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Trial record 7 of 42 for:    " January 12, 2011":" February 11, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM)

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ClinicalTrials.gov Identifier: NCT01279044
Recruitment Status : Completed
First Posted : January 19, 2011
Results First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions HIV Infections
Episodic Substance Use
Interventions Behavioral: Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)
Behavioral: Standard HIV testing with information only
Enrollment 385
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Formative Phase 1 HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Hide Arm/Group Description Individual interviews and pilot testing to develop and adapt key elements of Personal Cognitive Counseling 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. Standard HIV testing with information only: Standard HIV testing with information only
Period Title: PHASE 1 - Formative
Started 59 0 [1] 0 [1]
Completed 59 0 [1] 0 [1]
Not Completed 0 0 0
[1]
Participants who participated in the formative phase did not participate in the RCT.
Period Title: PHASE 2 - Randmonized Controlled Trial
Started 0 [1] 162 164
Completed 0 [1] 151 161
Not Completed 0 11 3
Reason Not Completed
Withdrawal by Subject             0             3             2
Lost to Follow-up             0             8             0
Death             0             0             1
[1]
Participants who participated in the RCT did not participate in the formative phase.
Arm/Group Title Phase 1 - Formative Research HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only Total
Hide Arm/Group Description Formative research through individual interviews and pilot testing to develop and adapt the key elements of Personal Cognitive Counseling 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. Standard HIV testing with information only: Standard HIV testing with information only Total of all reporting groups
Overall Number of Baseline Participants 59 162 164 385
Hide Baseline Analysis Population Description
There were no significant differences between the two study arms on baseline demographics, HIV testing, and substance use. The mean age was 33.6 years; 49% were white and 51% non-white including 26% Latino/Hispanic, 11% Asian and Pacific Islander, 10% black/African American, and 6% mixed/other race.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 59 participants 162 participants 164 participants 385 participants
33
(18 to 50)
34
(18 to 61)
33.1
(19 to 63)
33.6
(18 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 162 participants 164 participants 385 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
59
 100.0%
162
 100.0%
164
 100.0%
385
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 162 participants 164 participants 385 participants
Hispanic or Latino
18
  30.5%
34
  21.0%
45
  27.4%
97
  25.2%
Not Hispanic or Latino
41
  69.5%
128
  79.0%
119
  72.6%
288
  74.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 162 participants 164 participants 385 participants
Black/African American 3 17 16 36
Asian Pacific Islander 6 14 22 42
Mixed 3 12 12 27
Native American 1 1 1 3
Other 0 34 39 73
White 46 84 74 204
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants 162 participants 164 participants 385 participants
59 162 164 385
1.Primary Outcome
Title Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)
Hide Description 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.
Time Frame Self-reported behavior during past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Hide Arm/Group Description:
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.
Standard HIV testing with information only: Standard HIV testing with information only
Overall Number of Participants Analyzed 162 164
Measure Type: Number
Unit of Measure: Self reported events in past 3 months
Mean number at baseline 4.23 3.91
Mean number at 3 months 3.41 2.05
Mean number at 6 months 1.83 1.96
Rate of change in mean value of outcome over time 0.47 0.45
2.Primary Outcome
Title Total Unprotected Anal Intercourse Partners
Hide Description The 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.
Time Frame Self-reported behavior during past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Hide Arm/Group Description:
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.
Standard HIV testing with information only: Standard HIV testing with information only
Overall Number of Participants Analyzed 162 164
Measure Type: Number
Unit of Measure: Partners in past 3 months
Mean number of partners at baseline 2.71 2.60
Mean number of partners at 3 months 1.54 1.37
Mean number of partners at 6 months 1.27 1.16
Rate of change in mean value of outcome over time 0.46 0.43
3.Primary Outcome
Title Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.
Hide Description The 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.
Time Frame Self-reported behavior during past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Hide Arm/Group Description:
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.
Standard HIV testing with information only: Standard HIV testing with information only
Overall Number of Participants Analyzed 162 164
Measure Type: Number
Unit of Measure: Episodes in past 3 months
Mean number of episodes at baseline 1.97 2.31
Mean number of episodes at 3 months 1.12 1.11
Mean number of episodes at 6 months 0.83 1.20
Rate of change in mean value of outcome over time 0.39 0.52
4.Secondary Outcome
Title Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events
Hide Description

The 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.

Time Frame Self-reported behavior during past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Hide Arm/Group Description:
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.
Standard HIV testing with information only: Standard HIV testing with information only
Overall Number of Participants Analyzed 162 164
Measure Type: Number
Unit of Measure: Events in past 3 months
Mean number of events at baseline 1.06 1.13
Mean number of events at 3 months 0.43 0.49
Mean number of events at 6 months 0.34 0.55
Rate of change in mean value of outcome over time 0.28 0.47
5.Secondary Outcome
Title Number of Instertive UAI Events
Hide Description The 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.
Time Frame Self-reported behavior during past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Hide Arm/Group Description:
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.
Standard HIV testing with information only: Standard HIV testing with information only
Overall Number of Participants Analyzed 162 164
Measure Type: Number
Unit of Measure: Self reported behavior in past 3 months
Mean number of events at baseline 2.84 2.44
Mean number of events at 3 months 2.80 1.32
Mean number of events at 6 months 1.37 1.14
Rate of change in mean value over time 0.55 0.41
6.Secondary Outcome
Title Number of Receptive UAI Events
Hide Description The 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.
Time Frame Self-reported behavior during past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Hide Arm/Group Description:
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.
Standard HIV testing with information only: Standard HIV testing with information only
Overall Number of Participants Analyzed 162 164
Measure Type: Number
Unit of Measure: Self reported behavior in past 3 months
Mean number of events at baseline 1.39 1.48
Mean number of events at 3 months 0.61 0.73
Mean number of events at 6 months 0.45 0.82
Rate of change in mean value of outcome over time 0.31 0.53
7.Secondary Outcome
Title Number of Condom-protected Anal Intercourse Events
Hide Description

The 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.

Time Frame Self-reported behavior during past 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Hide Arm/Group Description:
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.
Standard HIV testing with information only: Standard HIV testing with information only
Overall Number of Participants Analyzed 162 164
Measure Type: Number
Unit of Measure: Self reported behavior in past 3 months
Mean number of events at baseline 3.78 2.83
Mean number of events at 3 months 1.67 2.13
Mean number of events at 6 months 2.11 1.29
Rate of change in mean value of outcome over time 0.57 0.44
Time Frame Two years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Hide Arm/Group Description 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. Standard HIV testing with information only: Standard HIV testing with information only
All-Cause Mortality
HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/162 (0.00%)      1/164 (0.61%)    
Psychiatric disorders     
Death  [1]  0/162 (0.00%)  1/164 (0.61%)  1
Indicates events were collected by systematic assessment
[1]
Suicide
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV Testing With Adapted Personalized Cognitive Risk-reduction HIV Testing With Information Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/162 (0.00%)      0/164 (0.00%)    
Self-report data subject to recall bias Sample is San Francisco SUMSM; may not be generalizable to other locations 42% screened as substance-dependent per SDS Inclusion of dependent MSM reduced ability to detect significant intervention effects
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. Phillip Coffin, Director of Substance Abuse Research Unit
Organization: San Francisco Department of Public Health
Phone: (415) 437 6282
Responsible Party: Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT01279044     History of Changes
Other Study ID Numbers: 1UR6PS000684-01 ( U.S. NIH Grant/Contract )
First Submitted: January 18, 2011
First Posted: January 19, 2011
Results First Submitted: March 18, 2014
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014