Trial Outcomes & Findings for Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men (NCT NCT00856323)
NCT ID: NCT00856323
Last Updated: 2016-09-20
Results Overview
Mean number of days (of the past 30) of methamphetamine use.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
3-months after baseline
Results posted on
2016-09-20
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men
Baseline characteristics by cohort
| Measure |
PEP/CM
n=53 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3-months after baselinePopulation: 53 enrolled and 2 were withdrawn.
Mean number of days (of the past 30) of methamphetamine use.
Outcome measures
| Measure |
PEP/CM
n=51 Participants
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.
|
|---|---|
|
Self-reported Methamphetamine Use in Previous 30 Days.
|
1.6 days
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline and 3-monthsPopulation: 53 enrolled and 2 were withdrawn.
Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.
Outcome measures
| Measure |
PEP/CM
n=51 Participants
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.
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|---|---|
|
Description of Incident STI Infections.
|
.074 Proportion of Participants
Interval 0.045 to 0.114
|
SECONDARY outcome
Timeframe: 3-months after baselinePopulation: 53 enrolled and 2 were withdrawn.
Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.
Outcome measures
| Measure |
PEP/CM
n=51 Participants
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.
|
|---|---|
|
HIV-related Sexual Risk Behaviors in Previous 30 Days.
|
.44 episodes
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 28-daysPopulation: 35 participants initiated PEP
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).
Outcome measures
| Measure |
PEP/CM
n=35 Participants
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.
|
|---|---|
|
Post-Exposure Prophylaxis Medication Adherence
|
0.96 proportional medication adherence
Interval 0.57 to 1.0
|
Adverse Events
PEP/CM
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEP/CM
n=53 participants at risk
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.
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|---|---|
|
Psychiatric disorders
depression
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
1.9%
1/53 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
PEP/CM
n=53 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
3.8%
2/53 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
diarrhea
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
flatulence
|
1.9%
1/53 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place