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

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ClinicalTrials.gov Identifier: NCT01140880
Recruitment Status : Completed
First Posted : June 10, 2010
Results First Posted : July 2, 2014
Last Update Posted : April 7, 2015
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Friends Research Institute, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions HIV Seroconversion
Stimulant Abuse
Intervention Drug: Truvada
Enrollment 170
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Contingency Management Yoked Contingency Management
Hide Arm/Group Description

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).

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).

Period Title: Overall Study
Started 70 100
Completed 56 56
Not Completed 14 44
Reason Not Completed
Death             0             1
Withdrawal by Subject             6             3
Lost to Follow-up             8             10
Protocol Violation             0             30
Arm/Group Title Contingency Management Yoked Contingency Management Total
Hide Arm/Group Description

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).

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 of all reporting groups
Overall Number of Baseline Participants 70 70 140
Hide Baseline Analysis Population Description
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).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 70 participants 140 participants
35.8  (10.3) 37.9  (11.8) 36.8  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
70
 100.0%
70
 100.0%
140
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 70 participants 70 participants 140 participants
70 70 140
1.Primary Outcome
Title Time From Exposure to Truvada Initiation
Hide Description Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.
Time Frame 6-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
40 participants with evaluable data initiated Truvada during the course of the study.
Arm/Group Title Contingency Management Yoked Contingency Management
Hide Arm/Group Description:

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).

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).

Overall Number of Participants Analyzed 26 14
Mean (Standard Deviation)
Unit of Measure: hours
32.8  (15.1) 33.0  (16.1)
2.Primary Outcome
Title Medication Adherence
Hide Description Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.
Time Frame Daily throughout medication course
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
40 participants initiated Truvada, of which 30 had evaluable medication adherence and course completion data (the 10 others were involved in the protocol violation).
Arm/Group Title Contingency Management Yoked Contingency Management
Hide Arm/Group Description:

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).

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).

Overall Number of Participants Analyzed 17 13
Measure Type: Number
Unit of Measure: proportion
0.75 0.45
3.Primary Outcome
Title Course Completion
Hide Description PEP course completion is a dichotomous variable (0 = Not completed; 1 = Completed) that indicates whether the participant maintained sufficient adherence to the Truvada regimen to receive all 28 doses of the medication. Note: Missing 3 Truvada doses in a row terminated the PEP-intervention and prevented Course Completion.
Time Frame 28-days post initiation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
40 participants initiated PEP during the study, of which 30 had evaluable course completion data.
Arm/Group Title Contingency Management Yoked Contingency Management
Hide Arm/Group Description:

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).

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).

Overall Number of Participants Analyzed 17 13
Measure Type: Number
Unit of Measure: participants
12 4
4.Secondary Outcome
Title Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)
Hide Description Abstinence will be measured using thrice weekly urine drug screens and self-report
Time Frame Thrice-weekly for 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
170 participants enrolled in the study, of which 30 were involved in a protocol violation that rendered their data un-analyzable. The final analytical sample is N = 140.
Arm/Group Title Contingency Management Yoked Contingency Management
Hide Arm/Group Description:

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).

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).

Overall Number of Participants Analyzed 70 70
Mean (Standard Deviation)
Unit of Measure: Stimulant-free urinalyses
8.9  (9.2) 6.0  (6.1)
Time Frame From enrollment to 6-month follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Contingency Management Yoked Contingency Management
Hide Arm/Group Description

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).

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).

All-Cause Mortality
Contingency Management Yoked Contingency Management
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Contingency Management Yoked Contingency Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/70 (1.43%)      1/70 (1.43%)    
General disorders     
Death * [1]  0/70 (0.00%)  0 1/70 (1.43%)  1
Psychiatric disorders     
Suicidal Ideation/Exacerbated Depression * [2]  1/70 (1.43%)  1 0/70 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Participant died of acute heroin overdose. Not study related.
[2]
Participant was hospitalized for suicidality. He was held in the emergency department overnight, and was subsequently transferred from the emergency room to another hospital for treatment of suicidal ideation.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Contingency Management Yoked Contingency Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/70 (11.43%)      0/70 (0.00%)    
Eye disorders     
Eye Swelling *  1/70 (1.43%)  1 0/70 (0.00%)  0
Gastrointestinal disorders     
Heartburn *  1/70 (1.43%)  1 0/70 (0.00%)  0
Diarrhea *  2/70 (2.86%)  2 0/70 (0.00%)  0
Rectal Bleeding *  1/70 (1.43%)  1 0/70 (0.00%)  0
Abdominal Pain *  1/70 (1.43%)  1 0/70 (0.00%)  0
General disorders     
Tooth Pain *  1/70 (1.43%)  1 0/70 (0.00%)  0
Insomnia *  1/70 (1.43%)  1 0/70 (0.00%)  0
Fatigue *  1/70 (1.43%)  1 0/70 (0.00%)  0
Hot Flashes *  1/70 (1.43%)  1 0/70 (0.00%)  0
Lightheadedness *  1/70 (1.43%)  1 0/70 (0.00%)  0
Skin and subcutaneous tissue disorders     
Ulcer on Hand * [1]  1/70 (1.43%)  1 0/70 (0.00%)  0
Throat Swelling *  1/70 (1.43%)  1 0/70 (0.00%)  0
Profuse Sweating *  1/70 (1.43%)  1 0/70 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Painless
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
Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01140880     History of Changes
Other Study ID Numbers: MC08-LA-710-FRI
First Submitted: June 8, 2010
First Posted: June 10, 2010
Results First Submitted: May 27, 2014
Results First Posted: July 2, 2014
Last Update Posted: April 7, 2015