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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier:
NCT01279044
First received: January 18, 2011
Last updated: September 30, 2014
Last verified: September 2014
Results First Received: March 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow for 2 periods

Period 1:   PHASE 1 - Formative
    Formative Phase 1     HIV Testing With Adapted Personalized Cognitive Risk-reduction     HIV Testing With Information Only  
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 2:   PHASE 2 - Randmonized Controlled Trial
    Formative Phase 1     HIV Testing With Adapted Personalized Cognitive Risk-reduction     HIV Testing With Information Only  
STARTED     0 [1]   162     164  
COMPLETED     0 [1]   151     161  
NOT COMPLETED     0     11     3  
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Phase 1 - Formative Research 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 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
Total Total of all reporting groups

Baseline Measures
    Phase 1 - Formative Research     HIV Testing With Adapted Personalized Cognitive Risk-reduction     HIV Testing With Information Only     Total  
Number of Participants  
[units: participants]
  59     162     164     385  
Age  
[units: years]
Mean ( Full Range )
  33  
  ( 18 to 50 )  
  34  
  ( 18 to 61 )  
  33.1  
  ( 19 to 63 )  
  33.6  
  ( 18 to 63 )  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     59     162     164     385  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     18     34     45     97  
Not Hispanic or Latino     41     128     119     288  
Unknown or Not Reported     0     0     0     0  
Race/Ethnicity, Customized  
[units: 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  
[units: participants]
       
United States     59     162     164     385  



  Outcome Measures
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1.  Primary:   Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)   [ Time Frame: Self-reported behavior during past 3 months ]

2.  Primary:   Total Unprotected Anal Intercourse Partners   [ Time Frame: Self-reported behavior during past 3 months ]

3.  Primary:   Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.   [ Time Frame: Self-reported behavior during past 3 months ]

4.  Secondary:   Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events   [ Time Frame: Self-reported behavior during past 3 months ]

5.  Secondary:   Number of Instertive UAI Events   [ Time Frame: Self-reported behavior during past 3 months ]

6.  Secondary:   Number of Receptive UAI Events   [ Time Frame: Self-reported behavior during past 3 months ]

7.  Secondary:   Number of Condom-protected Anal Intercourse Events   [ Time Frame: Self-reported behavior during past 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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


  More Information
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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
e-mail: phillip.coffin@sfdph.org


Publications of Results:
Other Publications:

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
Study First Received: January 18, 2011
Results First Received: March 18, 2014
Last Updated: September 30, 2014
Health Authority: United States: Federal Government