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

Launched by TORONTO METROPOLITAN UNIVERSITY · May 5, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help gay, bisexual, and other men who have sex with men (MSM) who struggle with social anxiety and are at risk for HIV. The goal is to see if combining a well-known therapy called cognitive-behavioral therapy (CBT) with counseling for reducing HIV risk can help participants feel more confident in social situations and make safer choices regarding their sexual health. The study will include 176 participants who will be divided into two groups: one will receive the combined therapy, while the other will receive a different treatment that focuses only on social anxiety without addressing HIV risk.

To be eligible for this trial, participants need to be HIV-negative men aged 18 or older, who have experienced significant social anxiety, engaged in condomless anal sex with partners of unknown HIV status within the last three months, and used substances shortly before or during sexual activities. Those on HIV prevention medication called PrEP will not be able to participate. Throughout the trial, participants can expect to attend 12 therapy sessions over several weeks, where they will learn skills to manage anxiety and improve their sexual health behaviors. The findings from this study could lead to better mental health and HIV prevention strategies specifically tailored for MSM.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.