CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Reduction of social anxiety & substance use in gay/bi menbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02045225
NCT02045225Phase 1Completed

An HIV Prevention Intervention for HIV-negative Men Who Have Sex With Men Via Reduction of Social Anxiety and Substance Use in Sexual Situations

Toronto Metropolitan University·interventional·Posted Jan 24, 2014·Updated Mar 11, 2020

In Brief

A Phase 1 clinical trial evaluating Reduction of social anxiety & substance use in gay/bi men for Social Anxiety and Substance Use. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 24, 2014
Enrollment StartFeb 1, 2013
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.4 years ago

Interventions

Reduction of social anxiety & substance use in gay/bi menbehavioral

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.