Social Anxiety | HIV Prevention for HIV-Negative Men Via Reduction of Social Anxiety
Social Anxiety research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral: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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Cognitive behavioural therapy
Start Date: February 2013
Completed Date: June 2017
Phase: Phase 1
Primary Outcome: Instances of unprotected anal intercourse with sexual partners who are HIV-positive or of unknown HIV status
Secondary Outcome: Severity of social anxiety and instances substance use in sexual situations
Study sponsors, principal investigator, and references
Principal Investigator: Trevor A Hart, PhD
Lead Sponsor: Ryerson University
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.