Developing Online Interventions to Reduce Stigma-Related Stress, Sexual Health, and HIV Risk Among Young Chinese MSM

NCT04718194 | Completed Results DMC

• 3 other identifiers: 20000294331R21TW011762-015R21TW011762-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

LGBTQ; Sexual Behavior; HIV Risk

Outcome Measures

Primary Outcomes (1)

• Change in Number of Past 90-Day Condomless Anal Sex Acts

  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.

  Baseline, 4 months, 8 months

Secondary Outcomes (17)

• Change in Number of Past 90-Day Condomless Anal Sex Acts With Casual Partners

  Baseline, 4 months, 8 months

• Change in Depression

  Baseline, 4 months, 8 months

• Change in Anxiety

  Baseline, 4 months, 8 months

• Change in Disordered Alcohol Use

  Baseline, 4 months, 8 months

• Change in Disordered Drug Use

  Baseline, 4 months, 8 months

Other Outcomes (3)

• Change in Depression Severity

  Baseline, 4 months, 8 months

• Change in Anxiety Severity

  Baseline, 4 months, 8 months

• Change in Self-Esteem

  Baseline, 4 months, 8 months

Study Arms (2)

ESTEEM iCBT

EXPERIMENTAL

The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.

Behavioral: ESTEEM iCBT

Self-monitoring

PLACEBO COMPARATOR

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

Behavioral: Self-monitoring control

Interventions

ESTEEM iCBT BEHAVIORAL

The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.

ESTEEM iCBT

Self-monitoring control BEHAVIORAL

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

Self-monitoring

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator
• Central South University: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Central South University

Hunan, China

Location

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

This trial was conducted during the COVID-19 pandemic and associated restrictive policies in China, which might have influenced intervention efficacy in ways unknown, although stress, mental health, and behavioral outcomes such as HIV-transmission-risk behavior have all been documented to have been influenced by the pandemic

Results Point of Contact

• Title: Dr. Dani Chiaramonte
• Organization: Yale

danielle.chiaramonte@yale.edu

3479310195

Study Officials

• John Pachankis, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 22, 2021
• Study Start: April 19, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 16, 2024
• Results First Posted: January 17, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available 12 months after study completion for three years.
• Access Criteria: Data access requests from qualified academic investigators for non-commercial research interests will be reviewed by study investigators. Requestors will be required to sign a data access agreement.

Locations

CN (1)