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Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men

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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:
University of California, Los Angeles
Information provided by (Responsible Party):
Friends Research Institute, Inc.

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
Enrollment 53
Recruitment Details 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 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.
Arm/Group Title PEP/CM
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 53
Completed 51
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title PEP/CM
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
<=18 years
0
   0.0%
Between 18 and 65 years
53
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants
36.1  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
0
   0.0%
Male
53
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants
53
1.Primary Outcome
Title Self-reported Methamphetamine Use in Previous 30 Days.
Hide Description Mean number of days (of the past 30) of methamphetamine use.
Time Frame 3-months after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
53 enrolled and 2 were withdrawn.
Arm/Group Title PEP/CM
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: days
1.6  (2.4)
2.Secondary Outcome
Title Description of Incident STI Infections.
Hide Description Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.
Time Frame Baseline and 3-months
Hide Outcome Measure Data
Hide Analysis Population Description
53 enrolled and 2 were withdrawn.
Arm/Group Title PEP/CM
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Full Range)
Unit of Measure: Proportion of Participants
.074
(.045 to .114)
3.Secondary Outcome
Title HIV-related Sexual Risk Behaviors in Previous 30 Days.
Hide Description Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.
Time Frame 3-months after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
53 enrolled and 2 were withdrawn.
Arm/Group Title PEP/CM
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: episodes
.44  (1.4)
4.Secondary Outcome
Title Post-Exposure Prophylaxis Medication Adherence
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
35 participants initiated PEP
Arm/Group Title PEP/CM
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 35
Median (Inter-Quartile Range)
Unit of Measure: proportional medication adherence
0.96
(0.57 to 1.0)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PEP/CM
Hide Arm/Group Description

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.

All-Cause Mortality
PEP/CM
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
PEP/CM
Affected / at Risk (%) # Events
Total   2/53 (3.77%)    
Psychiatric disorders   
depression *  1/53 (1.89%)  1
Respiratory, thoracic and mediastinal disorders   
shortness of breath *  1/53 (1.89%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PEP/CM
Affected / at Risk (%) # Events
Total   4/53 (7.55%)    
Gastrointestinal disorders   
abdominal pain *  2/53 (3.77%)  2
diarrhea *  1/53 (1.89%)  1
flatulence *  1/53 (1.89%)  1
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Cathy Reback
Organization: Friends Research Institute, Inc.
Phone: 323-463-1601
EMail: reback@friendsresearch.org
Layout table for additonal information
Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00856323    
Other Study ID Numbers: 702632
First Submitted: March 3, 2009
First Posted: March 5, 2009
Results First Submitted: August 27, 2012
Results First Posted: November 27, 2012
Last Update Posted: September 20, 2016