CTN 318: Sexual Confidence Randomized Controlled Trial
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
About the Study
This study will examine the effectiveness of using CBT combined with HIV risk reduction counselling to simultaneously treat social anxiety disorder, substance use disorders, and HIV sexual risk behaviour. The researchers will compare this intervention with applied relaxation ” a behavioural intervention that can effectively treat social anxiety disorder but does not focus on substance use or HIV sexual risk behaviours. If successful, the study will provide data for new and innovative HIV prevention strategies for gay, bisexual, and other men who have sex with men (gbMSM).
Background
In Canada, sexually transmitted infections (STIs) and HIV disproportionately affect (gbMSM). It is thought that this is largely due to efficient transmission of infections during condomless anal sex (CAS). Research suggests that CAS between gbMSM may be linked to social anxiety, which is anxiety in social situations. Social anxiety may in turn increase the likelihood of substance use in sexual situations, which carries its own risk for HIV transmission.
High social anxiety can be treated using cognitive behavioural therapy (CBT) and applied relaxation. However, to date, only one small study has examined the effectiveness of social anxiety treatment on CAS among gbMSM.
Study Approach
This study will aim to recruit 44 participants per year, to reach a total of 176 HIV-negative gbMSM over a four-year period. The participants will be randomized to either 12 sessions of CBT or 12 sessions of applied relaxation. Assessments will take place at baseline, following the intervention sessions, and three and six months after the intervention. The assessments will include interviews, laboratory testing, and self-reported measures of social anxiety, substance use in sexual situations, and sexual risk behaviours.
If you would like more information on this clinical study, please contact the study coordinator.
Eligibility Requirements
Required
- HIV-negative
- 18-65 years of age
- Had anal sex without a condom and without the use of PrEP with a man who was either 1) HIV-positive or 2) of unknown HIV status
- Had this type of sex at least once in the past three months (not including sex with a monogamous partner)
- Experienced social anxiety in the past month
- Used alcohol or other substance(s) within two hours of sexual activity at least once in the past three months.
- Able to read, speak, and understand spoken English.
Investigators
Here’s who is leading this study.
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