N/A N=120 Randomized Single-blind Health Services Research

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

LGBTQ · Sexual Behavior · HIV Risk

Bottom Line

View on ClinicalTrials.gov: NCT04718194 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Change in Number of Past 90-Day Condomless Anal Sex Acts — 1.98; 1.80; 0.58; 0.80 condomless anal sex acts

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ESTEEM iCBT (Behavioral); Self-monitoring control (Behavioral)
Age: Pediatric, Adult · 16+ yrs
Sex: Male
Sponsor: Yale University
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Number of Past 90-Day Condomless Anal Sex Acts	1.98; 1.80; 0.58; 0.80; 0.50; 0.65	—
SECONDARY Change in Number of Past 90-Day Condomless Anal Sex Acts With Casual Partners	.58; 0.50; .11; 0.22; 0; 0.08	—
SECONDARY Change in Depression	12.40; 10.40; 8.33; 10.00; 7.28; 10.00	—
SECONDARY Change in Anxiety	9.55; 9.03; 5.72; 8.80; 5.54; 8.47	—
SECONDARY Change in Disordered Alcohol Use	4.32; 4.88; 3.44; 4.68; 2.43; 5.30	—
SECONDARY Change in Disordered Drug Use	1.38; 1.97; 0.91; 1.40; 0.61; 1.33	—
SECONDARY Change in Suicidal Ideation	5.07; 5.47; 2.09; 4.17; 1.76; 2.97	—
SECONDARY Change in Concealment Motivation	4.66; 4.36; 4.59; 4.40; 4.55; 4.44	—
SECONDARY Change in Acceptance Concerns	4.73; 4.63; 4.38; 4.75; 4.36; 4.53	—
SECONDARY Change in Internalized Homonegativity	3.68; 3.19; 3.60; 3.37; 3.30; 3.22	—
SECONDARY Change in Emotion Dysregulation	55.9; 54.7; 50.0; 55.2; 48.2; 53.0	—
SECONDARY Change in Perceived Social Support	3.53; 3.66; 3.79; 3.49; 3.98; 3.81	—
SECONDARY Change in Rumination	13.9; 14.2; 12.6; 13.6; 12.3; 13.0	—
SECONDARY Change in HIV/STI Testing	0.850; 0.867; 0.815; 0.883; 0.870; 0.900	—
SECONDARY Change in Condom Use	61.2; 61.5; 59.1; 60.6; 57.4; 59.3	—
SECONDARY Change in Safer Sex	55.5; 55.9; 56.5; 57.1; 58.8; 57.9	—
SECONDARY Change in HIV Test Results	0; 0; 54; 60; 0; 0	—
SECONDARY Change in Syphilis Test Results	0; 1; 54; 59; 0; 1	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04718194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.