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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.
ClinicalTrials.gov Identifier: NCT00856323
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : November 27, 2012
Last Update Posted : September 20, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

  Participant Flow


  Baseline Characteristics

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 
Overall Participants Analyzed 
[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

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
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  More Information