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

T

Toronto Metropolitan University

Status and phase

Completed
Phase 1

Conditions

Social Anxiety
Substance Use

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02045225
201203HHP-279414-PB1ABAF146056
201203HHP-279414 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Cognitive behavioural therapy
Experimental group
Description:
Reduction of social anxiety & substance use in gay/bi men
Treatment:
Behavioral: Reduction of social anxiety & substance use in gay/bi men

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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