Trial Outcomes & Findings for Biobehavioral Interventions for HIV-negative, Stimulant Using Men Who Have Sex With Men (NCT NCT01140880)
NCT ID: NCT01140880
Last Updated: 2025-03-17
Results Overview
Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
6-month follow-up
Results posted on
2025-03-17
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
100
|
|
Overall Study
COMPLETED
|
56
|
56
|
|
Overall Study
NOT COMPLETED
|
14
|
44
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
8
|
10
|
|
Overall Study
Protocol Violation
|
0
|
30
|
Baseline Characteristics
Biobehavioral Interventions for HIV-negative, Stimulant Using Men Who Have Sex With Men
Baseline characteristics by cohort
| Measure |
Contingency Management
n=70 Participants
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
n=70 Participants
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
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
37.9 years
STANDARD_DEVIATION 11.8 • n=107 Participants
|
36.8 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian/white
|
27 participants
n=99 Participants
|
25 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American/black
|
27 participants
n=99 Participants
|
25 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
11 participants
n=99 Participants
|
14 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiracial/Other
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=99 Participants
|
70 participants
n=107 Participants
|
140 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6-month follow-upPopulation: 40 participants with evaluable data initiated Truvada during the course of the study.
Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.
Outcome measures
| Measure |
Contingency Management
n=26 Participants
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
n=14 Participants
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).
|
|---|---|---|
|
Time From Exposure to Truvada Initiation
|
32.8 hours
Standard Deviation 15.1
|
33.0 hours
Standard Deviation 16.1
|
PRIMARY outcome
Timeframe: Daily throughout medication coursePopulation: 40 participants initiated Truvada, of which 30 had evaluable medication adherence and course completion data (the 10 others were involved in the protocol violation).
Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.
Outcome measures
| Measure |
Contingency Management
n=17 Participants
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
n=13 Participants
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).
|
|---|---|---|
|
Medication Adherence
|
0.75 proportion
NA
|
0.45 proportion
NA
|
PRIMARY outcome
Timeframe: 28-days post initiationPopulation: 40 participants initiated PEP during the study, of which 30 had evaluable course completion data.
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.
Outcome measures
| Measure |
Contingency Management
n=17 Participants
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
n=13 Participants
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).
|
|---|---|---|
|
Course Completion
|
12 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Thrice-weekly for 8 weeksPopulation: 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.
Abstinence will be measured using thrice weekly urine drug screens and self-report
Outcome measures
| Measure |
Contingency Management
n=70 Participants
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
n=70 Participants
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).
|
|---|---|---|
|
Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)
|
8.9 Stimulant-free urinalyses
Standard Deviation 9.2
|
6.0 Stimulant-free urinalyses
Standard Deviation 6.1
|
Adverse Events
Contingency Management
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Yoked Contingency Management
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Contingency Management
n=70 participants at risk
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
n=70 participants at risk
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).
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation/Exacerbated Depression
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
General disorders
Death
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
Other adverse events
| Measure |
Contingency Management
n=70 participants at risk
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
n=70 participants at risk
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).
|
|---|---|---|
|
Gastrointestinal disorders
Heartburn
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
Skin and subcutaneous tissue disorders
Ulcer on Hand
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
2/70 • Number of events 2 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
General disorders
Tooth Pain
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
Gastrointestinal disorders
Rectal Bleeding
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
Eye disorders
Eye Swelling
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
Skin and subcutaneous tissue disorders
Throat Swelling
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
General disorders
Insomnia
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
General disorders
Fatigue
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
General disorders
Hot Flashes
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
Skin and subcutaneous tissue disorders
Profuse Sweating
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
|
General disorders
Lightheadedness
|
1.4%
1/70 • Number of events 1 • From enrollment to 6-month follow-up.
|
0.00%
0/70 • From enrollment to 6-month follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place