphetamine Use in Previous 30 Days.   [ Time Frame: 3-months after baseline ]

2.  Secondary:   Description of Incident STI Infections.   [ Time Frame: Baseline and 3-months ]

3.  Secondary:   HIV-related Sexual Risk Behaviors in Previous 30 Days.   [ Time Frame: 3-months after baseline ]

4.  Secondary:   Post-Exposure Prophylaxis Medication Adherence   [ Time Frame: 28-days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Cathy Reback
Organization: Friends Research Institute, Inc.
phone: 323-463-1601

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Friends Research Institute, Inc. Identifier: NCT00856323     History of Changes
Other Study ID Numbers: 702632
First Submitted: March 3, 2009
First Posted: March 5, 2009
Results First Submitted: August 27, 2012
Results First Posted: November 27, 2012
Last Update Posted: September 20, 2016