Trial Outcomes & Findings for Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM) (NCT NCT01279044)
NCT ID: NCT01279044
Last Updated: 2014-10-07
Results Overview
The outcome measure data shows the rate of change in the mean value in the number of total unprotected anal intercourse events over time. Behaviors were self-reported at each study visit using "during the past 3 months" as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
385 participants
Primary outcome timeframe
Self-reported behavior during past 3 months
Results posted on
2014-10-07
Participant Flow
Recruitment involved outreach at community venues in San Francisco, including bars, clubs, grocery stores, gyms, and other venues frequented by MSM. To recruit a racially and ethnically diverse sample of episodic SUMSM, recruitment also occurred at community-based organizations serving African American, Latino, and Asian and Pacific Islander MSM.
Potential participants completed brief telephone screening to assess initial eligibility and, if eligible, were scheduled for in-person re-screening visits. If potential participants were ineligible at the re-screening visit, they were thanked for their time and did not continue with study activities, such as randomization in the RCT.
Participant milestones
| Measure |
Formative Phase 1
Individual interviews and pilot testing to develop and adapt key elements of Personal Cognitive Counseling
|
HIV Testing With Adapted Personalized Cognitive Risk-reduction
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
|
HIV Testing With Information Only
Standard HIV testing with information only: Standard HIV testing with information only
|
|---|---|---|---|
|
PHASE 1 - Formative
STARTED
|
59
|
0
|
0
|
|
PHASE 1 - Formative
COMPLETED
|
59
|
0
|
0
|
|
PHASE 1 - Formative
NOT COMPLETED
|
0
|
0
|
0
|
|
PHASE 2 - Randmonized Controlled Trial
STARTED
|
0
|
162
|
164
|
|
PHASE 2 - Randmonized Controlled Trial
COMPLETED
|
0
|
151
|
161
|
|
PHASE 2 - Randmonized Controlled Trial
NOT COMPLETED
|
0
|
11
|
3
|
Reasons for withdrawal
| Measure |
Formative Phase 1
Individual interviews and pilot testing to develop and adapt key elements of Personal Cognitive Counseling
|
HIV Testing With Adapted Personalized Cognitive Risk-reduction
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
|
HIV Testing With Information Only
Standard HIV testing with information only: Standard HIV testing with information only
|
|---|---|---|---|
|
PHASE 2 - Randmonized Controlled Trial
Withdrawal by Subject
|
0
|
3
|
2
|
|
PHASE 2 - Randmonized Controlled Trial
Lost to Follow-up
|
0
|
8
|
0
|
|
PHASE 2 - Randmonized Controlled Trial
Death
|
0
|
0
|
1
|
Baseline Characteristics
Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM)
Baseline characteristics by cohort
| Measure |
Phase 1 - Formative Research
n=59 Participants
Formative research through individual interviews and pilot testing to develop and adapt the key elements of Personal Cognitive Counseling
|
HIV Testing With Adapted Personalized Cognitive Risk-reduction
n=162 Participants
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
|
HIV Testing With Information Only
n=164 Participants
Standard HIV testing with information only: Standard HIV testing with information only
|
Total
n=385 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33 years
n=5 Participants
|
34 years
n=7 Participants
|
33.1 years
n=5 Participants
|
33.6 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
385 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
288 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 participants
n=5 Participants
|
17 participants
n=7 Participants
|
16 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian Pacific Islander
|
6 participants
n=5 Participants
|
14 participants
n=7 Participants
|
22 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
3 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
34 participants
n=7 Participants
|
39 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
46 participants
n=5 Participants
|
84 participants
n=7 Participants
|
74 participants
n=5 Participants
|
204 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
162 participants
n=7 Participants
|
164 participants
n=5 Participants
|
385 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Self-reported behavior during past 3 monthsThe outcome measure data shows the rate of change in the mean value in the number of total unprotected anal intercourse events over time. Behaviors were self-reported at each study visit using "during the past 3 months" as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.
