About The Study

This study will evaluate an HIV prevention intervention for HIV-negative gay and bisexual men who experience problems with social anxiety. The study combines empirically supported treatments for social anxiety with HIV risk reduction counselling to reduce HIV sexual risk behaviour. The three primary study objectives are: 1) to provide data on the acceptability and feasibility of the intervention, 2) to provide data to test the intervention, and 3) to provide data to support a future randomized controlled trial that will test the efficacy of the intervention relative to HIV prevention interventions that do not look to reducing social anxiety or substance use in sexual situations. Researchers aim to develop a larger randomized study with an overall goal to develop an effective form of counselling that promotes confidence in social and sexual situations and that will help prevent HIV transmission and reduce sexual risk behaviours.

About The Disease

Social anxiety is commonly defined as the experience of fear and apprehension about being evaluated in interpersonal situations. Evidence indicates that gay, bisexual and other MSM may be at particular risk for social anxiety because of an adverse social environment during development. Social anxiety is according to the researchers a reliable risk factor for unprotected anal intercourse (UAI) among MSM. Social anxiety may also increase substance use in sexual situations, which is another risk factor for HIV among MSM. As such the researchers seek to show that an empirically-based social anxiety treatment may also reduce HIV risk behaviours among MSM.

Study Approach

The counseling intervention broadly targets both cognitive and behavioural reactions to social anxiety and its effects on substance use. Cognitive Behavioural Therapy was chosen as the intervention counseling method because of the evidence supporting its use for social anxiety, and for treatments that combine mood/anxiety disorder treatment with substance use treatments. The Investigators seek to recruit 20 HIV-negative MSM participants. After a baseline assessment, participants will go through 10 weekly behavioural counselling sessions and will be followed up with a post-intervention assessment and questionnaires for six months. Assessments will include interviews and self-report measures of social anxiety, substance use in sexual situations, and sexual risk behaviours.

If you would like more information on this clinical study, please refer to Dr. Hart’s website or to the trial listing on clinicaltrials.gov.

Eligibility Requirements

Required

  • HIV-negative men 18-65 years of age who have had Unprotected Anal Intercourse (UAI) with at least one male sexual partner who was HIV-positive or of unknown status in the past 3 months
  • Participants must report at least some social anxiety on the screening item for social anxiety. Participants do not need to have clinically significant social anxiety to be included
  • Lastly, participants must report alcohol or other substance use within 2 hours or during sexual activity at least once in the past 3 months

Not Allowed

  • Persons will be excluded if it is found that their ability to respond to study measures is compromised by mental or physical disabilities or inability to understand English

Additional Information

If you would like more information on this clinical study, please refer to Dr. Hart’s website or to the trial listing on clinicaltrials.gov.

Principal Investigator

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@hivnet.ubc.ca.

Dr. Trevor Hart

Co-Leader, Prevention Core; Member, Steering Committee

Ryerson University; University of Toronto

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Participating Site

Here’s where this study is being conducted.