Status:

UNKNOWN

Sexual Confidence: CBT for Social Anxiety Disorder With HIV Risk Reduction Counselling for HIV-negative gbMSM

Lead Sponsor:

Toronto Metropolitan University

Collaborating Sponsors:

University of British Columbia

Unity Health Toronto

Conditions:

Social Anxiety

Sexual Risk

Eligibility:

MALE

18+ years

Phase:

NA

Brief Summary

Given the continued high human immunodeficiency virus (HIV) prevalence rates among gay, bisexual, and other men who have sex with men (MSM) in North American cities, there is a critical need for HIV p...

Detailed Description

Gay, bisexual, and other men who have sex with men (MSM) continue to bear a disproportionate burden of the sexually transmitted infections (STI), such as HIV in Canada, largely attributable to efficie...

Eligibility Criteria

Inclusion

  • Participants must report engaging in CAS sex without PrEP with a man of HIV-positive or unknown HIV status within the last 3 months and report using substances within 2 hours before and/or during sexual activities. Participants must self-identify as a man (including trans\* men who self-identify as men), and be aged 18 or older.
  • To minimize bias, participants will be asked to report to the research study clinician in case they decide to engage in other psychotherapies outside of the study protocol or decide to change their psychoactive medication or dose for the duration of their participation in the study. Participants who participate in outside psychotherapies or who change their medication regimens will still be permitted to conclude the therapy, but their data will not be included in the RCT analyses.

Exclusion

  • As mentioned previously, participants taking PrEP will be excluded from participating. This excludes individuals 1) on daily PrEP dosing, with no more then 3 doses missed per week at the time of exposure and 2) on-demand dosing at the time of the exposure, including at least one dose before and after exposure. Participants need to score within 1 SD of the clinical mean (M = 67.2) for social anxiety disorder on the Liebowitz Social Anxiety Scale.
  • Persons will be excluded if our assessors/counsellors find that a participant's ability to respond to study measures is compromised by mental or physical disabilities or inability to speak and understand English.

Key Trial Info

Start Date :

December 15 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 30 2025

Estimated Enrollment :

176 Patients enrolled

Trial Details

Trial ID

NCT04381559

Start Date

December 15 2020

End Date

May 30 2025

Last Update

November 22 2023

Active Locations (1)

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1

Toronto Metropolitan University

Toronto, Ontario, Canada, M5B 1Y3