A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 4
- 主要终点
- Any Condomless Anal Sex Acts
研究概览
简要总结
The intent of the proposed randomized controlled trial is to test the efficacy of a principle-based, transdiagnostic cognitive behavioral therapy (CBT) intervention that addresses the pathways through which minority stress compromises young gay and bisexual men's (YGBM) co-occurring mental (e.g., depression), behavioral (e.g., substance use), and sexual (e.g., condomless anal sex) health problems.
详细描述
ESTEEM (Effective Skills to Empower Effective Men) is a 10-session skills-building intervention designed to reduce young gay and bisexual men's (YGBM) co-occurring health risks by reducing the underlying cognitive, affective, and behavioral pathways through which minority stress impairs YGBM's health. ESTEEM is based on the Unified Protocol, a cognitive-behavioral therapy (CBT) approach with efficacy across mental health and risk behaviors. In an initial study to create ESTEEM , the Unified Protocol was adapted by conducting interviews with 21 YGBM-expert mental health providers and 20 depressed, anxious YGBM at high risk for HIV infection. In a preliminary trial (NCT02448186), ESTEEM significantly reduced YGBM's spectrum of interrelated health threats, making it the first evidence-based intervention to simultaneously improve mental health, substance use, and sexual health outcomes among YGBM.
Important questions remain in order to validate the efficacy and potential cost-effectiveness of ESTEEM. Accordingly, we propose a 3-arm RCT that would examine (1) whether ESTEEM (arm 1) demonstrates significant improvements compared to existing LGBT-affirmative community mental health treatment (CMHT; arm 2) or standard HIV/STD voluntary counseling and testing (VCT; arm 3) for high-risk depressed and anxious YGBM and (2) whether it improves outcomes through reducing hypothesized cognitive, affective, and behavioral minority stress processes.
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)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •self-identification as a gay, bisexual or queer man;
- •HIV-negative status confirmed through in-office testing;
- •diagnosis of any DSM-5 depressive, anxiety, or trauma-/stress-related disorder;
- •risk of HIV transmission through sexual activity (≥ 1 act of past-90-day-condomless anal sex involving a flesh penis with a partner with an unknown HIV status or an HIV-positive status, unless with an HIV-positive primary or main partner with known undetectable viral load or an HIV-negative primary or main partner who is known to be adherent to PrEP);
- •not themselves currently adherent to PrEP (defined as taking PrEP on ≥ 4 days/week);
- •NYC or Miami residential stability and planned availability for 12 months;
- •English-language proficiency; and (9) provision of informed consent.
排除标准
- •current active suicidality or homicidality (but not passive suicidality);
- •evidence of active untreated mania, psychosis, or gross cognitive impairment;
- •current enrollment in another intervention study;
- •currently receiving 1 or more mental health treatment sessions/month or 8 or more CBT sessions within the past year;
- •HIV-positive status (confirmed through in-office testing).
结局指标
主要结局
Any Condomless Anal Sex Acts
时间窗: 8 Months
Our primary outcome is the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.
次要结局
- Minority Stress: GRRS(12 Months)
- Minority Stress: IHS(12 Months)
- Depression: HAM-D(12 Months)
- Minority Stress: Rathus Assertiveness Schedule(12 Months)
- Any Pre-Exposure Prophylaxis (PrEP) Use(12 Months)
- Minority Stress: SOCS(12 Months)
- Safer Sex Self-Efficacy(12 Months)
- Decisional Balance(12 Months)
- Minority Stress: DERS(12 Months)
- Minority Stress: Brooding(12 Months)
- Substance Use: SIP-AD(12 Months)
- Any Condomless Anal Sex Acts(12 Months)
- Depression: BSI GSI(12 Months)