Clinical trial NCT04718194: Developing Online Interventions to Reduce Stigma-Related Stress, Sexual Health, and HIV Risk Among Young Chinese MSM
Official title: Developing Efficient Intervention Technologies to Reduce Stigma-Related Stress, Mental Health Problems, and HIV Risk Among Young Chinese MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LGBTQ
Sexual Behavior
HIV Risk
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Central South University
name: Fogarty International Center of the National Institute of Health
First posted: 2021-01-22
Enrollment: 120
Sex: MALE
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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:

1. 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.
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Number of Past 90-Day Condomless Anal Sex Acts
timeFrame: Baseline, 4 months, 8 months
Secondary outcomes:
measure: Change in Number of Past 90-Day Condomless Anal Sex Acts With Casual Partners
timeFrame: Baseline, 4 months, 8 months
measure: Change in Depression
timeFrame: Baseline, 4 months, 8 months
measure: Change in Anxiety
timeFrame: Baseline, 4 months, 8 months
measure: Change in Disordered Alcohol Use
timeFrame: Baseline, 4 months, 8 months
measure: Change in Disordered Drug Use
timeFrame: Baseline, 4 months, 8 months
measure: Change in Suicidal Ideation
timeFrame: Baseline, 4 months, 8 months
measure: Change in Concealment Motivation
timeFrame: Baseline, 4 months, 8 months
measure: Change in Acceptance Concerns
timeFrame: Baseline, 4 months, 8 months
measure: Change in Internalized Homonegativity
timeFrame: Baseline, 4 months, 8 months
measure: Change in Emotion Dysregulation
timeFrame: Baseline, 4 months, 8 months
measure: Change in Perceived Social Support
timeFrame: Baseline, 4 months, 8 months
measure: Change in Rumination
timeFrame: Baseline, 4 months, 8 months
measure: Change in HIV/STI Testing
timeFrame: Baseline, 4 months, 8 months
measure: Change in Condom Use
timeFrame: Baseline, 4 months, 8 months
measure: Change in Safer Sex
timeFrame: Baseline, 4 months, 8 months
measure: Change in HIV Test Results
timeFrame: Baseline, 4 months, 8 months
measure: Change in Syphilis Test Results
timeFrame: Baseline, 4 months, 8 months
Other outcomes:
measure: Change in Depression Severity
timeFrame: Baseline, 4 months, 8 months
measure: Change in Anxiety Severity
timeFrame: Baseline, 4 months, 8 months
measure: Change in Self-Esteem
timeFrame: Baseline, 4 months, 8 months
Locations:
city: Hunan
country: China
facility: Central South University
Study officials:
affiliation: Yale University
name: John Pachankis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: