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

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:
NCT01140880
First received: June 8, 2010
Last updated: June 27, 2014
Last verified: May 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: HIV Seroconversion
Stimulant Abuse
Intervention: Drug: Truvada

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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).

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.

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).


Participant Flow:   Overall Study
    Contingency Management     Yoked Contingency Management  
STARTED     70     100  
COMPLETED     56     56  
NOT COMPLETED     14     44  
Death                 0                 1  
Withdrawal by Subject                 6                 3  
Lost to Follow-up                 8                 10  
Protocol Violation                 0                 30  



  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.
170 participants enrolled. 30 participants in the Yoked Contingency Management arm were involved in a protocol violation that rendered their data unusable. An additional 14 participants from each arm were either withdrawn, died (n = 1, not study related), or were lost to follow-up. Thus, baseline N = 140 (70/70), and follow-up N = 112 (56/56).

Reporting Groups
  Description
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.

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).

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.

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).

Total Total of all reporting groups

Baseline Measures
    Contingency Management     Yoked Contingency Management     Total  
Number of Participants  
[units: participants]
  70     70     140  
Age  
[units: years]
Mean ± Standard Deviation
  35.8  ± 10.3     37.9  ± 11.8     36.8  ± 11.1  
Gender  
[units: participants]
     
Female     0     0     0  
Male     70     70     140  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian/white     27     25     52  
African American/black     27     25     52  
Native American     1     3     4  
Asian/Pacific Islander     2     1     3  
Hispanic/Latino     11     14     25  
Multiracial/Other     2     2     4  
Region of Enrollment  
[units: participants]
     
United States     70     70     140  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time From Exposure to Truvada Initiation   [ Time Frame: 6-month follow-up ]

2.  Primary:   Medication Adherence   [ Time Frame: Daily throughout medication course ]
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Measure Type Primary
Measure Title Medication Adherence
Measure Description Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.
Time Frame Daily throughout medication course  
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.
40 participants initiated Truvada, of which 30 had evaluable medication adherence and course completion data (the 10 others were involved in the protocol violation).

Reporting Groups
  Description
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.

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).

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.

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).


Measured Values
    Contingency Management     Yoked Contingency Management  
Number of Participants Analyzed  
[units: participants]
  17     13  
Medication Adherence  
[units: proportion]
  0.75     0.45  

No statistical analysis provided for Medication Adherence



3.  Primary:   Course Completion   [ Time Frame: 28-days post initiation ]

4.  Secondary:   Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)   [ Time Frame: Thrice-weekly for 8 weeks ]


  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 J. Reback
Organization: Friends Research Institute, Inc.
phone: 323-463-1601
e-mail: reback@friendsresearch.org


No publications provided


Responsible Party: Cathy Reback, Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01140880     History of Changes
Other Study ID Numbers: MC08-LA-710-FRI
Study First Received: June 8, 2010
Results First Received: May 27, 2014
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration