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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04718194

Enrollment

120

Registered

2021-01-22

Start date

2021-04-19

Completion date

2022-11-30

Last updated

2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Risk, LGBTQ, Sexual Behavior

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.

Interventions

BEHAVIORALESTEEM iCBT

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

BEHAVIORALSelf-monitoring control

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

16 Years to 30 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Number of Past 90-Day Condomless Anal Sex Acts	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.

Secondary

Measure	Time frame	Description
Change in Acceptance Concerns	Baseline, 4 months, 8 months	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.
Change in Safer Sex	Baseline, 4 months, 8 months	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.
Change in HIV Test Results	Baseline, 4 months, 8 months	Participants will be provided with self-administered rapid HIV testing kits at baseline and 8-months post-baseline to assess for incidence of HIV.
Change in Syphilis Test Results	Baseline, 4 months, 8 months	Participants will be provided with self-administered rapid syphilis testing kits at baseline and 8-months post-baseline to assess for incidence of syphilis.
Change in Number of Past 90-Day Condomless Anal Sex Acts With Casual Partners	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 secondary outcome measure, condomless anal sex (CAS) with casual partners only will be determined.
Change in Depression	Baseline, 4 months, 8 months	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.
Change in Anxiety	Baseline, 4 months, 8 months	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.
Change in Disordered Alcohol Use	Baseline, 4 months, 8 months	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.
Change in Disordered Drug Use	Baseline, 4 months, 8 months	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.
Change in Suicidal Ideation	Baseline, 4 months, 8 months	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.
Change in Concealment Motivation	Baseline, 4 months, 8 months	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.
Change in Internalized Homonegativity	Baseline, 4 months, 8 months	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.
Change in Emotion Dysregulation	Baseline, 4 months, 8 months	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.
Change in Perceived Social Support	Baseline, 4 months, 8 months	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.
Change in Rumination	Baseline, 4 months, 8 months	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.
Change in HIV/STI Testing	Baseline, 4 months, 8 months	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.
Change in Condom Use	Baseline, 4 months, 8 months	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.

Other

Measure	Time frame	Description
Change in Self-Esteem	Baseline, 4 months, 8 months	As an exploratory outcome, self-esteem will be measured using the 10-item Rosenberg Self-Esteem Scale. Items are rated on a 4 point scale from 0-3; items 4, 6, 9, 10, and 11 are reverse scored. Items are summed for a total score ranging from 0 to 30, where a higher score indicates greater self-esteem.
Change in Anxiety Severity	Baseline, 4 months, 8 months	As an exploratory outcome, anxiety severity will be measured by the Overall Anxiety Severity & Impairment Scale (OASIS). This 5 item measure uses a 0-4 rating scale and sums across the items for a total score ranging from 0 to 20. Higher scores indicate greater severity of anxiety.
Change in Depression Severity	Baseline, 4 months, 8 months	As an exploratory outcome, depression severity will be measured using the Overall Depression Severity & Impairment Scale (ODSIS). This 5 item measure uses a 0-4 rating scale and sums across the items for a total score ranging from 0 to 20. Higher scores indicate greater severity of depression.

Countries

China

Participant flow

Recruitment details

Participants were recruited via online and paper advertisements on social networking platforms and in the lobbies of LGBTQ+ friendly organizations. 425 prospective participants completed the initial online screener.

Pre-assignment details

All 120 participants who completed consent and were enrolled logged into the iCBT platform, completed the baseline survey, and were randomized.

Participants by arm

Arm	Count
ESTEEM iCBT ESTEEM iCBT: The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.	60
Self-monitoring Self-monitoring control: 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	60
Total	120

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	3	0
Overall Study	Withdrawal by Subject	3	0

Baseline characteristics

Characteristic	Self-monitoring	Total	ESTEEM iCBT
Age, Continuous	22.72 years STANDARD_DEVIATION 3.09	23.22 years STANDARD_DEVIATION 3.26	23.73 years STANDARD_DEVIATION 3.36
Education Degree College/four-year university	47 Participants	91 Participants	44 Participants
Education Degree Graduate school or above	6 Participants	13 Participants	7 Participants
Education Degree High school/vocational school	6 Participants	15 Participants	9 Participants
Education Degree Junior high school or less	1 Participants	1 Participants	0 Participants
Employment Status Full-time job	29 Participants	55 Participants	26 Participants
Employment Status Part-time job	4 Participants	9 Participants	5 Participants
Employment Status Student	24 Participants	50 Participants	26 Participants
Employment Status Unemployed	3 Participants	6 Participants	3 Participants
Estimated Income Per Month 3000-5000	17 Participants	31 Participants	14 Participants
Estimated Income Per Month <3000RMB	29 Participants	59 Participants	30 Participants
Estimated Income Per Month 5000-800	8 Participants	17 Participants	9 Participants
Estimated Income Per Month >8000RMB	6 Participants	13 Participants	7 Participants
Marital/Relationship Status Divorced	0 Participants	2 Participants	2 Participants
Marital/Relationship Status Married	3 Participants	5 Participants	2 Participants
Marital/Relationship Status Single, but having regular partner	33 Participants	67 Participants	34 Participants
Marital/Relationship Status Single, without a regular partner	24 Participants	46 Participants	22 Participants
Race/Ethnicity, Customized Ethnicity Han nationality	55 Participants	113 Participants	58 Participants
Race/Ethnicity, Customized Ethnicity Hmong/Miao minority	1 Participants	3 Participants	2 Participants
Race/Ethnicity, Customized Ethnicity Hui minority	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Ethnicity Tujia minority	3 Participants	3 Participants	0 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	60 Participants	120 Participants	60 Participants
Sexual Orientation Bisexual	7 Participants	10 Participants	3 Participants
Sexual Orientation Gay/homosexual	53 Participants	110 Participants	57 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 60	0 / 60
other Total, other adverse events	0 / 60	0 / 60
serious Total, serious adverse events	0 / 60	0 / 60

Outcome results

Primary

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.