Effects of Contingency Management for Methamphetamine Abstinence on Post-Exposure Prophylaxis for HIV in Men Who Have Sex With Men (MSM)

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Cathy Reback, Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00856323
First received: March 3, 2009
Last updated: November 27, 2012
Last verified: August 2012
Results First Received: August 27, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Amphetamine-Related Disorders
HIV
HIV Infections
Interventions: Drug: Truvada
Behavioral: CM

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
PEP/CM

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.


Baseline Measures
    PEP/CM  
Number of Participants  
[units: participants]
  53  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     53  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  36.1  ± 7.9  
Gender  
[units: participants]
 
Female     0  
Male     53  
Region of Enrollment  
[units: participants]
 
United States     53  



  Outcome Measures
  Show All 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
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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
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  More Information
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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
e-mail: reback@friendsresearch.org


Publications of Results:

Responsible Party: Cathy Reback, Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00856323     History of Changes
Other Study ID Numbers: 702632
Study First Received: March 3, 2009
Results First Received: August 27, 2012
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration