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临床试验/NCT04381559
NCT04381559招募中不适用

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.

Toronto Metropolitan University2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2020年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
176
试验地点
2
主要终点
Condomless Anal Sex with partners of unknown or HIV-positive status, without participant use of PrEP, based on response at 6 months (yes/no).

研究概览

简要总结

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.

详细描述

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 efficient transmission during condomless anal sex (CAS). Despite overall declines in HIV incidence since 2005, HIV incidence among MSM remains stable. In 2016, MSM accounted for 52.5% of new HIV diagnoses in Canada, compared with 56.8% in 2014. MSM also represent over half of all prevalent HIV cases. The HIV epidemic among MSM has failed to decline despite biomedically-driven efforts to reduce infectiousness through the proliferation of antiretroviral Treatment as Prevention, and the emergence of HIV Pre-Exposure Prophylaxis (PrEP) to reduce HIV susceptibility. The epidemiologic data underscore the need for efficacious interventions for reducing sexual risk behaviour among MSM. The Public Health Agency of Canada (PHAC) has therefore identified MSM as a high priority population to reach with prevention initiatives.

Social anxiety is a risk factor for CAS among MSM. It is typically defined as the experience of fear of and apprehension about being evaluated in interpersonal situations, including romantic or sexual relationships. Social anxiety is higher among gay men and other sexual minority populations than among heterosexuals on both dimensional measures and categorical measures, with recent studies reporting the prevalence of social anxiety disorders among MSM as 22.3-22.9%.

Social anxiety predicts risky sex among MSM. Research suggests a direct relation between social anxiety and CAS among MSM. Social anxiety was associated with a greater proportion of receptive and insertive CAS even after adjusting for condom use negotiation, depression, and club drug use. Social anxiety may also increase substance use in sexual situations, which is another risk factor for HIV among MSM. However, no studies have examined the efficacy of social anxiety treatment on CAS among MSM. Social anxiety is highly modifiable via cognitive-behavioural therapy (CBT).

Fears of being sexually rejected by one's partner fully accounted for the association between social anxiety at baseline and CAS at 6-month follow-up. This study is consistent with previous findings that 32% of gay men reported being less likely to use condoms when they were concerned their partner would react negatively. Substance use may be another mediator. Social anxiety is also a risk factor for later alcohol use and other substance use problems in clinical and nonclinical samples, including among MSM. Substance use tends to follow social anxiety disorder because alcohol and other substances are used to self-medicate anxiety symptoms in social situations. Alcohol and substance use in sexual situations is a relatively consistent risk factor for CAS among Canadian MSM, as well as higher HIV incidence. Due to consistent data linking substance use to HIV risks, it has been suggested that incorporating alcohol and substance use treatment into sexual risk reduction counselling may increase the efficacy of HIV prevention efforts for MSM. Social anxiety may have a specific relationship with substance use in creating risk for HIV and other STIs.

The present study will provide efficacy data for a novel and innovative STI/HIV prevention intervention for MSM. This intervention, called Sexual Confidence, builds upon empirically supported treatments for social anxiety, including social anxiety-related substance use, by adding risk reduction counselling to reduce STI/HIV sexual risk behaviour.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Counsellors cannot be blinded as they are providing treatment, however assessors will be blinded to treatment condition. Participants will not be provided with details on the treatment condition to which they were not assigned to minimize the possibility that participant beliefs about which condition is better will impact outcomes.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Condomless Anal Sex with partners of unknown or HIV-positive status, without participant use of PrEP, based on response at 6 months (yes/no).

时间窗: 6-months follow-up

Participants will indicate frequency of and number of sexual partners for 1) insertive and receptive anal sex and vaginal or frontal sex both with and without a condom, in the past 3 months. For each of these 3 sexual behaviours, we will ask whether the sexual behaviour was with partners who were HIV-positive, HIV-negative, or of unknown serostatus. Participants will also be asked if they had insertive or receptive CAS or condomless vaginal or frontal sex with their last sex partner, as well as the HIV status of the person with whom they last had CAS or condomless vaginal or frontal sex. A draft of this measure is included in the "Questionnaire" document.

次要结局

  • Social Anxiety Measures(baseline, 14 weeks, 3- and 6- month follow-up)
  • Self-report measures(baseline, 14 weeks, 3- and 6- month follow-up)
  • The Structured Clinical Interview for DSM-5 Disorders (SCID-5)(baseline, 14 weeks, 3- and 6- month follow-up)
  • Yale Adherence & Competence Scale-II Cognitive Behavioural Therapy Scales(3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks)
  • 11.5 Cumulative incidence of bacterial STIs and incidence of HIV and viral hepatitis(baseline, 14 weeks, 3- and 6- month follow-up)
  • Qualitative Exit Interview(6-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Trevor Hart

Principal Investigator

Toronto Metropolitan University

研究点 (2)

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