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LGBTQNCT04718194

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

A study testing ESTEEM iCBT in people with LGBTQ and Sexual Behavior, run by Yale University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
LGBTQ, Sexual Behavior, HIV Risk
What is being tested?
ESTEEM iCBT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
19 Apr 2021to 30 Nov 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Central South University

    Hunan

Other trials in China

About this study

Official title: Developing Efficient Intervention Technologies to Reduce Stigma-Related Stress, Mental Health Problems, and HIV Risk Among Young Chinese MSM

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.

Read the 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.

Being tested
ESTEEM iCBT, Self-monitoring control
Medical subject headings
Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ESTEEM iCBTBehavioural

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

  • Self-monitoring controlBehavioural

    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

Study groups in NCT04718194
Study groupRoleWhat they receive
ESTEEM iCBTExperimentalThe online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
Receives: Behavioral: ESTEEM iCBT
Self-monitoringPlacebo comparatorParticipants 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
Receives: Behavioral: Self-monitoring control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 4 months, 8 months

Secondary outcomes (17)
  1. Change in Number of Past 90-Day Condomless Anal Sex Acts With Casual Partners

    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 secondary outcome measure, condomless anal sex (CAS) with casual partners only will be determined.

    Measured: Baseline, 4 months, 8 months

  2. Change in Depression

    Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9). A sum score of 9 items indicates depression severity, with higher scores indicating higher severity and a scores ranging from 0-27. A 10th item indicates functional impairment. A cutoff score of 7 or more indicates high likelihood of a depressive episode.

    Measured: Baseline, 4 months, 8 months

  3. Change in Anxiety

    Anxiety will be measured using the Generalized Anxiety Disorder-7 scale (GAD-7). A sum score of 7 items indicates anxiety severity, with higher scores indicating higher severity and scores ranging from 0 to 21. An 8th item indicates functional impairment. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate, and severe anxiety, respectively.

    Measured: Baseline, 4 months, 8 months

  4. Change in Disordered Alcohol Use

    Disordered alcohol use will be assessed using the Alcohol Use Disorders Identification (AUDIT) instrument. The AUDIT consists of 10 items. Items 1 to 9 are scored 0, 1, 2, 3, or 4, and item 10 is scored 0, 2, or 4. Higher scores indicate greater alcohol use, with scores ranging from 0 to 40. Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence.

    Measured: Baseline, 4 months, 8 months

  5. Change in Disordered Drug Use

    Disordered drug use other than alcohol will be assessed using the Drug Use Disorders Identification (DUDIT) instrument. The DUDIT consists of 11 items. Items 1 to 9 are scored 0, 1, 2, 3, or 4, and items 10 and 11 are scored 0, 2, or 4. Higher scores indicate greater drug use, with scores ranging from 0 to 44. A score of 25 points or more is recommended as an indicator of drug dependence.

    Measured: Baseline, 4 months, 8 months

  6. Change in Suicidal Ideation

    Suicidal ideation will be measured using the Suicidal Ideation Attributes Scale (SIDAS). Total SIDAS scores are calculated as the sum of the five items, with controllability (item 2) reverse scored (10=0, 9=1, …, 0=10). Higher scores indicate greater suicidality, with total scores ranging from 0 to 50.

    Measured: Baseline, 4 months, 8 months

  7. Change in Concealment Motivation

    Motivation to conceal sexual minority identity will be assessed using the Concealment Motivation subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a total score, ranging from 1 to 6. Higher scores indicate higher concealment motivation.

    Measured: Baseline, 4 months, 8 months

  8. Change in Acceptance Concerns

    Acceptance concerns of sexual minority identity will be assessed using the Acceptance Concerns subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a total scores ranging from 1 to 6. Higher scores indicate higher acceptance concerns.

    Measured: Baseline, 4 months, 8 months

  9. Change in Internalized Homonegativity

    Internalized homonegativity will be assessed using the Internalized Homophobia subscale of the Lesbian, Gay, and Bisexual Identity Scale (LGBIS). The three subscale items, rated on a 6-point scale, will be averaged for a total scores, ranging from 1 to 6. Higher scores indicate higher internalized homonegativity.

    Measured: Baseline, 4 months, 8 months

  10. Change in Emotion Dysregulation

    Emotion dysregulation will be assessed using the 18-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF). Items are rated on a 5-point scale from 1-5; items 1, 4, and 6 are reverse coded. Items are summed for a total score, ranging from 18 to 90, where higher scores indicate higher emotion dysregulation.

    Measured: Baseline, 4 months, 8 months

  11. Change in Perceived Social Support

    Perceived social support will be measured using the 12-item Multidimensional Scale of Perceived Social Support (MPSS). Items are rated on a 7-point scale from 1-7 and averaged for a total score, ranging from 1 to 7, with higher scores indicating higher perceived social support.

    Measured: Baseline, 4 months, 8 months

  12. Change in Rumination

    Rumination will be measured using the 5-item Brooding Subscale of the Ruminative Responses Scale (RRS). Items are rated on a 4-point scale from 1-4 and summed for a total scores, ranging from 5 to 20, with higher scores indicating higher rumination.

    Measured: Baseline, 4 months, 8 months

  13. Change in HIV/STI Testing

    The Past 4-month HIV/STI Testing Questionnaire consists of 7 multiple choice questions previously developed by the study PI for another study asking participants about their HIV/STI testing history. The questionnaire consists of questions, such as, "Have you provided a urine sample as part of any STI test in the last 4 months" with response options of "yes," "no," or "I don't remember." Scores were coded with "yes" being 1 and "no" being 0, and and a total score was assessed as the average of all scores. Thus, total scores ranged from 0 to 1, with higher scores indicating greater HIV/STI testing in the past 4 months.

    Measured: Baseline, 4 months, 8 months

  14. Change in Condom Use

    The Decisional Balance for Condom Use Scale is an 18-item psychometrically validated scale measuring one's motivation to increase condom use (e.g., "I would feel bad if my friends found out I had sex without a condom"), with response options ranging between 1 = not at all to 5 = extremely. Scores are summed for a total scores, ranging from 18 to 90, with lower scores are indicative of greater likelihood to use a condom.

    Measured: Baseline, 4 months, 8 months

  15. Change in Safer Sex

    The Safer Sex Questionnaire is a psychometrically validated measure and consists of 13-items based on a 5-point Likert scale assessing one's confidence in avoiding having anal sex without a condom in various contexts. Scores are summed for a total score, ranging from 13 to 65, with higher scores are indicative of greater safer sex self-efficacy.

    Measured: Baseline, 4 months, 8 months

  16. Change in HIV Test Results

    Participants will be provided with self-administered rapid HIV testing kits at baseline and 8-months post-baseline to assess for incidence of HIV.

    Measured: Baseline, 4 months, 8 months

  17. Change in Syphilis Test Results

    Participants will be provided with self-administered rapid syphilis testing kits at baseline and 8-months post-baseline to assess for incidence of syphilis.

    Measured: Baseline, 4 months, 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start19 Apr 2021
  3. Primary completion30 Nov 2022
  4. Study completion30 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04718194
Sponsor's protocol ID
2000029433
Other IDs
1R21TW011762-01, 5R21TW011762-02
Status last verified
Feb 2024
First submitted
13 Jan 2021
Last updated
16 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Questions about this trial

What is this clinical trial studying?

A study testing ESTEEM iCBT in people with LGBTQ and Sexual Behavior, run by Yale University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Number of Past 90-Day Condomless Anal Sex Acts (time frame: Baseline, 4 months, 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.

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