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

Primary Purpose

Social Anxiety, Substance Use

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Reduction of social anxiety & substance use in gay/bi men
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Social Anxiety focused on measuring social anxiety in sexual situations

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ryerson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive behavioural therapy

Arm Description

Reduction of social anxiety & substance use in gay/bi men

Outcomes

Primary Outcome Measures

Instances of unprotected anal intercourse with sexual partners who are HIV-positive or of unknown HIV status
Sexual Behavior and Related Measures: Sexual Risk Behavior and Related Assessment (self-report)

Secondary Outcome Measures

Severity of social anxiety and instances substance use in sexual situations
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)

Full Information

First Posted
May 24, 2013
Last Updated
March 9, 2020
Sponsor
Toronto Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT02045225
Brief Title
HIV Prevention for HIV-Negative Men Via Reduction of Social Anxiety
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety, Substance Use
Keywords
social anxiety in sexual situations

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioural therapy
Arm Type
Experimental
Arm Description
Reduction of social anxiety & substance use in gay/bi men
Intervention Type
Behavioral
Intervention Name(s)
Reduction of social anxiety & substance use in gay/bi men
Intervention Description
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.
Primary Outcome Measure Information:
Title
Instances of unprotected anal intercourse with sexual partners who are HIV-positive or of unknown HIV status
Description
Sexual Behavior and Related Measures: Sexual Risk Behavior and Related Assessment (self-report)
Time Frame
3, 6, and 9 months following baseline assessment
Secondary Outcome Measure Information:
Title
Severity of social anxiety and instances substance use in sexual situations
Description
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)
Time Frame
3, 6, and 9 months after baseline assessment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor A Hart, PhD
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ryerson University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1G8
Country
Canada

12. IPD Sharing Statement

Citations:
Citation
Remis RS, Swantee C, Schiedel L, Liu J. Report on HIV/AIDS in Ontario. March, 2008. http://www.health.gov.on.ca/english/providers/pub/aids/reports/report_hivaids_ontario_2006.pdf.
Results Reference
background
Citation
Public Health Agency of Canada. (2010). HIV and AIDS in Canada: Surveillance report to December 31, 2009. http://www.phac-aspc.gc.ca/aids-sida/publication/index-eng.php#surveillance.
Results Reference
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PubMed Identifier
16205961
Citation
Hart TA, Heimberg RG. Social anxiety as a risk factor for unprotected intercourse among gay and bisexual male youth. AIDS Behav. 2005 Dec;9(4):505-12. doi: 10.1007/s10461-005-9021-2.
Results Reference
background
PubMed Identifier
19025482
Citation
Hart TA, James CA, Purcell DW, Farber E. Social anxiety and HIV transmission risk among HIV-seropositive male patients. AIDS Patient Care STDS. 2008 Nov;22(11):879-86. doi: 10.1089/apc.2008.0085.
Results Reference
background
PubMed Identifier
18363421
Citation
Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008 Apr;69(4):621-32. doi: 10.4088/jcp.v69n0415.
Results Reference
background
PubMed Identifier
21293993
Citation
Semple SJ, Strathdee SA, Zians J, McQuaid J, Patterson TL. Psychosocial and behavioral correlates of anxiety symptoms in a sample of HIV-positive, methamphetamine-using men who have sex with men. AIDS Care. 2011 May;23(5):628-37. doi: 10.1080/09540121.2010.525608.
Results Reference
background
PubMed Identifier
20229264
Citation
Elkington KS, Bauermeister JA, Zimmerman MA. Psychological distress, substance use, and HIV/STI risk behaviors among youth. J Youth Adolesc. 2010 May;39(5):514-27. doi: 10.1007/s10964-010-9524-7. Epub 2010 Mar 14.
Results Reference
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HIV Prevention for HIV-Negative Men Via Reduction of Social Anxiety

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