Developing Efficient Intervention Technologies to Reduce Stigma-Related Stress, Mental Health Problems, and HIV Risk Among Young Chinese MSM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Number of Past 90-Day Condomless Anal Sex Acts
研究概览
简要总结
This study is a 2-arm RCT that will assess the efficacy of a culturally adapted, 10-session SGM-affirmative, internet-based cognitive behavioral therapy (iCBT) among young men who have sex with men (YMSM) in Hunan province China. The affirmative treatment called ESTEEM is based on a minority stress-focused, CBT framework. In collaboration with colleagues at Central South University (CSU), the investigators will assess whether a culturally adapted version of iCBT ESTEEM demonstrates significant reductions in HIV risk behavior and mental health symptoms (e.g., depression, anxiety) compared to self-monitoring of stress and mood.
详细描述
The primary objective is to evaluate the preliminary efficacy of a Chinese-adapted version of iCBT ESTEEM on YMSM's sexual health and HIV risk behavior. The secondary objectives of this study are to determine whether iCBT ESTEEM impacts HIV/sexually transmitted infections (STI) results and symptoms of depression and anxiety, as well as whether baseline minority stress exposure moderates treatment efficacy, such that participants with the most minority stress exposure benefit more from iCBT ESTEEM than those in the self-monitoring of stress and mood condition.
The proposed prospective study will follow a 2-arm RCT design where 120 Chinese YMSM participants will be randomly assigned to one of two conditions:
- ESTEEM iCBT: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. Modules contain weekly psychoeducational text and vignettes about minority stress and mental health; brief videos illustrating the CBT skills; and homework exercises that therapists review and provide feedback on. Homework exercises include weekly tracking of stress and mood, practicing new skills (e.g., mindfulness, cognitive restructuring), and exercises related to considering the origins of stress and negative emotions that participants may be experiencing. Therapists provide feedback after each homework assignment, including reviewing each participant's treatment goals as part of the first session's homework. Therapists who support this condition will be instructed to incorporate SGM-specific content and feedback into homework reviews. In the US, modules were adapted directly from the in-person materials (e.g., therapist manual, participant handouts) used in our previously successful trials of this treatment. The treatment has also been recently culturally adapted for in-person treatment among Chinese YMSM and found to be acceptable and feasible.
- Self-monitoring control: In this control condition, participants will be asked to indicate their past 7-day mood, stress experiences, and mental and behavioral health on an online survey. This type of self-monitoring has been shown to yield improvement in behavioral health outcomes. Self-reporting SGM stress experiences has also been shown to produce reductions in depression symptoms over time. Participants will record these experiences once per week for 10 weeks.
Before the full trial is launched, the investigators will ensure comprehension of the ESTEEM iCBT online module material with 10 separate YMSM, as well as gather their feedback on the usability of the iCBT online platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 30 Years(Child, Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •16-30 years old
- •Live in Hunan province China
- •Current gender identity as male
- •Report past 12-month sex with men
- •Be confirmed HIV-negative upon at-home testing
- •Report past 3-month condomless/PrEP-less anal sex
- •Past-week symptoms of depression or anxiety using the Brief Symptom Inventory-4 cutoff of 2.5 on either the depression subscale, anxiety subscale, or both
- •No past 3-month mental health services of more than 2 visits per month
- •Weekly access to internet on a laptop, desktop, or tablet device
- •Ability to read, write, and speak in Mandarin
- •Provision of informed consent
排除标准
- •Current active suicidality or homicidality (defined as active intent or concrete plan, as opposed to passive ideation)
- •Evidence of active and untreated mania or psychosis that could interfere with the participant's ability to volitionally consent to research or interfere with their ability to safely and reliably complete research
研究组 & 干预措施
ESTEEM iCBT
The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
干预措施: ESTEEM iCBT (Behavioral)
Self-monitoring
Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
干预措施: Self-monitoring control (Behavioral)
结局指标
主要结局
Change in Number of Past 90-Day Condomless Anal Sex Acts
时间窗: Baseline, 4 months, 8 months
The Timeline Follow-Back (TLFB) assesses retrospective estimates of HIV-related sexual behavior in the past 30 days. The TLFB was originally developed in interview format, but has been adapted as online self-report questionnaire. Participants report on daily partner type (e.g. main, casual), type of sexual behavior (e.g. insertive anal sex, receptive anal sex, oral sex), and condom use. The TLFB has good test-retest reliability, convergent validity, and agreement with collateral reports for HIV-related sexual behavior. Administration time ranges from 10-30 minutes. For this primary outcome measure, condomless anal sex (CAS) with main or casual partners will be determined. The primary comparison will be change in the number of CAS acts from baseline to 8 months post-baseline.
次要结局
- Change in Depression(Baseline, 4 months, 8 months)
- Change in Anxiety(Baseline, 4 months, 8 months)
- Change in Disordered Drug Use(Baseline, 4 months, 8 months)
- Change in Suicidal Ideation(Baseline, 4 months, 8 months)
- Change in Number of Past 90-Day Condomless Anal Sex Acts With Casual Partners(Baseline, 4 months, 8 months)
- Change in Concealment Motivation(Baseline, 4 months, 8 months)
- Change in HIV/STI Testing(Baseline, 4 months, 8 months)
- Change in HIV Test Results(Baseline, 4 months, 8 months)
- Change in Perceived Social Support(Baseline, 4 months, 8 months)
- Change in Rumination(Baseline, 4 months, 8 months)
- Change in Disordered Alcohol Use(Baseline, 4 months, 8 months)
- Change in Condom Use(Baseline, 4 months, 8 months)
- Change in Acceptance Concerns(Baseline, 4 months, 8 months)
- Change in Internalized Homonegativity(Baseline, 4 months, 8 months)
- Change in Safer Sex(Baseline, 4 months, 8 months)
- Change in Emotion Dysregulation(Baseline, 4 months, 8 months)
- Change in Syphilis Test Results(Baseline, 4 months, 8 months)
