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HIV Prevention for HIV-Negative Men Via Reduction of Social Anxiety

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Ryerson University
Sponsor:
Information provided by (Responsible Party):
Trevor Hart, Ryerson University
ClinicalTrials.gov Identifier:
NCT02045225
First received: May 24, 2013
Last updated: November 12, 2014
Last verified: November 2014
History of Changes
  Purpose

Men who have sex with men (MSM) bear a disproportionate burden of the Human Immunodeficiency Virus (HIV) epidemic in Canada, and HIV incidence appears to be rising among Canadian MSM (1). MSM comprised nearly half (44.1%) of new positive HIV tests in 2009 (2). Among MSM in Ontario, from 2001 to 2006, HIV diagnoses increased 26% (3). Given the alarmingly high HIV prevalence rates among MSM in North American cities, there is a critical need for HIV prevention interventions for MSM in Canada. Social anxiety, or anxiety about being evaluated in interpersonal situations, is a reliable risk factor for unprotected anal intercourse (UAI) among MSM (4 and 5). Social anxiety is highly modifiable via cognitive-behavioural therapy, a form of psychotherapy (6). Social anxiety may also increase substance use in sexual situations, which is another risk factor for HIV among MSM (7 and 8). As such, an empirically-based social anxiety treatment may also reduce HIV risk behaviours among MSM. The present study will provide Phase I trial data for a novel and innovative HIV prevention intervention for MSM. This is a proposal to test a novel integrated HIV prevention intervention that combines empirically supported treatments for social anxiety with HIV risk reduction counseling to reduce HIV sexual risk behaviour.


Condition Intervention Phase
Social Anxiety
Substance Use
 Behavioral: Reduction of social anxiety & substance use in gay/bi men
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An HIV Prevention Intervention for HIV-negative Men Who Have Sex With Men Via Reduction of Social Anxiety and Substance Use in Sexual Situations

Resource links provided by NLM:

MedlinePlus related topics: Anxiety HIV/AIDS
U.S. FDA Resources

Further study details as provided by Ryerson University:

Primary Outcome Measures:
  • Instances of unprotected anal intercourse with sexual partners who are HIV-positive or of unknown HIV status [ Time Frame: 3, 6, and 9 months following baseline assessment ] [ Designated as safety issue: No ]

    Sexual Behavior and Related Measures:

    The Sexual Risks Scale - Perceived Susceptibility (SRSP) Risk Reduction Strategy Use Condom Use Self-Efficacy and Intention to Use Condoms Sexual Risk Behavior and Related Assessment (self-report)



Secondary Outcome Measures:
  • Severity of social anxiety and instances substance use in sexual situations [ Time Frame: 3, 6, and 9 months after baseline assessment ] [ Designated as safety issue: No ]

    Social Anxiety Measures:

    Social Interaction Anxiety Scale (SIAS) Social Phobia Scale (SPS) Liebowitz Social Anxiety Scale (LSAS) Anxiety Disorders Interview Schedule (ADIS-DSM-IV) Social Anxiety Session Change Index (SASCI) Fear of Being Sexually Rejected

    Substance Use Measures:

    The Alcohol Use Disorders Identification Test (AUDIT) Brief Michigan Alcohol Screening Test (BMAST) The Addictions Severity Index Lite (ASI-Lite)
Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive behavioural therapy
Reduction of social anxiety & substance use in gay/bi men
 Behavioral: Reduction of social anxiety & substance use in gay/bi men
The study will provide Phase I trial data for a novel and innovative HIV prevention intervention for MSM built upon empirically supported interventions to reduce HIV risk among MSM and cognitive-behavioural therapy to reduce social anxiety. This study will test a novel integrated HIV prevention intervention that combines empirically supported treatments for social anxiety with HIV risk reduction counseling to reduce HIV sexual risk behaviour. Study objectives: 1) to provide data on the acceptability/feasibility of the intervention, 2) to provide data to test the intervention, and 3) to provide data that will allow for a RCT that will test intervention efficacy relative to HIV prevention interventions that do not reduce social anxiety or substance use in sexual situations.

Detailed Description:

The present study will provide pilot data for a novel and innovative HIV prevention intervention for MSM. This intervention will build upon empirically supported interventions to reduce HIV risk among MSM and cognitive-behavioural therapy to reduce social anxiety. This pilot study will serve 3 related major objectives: 1) to provide data on the acceptability and feasibility of the intervention administered, 2) to provide pilot data testing the intervention, and 3) to provide data that will allow Dr. Hart and his team to apply to CIHR for a Phase II trial that will test the efficacy of the intervention relative to HIV prevention interventions that do not reduce social anxiety or substance use in sexual situations among MSM.

Participants attend 4 assessment sessions, during which they complete a series of interviews and questionnaires regarding social anxiety, substance use, and sexual risk behaviours. Participants also attend 10 sessions of counselling, where a therapist seeks to help the participant work towards reducing his anxiety in social and sexual situations and try to better manage his use of alcohol and drugs in sexual situations. The participant undergoes a baseline assessment, followed by 10 weekly counselling sessions, a post-treatment assessment, and 3- and 6-month follow-up assessments.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 18-65 years
  • male identified
  • gay or bisexual identified
  • experiencing social anxiety in sexual situations
  • condomless anal sex with a casual (or non-monogamous) HIV-positive or unknown serostatus partner in the last 3 months
  • consumption of alcohol and/or a recreational drug within 2 hours before sex or during sex within the last 3 months

Exclusion Criteria:

  • younger than 18 or older than 65 years of age
  • not male identified
  • sexual orientation other than gay or bisexual
  • no experiences of social anxiety in sexual situations
  • severe mental illness
  • already receiving psychotherapy
  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: NCT02045225

Locations
Canada, Ontario
Ryerson University Recruiting
Toronto, Ontario, Canada, M5B1G8
Contact: Trevor A. Hart, PhD    416.979.5000 ext 6192    trevor.hart@ryerson.ca   
Principal Investigator: Trevor A Hart, PhD         
Sponsors and Collaborators
Ryerson University
Investigators
Principal Investigator: Trevor A Hart, PhD Ryerson University
  More Information

Publications:

Responsible Party: Trevor Hart, Principal Investigator, Ryerson University
ClinicalTrials.gov Identifier: NCT02045225     History of Changes
Other Study ID Numbers: 201203HHP-279414-PB1ABAF146056, 201203HHP-279414
Study First Received: May 24, 2013
Last Updated: November 12, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Ryerson University:
social anxiety in sexual situations

ClinicalTrials.gov processed this record on March 03, 2015