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
  Purpose

The purpose of this study is to determine if persons randomized to receive adapted Personalized Cognitive Risk-reduction Counseling (PCC) will report greater reductions in unprotected anal sex behavior compared with persons who do not receive Personalized Cognitive Risk-reduction Counseling (PCC).


Condition Intervention Phase
HIV Infections
Episodic Substance Use
Behavioral: Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)
Behavioral: Standard HIV testing with information only
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM): Adaptation of the Personalized Cognitive Counseling (PCC) Intervention

Resource links provided by NLM:


Further study details as provided by San Francisco Department of Public Health:

Primary Outcome Measures:
  • Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner) [ Time Frame: Self-reported behavior during past 3 months ] [ Designated as safety issue: No ]
    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.

  • Total Unprotected Anal Intercourse Partners [ Time Frame: Self-reported behavior during past 3 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events [ Time Frame: Self-reported behavior during past 3 months ] [ Designated as safety issue: No ]

    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.


  • Number of Instertive UAI Events [ Time Frame: Self-reported behavior during past 3 months ] [ Designated as safety issue: No ]
    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.

  • Number of Receptive UAI Events [ Time Frame: Self-reported behavior during past 3 months ] [ Designated as safety issue: No ]
    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.

  • Number of Condom-protected Anal Intercourse Events [ Time Frame: Self-reported behavior during past 3 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 385
Study Start Date: September 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
HIV testing with adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)
Behavioral: 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.
Placebo Comparator: 2
HIV testing with information only
Behavioral: Standard HIV testing with information only
Standard HIV testing with information only

Detailed Description:

In the U.S., men who have sex with men (MSM) continue to constitute the greatest number of HIV/AIDS cases compared with other risk groups. Furthermore, many episodic substance using men who have sex with men (SUMSM) report that sex and substance use "always" or "often" go together. Studies have shown that substance use just before or during sex substantially increases HIV risk.

The formative phase of this research enrolled 59 HIV-negative episodic substance using MSM to participate in interviews to inform the adaptation of the Self-Justification Elicitation Instrument (SJEI) used during Personalized Cognitive Counseling (PCC) and to subsequently, pilot the adapted SJEI.

The randomized controlled trial (RCT) phase of this study enrolled 326 ethnically-diverse, HIV-negative episodic SUMSM to receive standard HIV rapid testing plus adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC) or standard HIV counseling and rapid testing only.

Specific Aims:

  1. To conduct formative research through individual interviews and pilot testing among a sample (n=59) of episodic substance-using men who have sex with men (SUMSM) to develop and adapt the key elements of the Personal Risk-Reduction Cognitive Counseling intervention, with a focus on eliciting and intervening on the thoughts, attitudes, and behaviors that episodic SUMSM employ when using substances and engaging in concurrent sexual risk.
  2. To determine the efficacy of the adapted intervention in reducing unprotected anal sex, as compared to routine HIV testing control condition, in a randomized trial of 326 episodic SUMSM.

We will also determine the efficacy of the intervention in reducing substance use.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Reports within the past 6 months unprotected anal intercourse (UAI) with another man while under the influence of at least one or any combination of the following substance: methamphetamine, poppers, crack or powder cocaine, or alcohol if binge drinking (5 or more drinks) within 2 hours before or during sex.
  2. Identifies as male.
  3. HIV-negative or unknown serostatus by self-report
  4. Willing and able to participate in an intervention that addresses episodic substance use and sexual risk behavior
  5. Not currently in substance use treatment, a self-help program, or an HIV prevention study
  6. Has not injected any substances in prior 6 months.
  7. ≥ 18 years old
  8. Planning to remain in the San Francisco Bay Area for the duration of study activities
  9. Willing and able to provide full informed consent. Able to speak, read, and understand English.

Exclusion Criteria:

  1. Reports within the past 6 months UAI with only one partner AND identifies that individual as a primary partner.
  2. In the prior three months, weekly or more use of any of the targeted substances (meth, poppers, crack or powder cocaine), with the exception of alcohol
  3. For alcohol, more than an average of 3 alcoholic drinks daily, or binge drinking more than twice weekly.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279044

Locations
United States, California
San Francisco Department of Public Health, AIDS Office
San Francisco, California, United States, 94102
Sponsors and Collaborators
San Francisco Department of Public Health
Investigators
Principal Investigator: Phillip O Coffin, MD, MIA Director of Substance Use Research, HIV Prevention, San Francisco Department of Public Health
Study Director: Jeffrey H Herbst, PhD Centers for Disease Control and Prevention
  More Information

Publications:
Responsible Party: Phillip Coffin, MD, MIA, Director of Substance Use Research, HIV Prevention, 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

Keywords provided by San Francisco Department of Public Health:
HIV
MSM
SUMSM

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
HIV Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014