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

Primary Purpose

HIV Infections, Episodic Substance Use

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)
Standard HIV testing with information only
Sponsored by
San Francisco Department of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, MSM, SUMSM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • San Francisco Department of Public Health, AIDS Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

HIV testing with adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)

HIV testing with information only

Outcomes

Primary Outcome Measures

Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)
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
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.
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
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
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
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
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.

Full Information

First Posted
January 18, 2011
Last Updated
September 30, 2014
Sponsor
San Francisco Department of Public Health
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01279044
Brief Title
Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM)
Official Title
Reducing HIV Risk Among Episodic Substance Using Men Who Have Sex With Men (SUMSM): Adaptation of the Personalized Cognitive Counseling (PCC) Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Francisco Department of Public Health
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Episodic Substance Use
Keywords
HIV, MSM, SUMSM

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
HIV testing with adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
HIV testing with information only
Intervention Type
Behavioral
Intervention Name(s)
Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard HIV testing with information only
Intervention Description
Standard HIV testing with information only
Primary Outcome Measure Information:
Title
Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)
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
Title
Total Unprotected Anal Intercourse Partners
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
Title
Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.
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
Secondary Outcome Measure Information:
Title
Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events
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
Title
Number of Instertive UAI Events
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
Title
Number of Receptive UAI Events
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
Title
Number of Condom-protected Anal Intercourse Events
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Identifies as male. HIV-negative or unknown serostatus by self-report Willing and able to participate in an intervention that addresses episodic substance use and sexual risk behavior Not currently in substance use treatment, a self-help program, or an HIV prevention study Has not injected any substances in prior 6 months. ≥ 18 years old Planning to remain in the San Francisco Bay Area for the duration of study activities Willing and able to provide full informed consent. Able to speak, read, and understand English. Exclusion Criteria: Reports within the past 6 months UAI with only one partner AND identifies that individual as a primary partner. 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 For alcohol, more than an average of 3 alcoholic drinks daily, or binge drinking more than twice weekly.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip O Coffin, MD, MIA
Organizational Affiliation
Director of Substance Use Research, HIV Prevention, San Francisco Department of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey H Herbst, PhD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Study Director
Facility Information:
Facility Name
San Francisco Department of Public Health, AIDS Office
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23572012
Citation
Santos GM, Coffin PO, Das M, Matheson T, DeMicco E, Raiford JL, Vittinghoff E, Dilley JW, Colfax G, Herbst JH. Dose-response associations between number and frequency of substance use and high-risk sexual behaviors among HIV-negative substance-using men who have sex with men (SUMSM) in San Francisco. J Acquir Immune Defic Syndr. 2013 Aug 1;63(4):540-4. doi: 10.1097/QAI.0b013e318293f10b.
Results Reference
background
PubMed Identifier
23412947
Citation
Knight KR, Das M, DeMicco E, Raiford JL, Matheson T, Shook A, Antunez E, Santos GM, Dadasovich R, Dilley JW, Colfax GN, Herbst JH. A roadmap for adapting an evidence-based HIV prevention intervention: personal cognitive counseling (PCC) for episodic substance-using men who have sex with men. Prev Sci. 2014 Jun;15(3):364-75. doi: 10.1007/s11121-013-0364-z.
Results Reference
background
PubMed Identifier
24510401
Citation
Coffin PO, Santos GM, Colfax G, Das M, Matheson T, DeMicco E, Dilley J, Vittinghoff E, Raiford JL, Carry M, Herbst JH. Adapted personalized cognitive counseling for episodic substance-using men who have sex with men: a randomized controlled trial. AIDS Behav. 2014 Jul;18(7):1390-400. doi: 10.1007/s10461-014-0712-4.
Results Reference
result

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

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