Cognitive Behavioral Therapy for Social Anxiety and HIV Risk Reduction in Gay and Bisexual Men
Integrating Cognitive-behavioural Therapy for Social Anxiety Disorder With HIV Risk Reduction Counselling for HIV-negative Gay and Bisexual Men Who Are at High Risk for HIV: A Randomized Controlled Trial.
This study is testing a new therapy that combines talking about feelings and HIV risk to help gay and bisexual men in Canada feel less anxious and reduce risky sexual behaviors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Toronto Metropolitan University Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04381559 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on addressing social anxiety and reducing HIV risk behaviors among gay, bisexual, and other men who have sex with men (MSM) in Canada. It combines cognitive behavioral therapy (CBT) with HIV risk reduction counseling to target the high prevalence of HIV and social anxiety within this population. The study aims to provide efficacy data for this novel integrated approach, which is designed to decrease condomless anal sex and substance use during sexual activities. Participants will engage in therapy while reporting their sexual behaviors and mental health status.
Who should consider this trial
Good fit: Ideal candidates are HIV-negative MSM aged 18 or older who have engaged in condomless anal sex and substance use in sexual situations within the last three months.
Not a fit: Patients currently taking PrEP or those who do not engage in the specified sexual behaviors may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce HIV transmission rates and improve mental health outcomes for MSM.
How similar studies have performed: While there have been studies addressing HIV prevention and social anxiety separately, this integrated approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toronto, Ontario
- Toronto Metropolitan University — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Trevor A Hart, Ph.D, CPsych — Toronto Metropolitan University
- Study coordinator: Jane Cao
- Email: hivprevmanager@torontomu.ca
- Phone: 4169795000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.