Outcome measures
| Measure |
HIV Testing With Adapted Personalized Cognitive Risk-reduction
n=162 Participants
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
|
HIV Testing With Information Only
n=164 Participants
Standard HIV testing with information only: Standard HIV testing with information only
|
|---|---|---|
|
Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)
Mean number at baseline
|
4.23 Self reported events in past 3 months
|
3.91 Self reported events in past 3 months
|
|
Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)
Mean number at 3 months
|
3.41 Self reported events in past 3 months
|
2.05 Self reported events in past 3 months
|
|
Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)
Mean number at 6 months
|
1.83 Self reported events in past 3 months
|
1.96 Self reported events in past 3 months
|
|
Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)
Rate of change in mean value of outcome over time
|
0.47 Self reported events in past 3 months
|
0.45 Self reported events in past 3 months
|
PRIMARY outcome
Timeframe: Self-reported behavior during past 3 monthsThe outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse partners over time. Behaviors were self-reported at each study visit using "during the past 3 months" as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.
Outcome measures
| Measure |
HIV Testing With Adapted Personalized Cognitive Risk-reduction
n=162 Participants
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
|
HIV Testing With Information Only
n=164 Participants
Standard HIV testing with information only: Standard HIV testing with information only
|
|---|---|---|
|
Total Unprotected Anal Intercourse Partners
Rate of change in mean value of outcome over time
|
0.46 Partners in past 3 months
|
0.43 Partners in past 3 months
|
|
Total Unprotected Anal Intercourse Partners
Mean number of partners at baseline
|
2.71 Partners in past 3 months
|
2.60 Partners in past 3 months
|
|
Total Unprotected Anal Intercourse Partners
Mean number of partners at 3 months
|
1.54 Partners in past 3 months
|
1.37 Partners in past 3 months
|
|
Total Unprotected Anal Intercourse Partners
Mean number of partners at 6 months
|
1.27 Partners in past 3 months
|
1.16 Partners in past 3 months
|
PRIMARY outcome
Timeframe: Self-reported behavior during past 3 monthsThe outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse episodes with three most recent sex partners over time. Behaviors were self-reported at each study visit using "during the past 3 months" as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.
Outcome measures
| Measure |
HIV Testing With Adapted Personalized Cognitive Risk-reduction
n=162 Participants
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
|
HIV Testing With Information Only
n=164 Participants
Standard HIV testing with information only: Standard HIV testing with information only
|
|---|---|---|
|
Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.
Mean number of episodes at baseline
|
1.97 Episodes in past 3 months
|
2.31 Episodes in past 3 months
|
|
Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.
Mean number of episodes at 3 months
|
1.12 Episodes in past 3 months
|
1.11 Episodes in past 3 months
|
|
Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.
Mean number of episodes at 6 months
|
0.83 Episodes in past 3 months
|
1.20 Episodes in past 3 months
|
|
Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.
Rate of change in mean value of outcome over time
|
0.39 Episodes in past 3 months
|
0.52 Episodes in past 3 months
|
SECONDARY outcome
Timeframe: Self-reported behavior during past 3 monthsThe outcome measure data shows the rate of change in the mean value of number of serodiscordant unprotected anal intercourse events. Behaviors were self-reported at each study visit using "during the past 3 months" as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints. Serodiscordant defined as having partner of discordant or of unknown HIV serostatus.
Outcome measures
| Measure |
HIV Testing With Adapted Personalized Cognitive Risk-reduction
n=162 Participants
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
|
HIV Testing With Information Only
n=164 Participants
Standard HIV testing with information only: Standard HIV testing with information only
|
|---|---|---|
|
Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events
Mean number of events at baseline
|
1.06 Events in past 3 months
|
1.13 Events in past 3 months
|
|
Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events
Mean number of events at 3 months
|
0.43 Events in past 3 months
|
0.49 Events in past 3 months
|
|
Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events
Mean number of events at 6 months
|
0.34 Events in past 3 months
|
0.55 Events in past 3 months
|
|
Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events
Rate of change in mean value of outcome over time
|
0.28 Events in past 3 months
|
0.47 Events in past 3 months
|
SECONDARY outcome
Timeframe: Self-reported behavior during past 3 monthsThe outcome measure data shows the rate of change in the mean value of number of instertive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using "during the past 3 months" as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.
