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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21TW011762-01 | U.S. NIH Grant/Contract | View source | |
| 5R21TW011762-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Central South University | OTHER |
| Fogarty International Center of the National Institute of Health | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESTEEM iCBT | Experimental | The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESTEEM iCBT | Behavioral | The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression Severity | 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. | Baseline, 4 months, 8 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Pachankis, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central South University | Hunan | China |
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available 12 months after study completion for three years.
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.
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All 120 participants who completed consent and were enrolled logged into the iCBT platform, completed the baseline survey, and were randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ESTEEM iCBT | ESTEEM iCBT: The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ESTEEM iCBT | ESTEEM iCBT: The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | condomless anal sex acts | Baseline, 4 months, 8 months |
|
Up to 8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ESTEEM iCBT | ESTEEM iCBT: The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dani Chiaramonte | Yale | 3479310195 | danielle.chiaramonte@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2022 | Nov 6, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2023 | Jan 28, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 5, 2022 | Feb 13, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 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 |
|
| Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| 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. | Baseline, 4 months, 8 months |
| Change in Anxiety Severity | 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. | Baseline, 4 months, 8 months |
| Change in Self-Esteem | 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. | Baseline, 4 months, 8 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Education Degree | Count of Participants | Participants |
|
| Marital/Relationship Status | Count of Participants | Participants |
|
| Estimated Income Per Month | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | ESTEEM iCBT | ESTEEM iCBT: The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. |
| OG001 | 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 |
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | condomless anal sex acts | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Count of Participants | Participants | Baseline, 4 months, 8 months |
|
|
|
| Secondary | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Count of Participants | Participants | Baseline, 4 months, 8 months |
|
|
|
| Other Pre-specified | Change in Depression Severity | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| Other Pre-specified | Change in Anxiety Severity | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| Other Pre-specified | Change in Self-Esteem | 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. | Intent to Treat Population (participants analyzed according to their original treatment assignment regardless of adherence to protocol) for all participants who completed 4/8-month follow-up assessments. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | 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 | 0 | 60 | 0 | 60 | 0 | 60 |
Not provided
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