HIV Prevention for HIV-Negative Men Via Reduction of Social Anxiety
Condition: Social Anxiety; Substance Use
MeSH terms: Substance-Related Disorders; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Reduction of social anxiety & substance use in gay/bi men
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: social anxiety in sexual situations