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

March 9, 2020 updated by: Trevor Hart, Ryerson University

An HIV Prevention Intervention for HIV-negative Men Who Have Sex With Men Via Reduction of Social Anxiety and Substance Use in Sexual Situations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B1G8
        • Ryerson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Sexual Behavior and Related Measures:

Sexual Risk Behavior and Related Assessment (self-report)
3, 6, and 9 months following baseline assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of social anxiety and instances substance use in sexual situations
Time Frame: 3, 6, and 9 months after baseline assessment

Social Anxiety Measures:

Social Interaction Anxiety Scale (SIAS) Social Phobia Scale (SPS) Liebowitz Social Anxiety Scale (LSAS) Anxiety Disorders Interview Schedule (ADIS-DSM-IV) Brief Fear of Negative Evaluation Scale, Straightforward Items (BFNE-S)

Substance Use Measures:

The Alcohol Use Disorders Identification Test (AUDIT) Brief Michigan Alcohol Screening Test (BMAST) The Addictions Severity Index Lite (ASI-Lite)
3, 6, and 9 months after baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryerson University

Investigators

  • Principal Investigator: Trevor A Hart, PhD, Ryerson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201203HHP-279414-PB1ABAF146056
  • 201203HHP-279414 (Other Identifier: CIHR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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