HIV Prevention for HIV-Negative Men Via Reduction of Social Anxiety
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ClinicalTrials.gov Identifier: NCT02045225 |
Recruitment Status
:
Completed
First Posted
: January 24, 2014
Last Update Posted
: July 11, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Social Anxiety Substance Use | Behavioral: Reduction of social anxiety & substance use in gay/bi men | Phase 1 |
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 (Clinical Trial) |
Actual Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | June 2017 |
Actual Study Completion Date : | June 2017 |
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.
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- 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:
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)
- 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) 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)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045225
Canada, Ontario | |
Ryerson University | |
Toronto, Ontario, Canada, M5B1G8 |
Principal Investigator: | Trevor A Hart, PhD | Ryerson University |
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 ( Other Identifier: CIHR ) |
First Posted: | January 24, 2014 Key Record Dates |
Last Update Posted: | July 11, 2017 |
Last Verified: | July 2017 |
Keywords provided by Trevor Hart, Ryerson University:
social anxiety in sexual situations |
Additional relevant MeSH terms:
Anxiety Disorders Mental Disorders |