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
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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
  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.


Participant Flow:   Overall Study
    PEP/CM  
STARTED     53  
COMPLETED     51  
NOT COMPLETED     2  
Withdrawal by Subject                 2  



  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.
No text entered.

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

Measure Type Primary
Measure Title Self-reported Methamphetamine Use in Previous 30 Days.
Measure Description Mean number of days (of the past 30) of methamphetamine use.
Time Frame 3-months after baseline  
Safety Issue Yes  

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.
53 enrolled and 2 were withdrawn.

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.


Measured Values
    PEP/CM  
Number of Participants Analyzed  
[units: participants]
  51  
Self-reported Methamphetamine Use in Previous 30 Days.  
[units: days]
Mean ± Standard Deviation
  1.6  ± 2.4  

No statistical analysis provided for Self-reported Methamphetamine Use in Previous 30 Days.



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

Measure Type Secondary
Measure Title Description of Incident STI Infections.
Measure Description Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.
Time Frame Baseline and 3-months  
Safety Issue Yes  

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.
53 enrolled and 2 were withdrawn.

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.


Measured Values
    PEP/CM  
Number of Participants Analyzed  
[units: participants]
  51  
Description of Incident STI Infections.  
[units: Proportion of Participants]
Mean ( Full Range )
  .074  
  ( .045 to .114 )  

No statistical analysis provided for Description of Incident STI Infections.



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

Measure Type Secondary
Measure Title HIV-related Sexual Risk Behaviors in Previous 30 Days.
Measure Description Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.
Time Frame 3-months after baseline  
Safety Issue Yes  

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.
53 enrolled and 2 were withdrawn.

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.


Measured Values
    PEP/CM  
Number of Participants Analyzed  
[units: participants]
  51  
HIV-related Sexual Risk Behaviors in Previous 30 Days.  
[units: episodes]
Mean ± Standard Deviation
  .44  ± 1.4  

No statistical analysis provided for HIV-related Sexual Risk Behaviors in Previous 30 Days.



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

Measure Type Secondary
Measure Title Post-Exposure Prophylaxis Medication Adherence
Measure Description Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed).
Time Frame 28-days  
Safety Issue Yes  

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.
35 participants initiated PEP

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.


Measured Values
    PEP/CM  
Number of Participants Analyzed  
[units: participants]
  35  
Post-Exposure Prophylaxis Medication Adherence  
[units: proportional medication adherence]
Median ( Inter-Quartile Range )
  0.96  
  ( 0.57 to 1.0 )  

No statistical analysis provided for Post-Exposure Prophylaxis Medication Adherence




  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