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

HIV | Social Anxiety | Sexual Risk

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 prevention interventions for MSM in Canada. Social anxiety, or anxiety about being evaluated in interpersonal and performance situations, is a reliable risk factor for condomless anal sex (CAS) among MSM. Social anxiety may also increase substance use in sexual situations, which is another risk factor for HIV among MSM. As such, an empirically-based social anxiety treatment may also reduce HIV risk behaviours among MSM. The present study will provide the first efficacy data for a novel and innovative HIV prevention intervention for MSM. This intervention will build upon empirically supported interventions to reduce HIV risk among MSM and therapies to reduce social anxiety. The investigators propose to test the efficacy of a novel integrated HIV prevention intervention that combines the most empirically supported treatment for social anxiety disorder, cognitive-behavioural therapy, with HIV risk reduction counselling in order to simultaneously treat social anxiety disorder, substance use disorders, and HIV sexual risk behaviour. This study will be a randomized controlled trial comparing the study intervention relative to applied relaxation, a behavioural intervention that is efficacious in treating social anxiety disorder but that does not address substance use problems or HIV sexual risk behaviours. For this trial, 176 participants will be randomized to either 12 sessions of cognitive-behavioural therapy with HIV risk reduction counselling or 12 sessions of applied relaxation.

Participants will be eligible for the trial if they are HIV-negative, report clinically significant symptoms of social anxiety disorder, substance use 2 hours before or during sexual activity, and CAS without the use of pre-exposure prophylaxis (PrEP) with a male partner who was not known to be HIV-negative. PrEP is a biomedical prevention approach in which HIV-negative individuals are provided with daily oral antiretroviral medication for the primary prevention of HIV.126 The present intervention, if found to be efficacious, is innovative in that mental health clinicians will be able to not only extend empirically supported therapies tested primarily with heterosexual populations to MSM, but they will also be able to prevent HIV through empirically supported psychotherapy practice.

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Conditions de participation

  • Sexe:

    MALE

  • Âges admissibles:

    18 and up

Critères de participation

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.

Lieu de l'étude

Toronto Metropolitan University
Toronto Metropolitan University
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Backup Contact

Allison Kirschbaum, PhD

[email protected]
4169795000
Primary Contact

Jane Cao

[email protected]
4169795000
Étude parrainée par
Toronto Metropolitan University
Participants recherchés
Plus d'informations
ID de l'étude: NCT04381559