Outcome measures
| Measure |
HIV Testing With Adapted Personalized Cognitive Risk-reduction
n=162 Participants
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
|
HIV Testing With Information Only
n=164 Participants
Standard HIV testing with information only: Standard HIV testing with information only
|
|---|---|---|
|
Number of Instertive UAI Events
Mean number of events at baseline
|
2.84 Self reported behavior in past 3 months
|
2.44 Self reported behavior in past 3 months
|
|
Number of Instertive UAI Events
Mean number of events at 3 months
|
2.80 Self reported behavior in past 3 months
|
1.32 Self reported behavior in past 3 months
|
|
Number of Instertive UAI Events
Mean number of events at 6 months
|
1.37 Self reported behavior in past 3 months
|
1.14 Self reported behavior in past 3 months
|
|
Number of Instertive UAI Events
Rate of change in mean value over time
|
0.55 Self reported behavior in past 3 months
|
0.41 Self reported behavior in past 3 months
|
SECONDARY outcome
Timeframe: Self-reported behavior during past 3 monthsThe outcome measure data shows the rate of change in the mean value of the number of receptive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using "during the past 3 months" as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.
Outcome measures
| Measure |
HIV Testing With Adapted Personalized Cognitive Risk-reduction
n=162 Participants
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
|
HIV Testing With Information Only
n=164 Participants
Standard HIV testing with information only: Standard HIV testing with information only
|
|---|---|---|
|
Number of Receptive UAI Events
Rate of change in mean value of outcome over time
|
0.31 Self reported behavior in past 3 months
|
0.53 Self reported behavior in past 3 months
|
|
Number of Receptive UAI Events
Mean number of events at baseline
|
1.39 Self reported behavior in past 3 months
|
1.48 Self reported behavior in past 3 months
|
|
Number of Receptive UAI Events
Mean number of events at 3 months
|
0.61 Self reported behavior in past 3 months
|
0.73 Self reported behavior in past 3 months
|
|
Number of Receptive UAI Events
Mean number of events at 6 months
|
0.45 Self reported behavior in past 3 months
|
0.82 Self reported behavior in past 3 months
|
SECONDARY outcome
Timeframe: Self-reported behavior during past 3 monthsThe outcome measure data shows the rate of change in the mean value of the number of condom-protected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using "during the past 3 months" as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints. Serodiscordant defined as having partner of discordant or of unknown HIV serostatus.
Outcome measures
| Measure |
HIV Testing With Adapted Personalized Cognitive Risk-reduction
n=162 Participants
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
|
HIV Testing With Information Only
n=164 Participants
Standard HIV testing with information only: Standard HIV testing with information only
|
|---|---|---|
|
Number of Condom-protected Anal Intercourse Events
Mean number of events at 3 months
|
1.67 Self reported behavior in past 3 months
|
2.13 Self reported behavior in past 3 months
|
|
Number of Condom-protected Anal Intercourse Events
Mean number of events at baseline
|
3.78 Self reported behavior in past 3 months
|
2.83 Self reported behavior in past 3 months
|
|
Number of Condom-protected Anal Intercourse Events
Mean number of events at 6 months
|
2.11 Self reported behavior in past 3 months
|
1.29 Self reported behavior in past 3 months
|
|
Number of Condom-protected Anal Intercourse Events
Rate of change in mean value of outcome over time
|
0.57 Self reported behavior in past 3 months
|
0.44 Self reported behavior in past 3 months
|
Adverse Events
HIV Testing With Adapted Personalized Cognitive Risk-reduction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Testing With Information Only
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV Testing With Adapted Personalized Cognitive Risk-reduction
n=162 participants at risk
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
|
HIV Testing With Information Only
n=164 participants at risk
Standard HIV testing with information only: Standard HIV testing with information only
|
|---|---|---|
|
Psychiatric disorders
Death
|
0.00%
0/162 • Two years
|
0.61%
1/164 • Number of events 1 • Two years
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Phillip Coffin, Director of Substance Abuse Research Unit
San Francisco Department of Public Health
Phone: (415) 437 6282
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place