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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH109413-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The intent of the proposed randomized controlled trial is to test the efficacy of a principle-based, transdiagnostic cognitive behavioral therapy (CBT) intervention that addresses the pathways through which minority stress compromises young gay and bisexual men's (YGBM) co-occurring mental (e.g., depression), behavioral (e.g., substance use), and sexual (e.g., condomless anal sex) health problems.
ESTEEM (Effective Skills to Empower Effective Men) is a 10-session skills-building intervention designed to reduce young gay and bisexual men's (YGBM) co-occurring health risks by reducing the underlying cognitive, affective, and behavioral pathways through which minority stress impairs YGBM's health. ESTEEM is based on the Unified Protocol, a cognitive-behavioral therapy (CBT) approach with efficacy across mental health and risk behaviors. In an initial study to create ESTEEM , the Unified Protocol was adapted by conducting interviews with 21 YGBM-expert mental health providers and 20 depressed, anxious YGBM at high risk for HIV infection. In a preliminary trial (NCT02448186), ESTEEM significantly reduced YGBM's spectrum of interrelated health threats, making it the first evidence-based intervention to simultaneously improve mental health, substance use, and sexual health outcomes among YGBM.
Important questions remain in order to validate the efficacy and potential cost-effectiveness of ESTEEM. Accordingly, we propose a 3-arm RCT that would examine (1) whether ESTEEM (arm 1) demonstrates significant improvements compared to existing LGBT-affirmative community mental health treatment (CMHT; arm 2) or standard HIV/STD voluntary counseling and testing (VCT; arm 3) for high-risk depressed and anxious YGBM and (2) whether it improves outcomes through reducing hypothesized cognitive, affective, and behavioral minority stress processes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESTEEM | Experimental | Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. |
|
| Community Mental Health Treatment (CMHT) | Active Comparator | Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. |
|
| Voluntary Counselling and Testing (VCT) | Active Comparator | Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESTEEM | Behavioral | ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. |
| Measure | Description | Time Frame |
|---|---|---|
| Any Condomless Anal Sex Acts | Our primary outcome is the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months. | 8 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Minority Stress: GRRS | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Test | Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at Baseline. | Baseline |
| HIV Test | Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at 12 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Pachankis, PhD | MYSM School Of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Public Health, Yale University | New Haven | Connecticut | 06520 | United States | ||
| Clinical Research Building, University of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36780265 | Derived | Keefe JR, Rodriguez-Seijas C, Jackson SD, Branstrom R, Harkness A, Safren SA, Hatzenbuehler ML, Pachankis JE. Moderators of LGBQ-affirmative cognitive behavioral therapy: ESTEEM is especially effective among Black and Latino sexual minority men. J Consult Clin Psychol. 2023 Mar;91(3):150-164. doi: 10.1037/ccp0000799. Epub 2023 Feb 13. | |
| 31399071 | Derived | Pachankis JE, McConocha EM, Reynolds JS, Winston R, Adeyinka O, Harkness A, Burton CL, Behari K, Sullivan TJ, Eldahan AI, Esserman DA, Hatzenbuehler ML, Safren SA. Project ESTEEM protocol: a randomized controlled trial of an LGBTQ-affirmative treatment for young adult sexual minority men's mental and sexual health. BMC Public Health. 2019 Aug 9;19(1):1086. doi: 10.1186/s12889-019-7346-4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ESTEEM | Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT). |
| FG001 | Community Mental Health Treatment (CMHT) | Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT). |
| FG002 | Voluntary Counselling and Testing (VCT) | Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The total number of participants randomized was 254, but 1 participant dropped out following randomization and did not complete the baseline interview.
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| ID | Title | Description |
|---|---|---|
| BG000 | ESTEEM | Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT). |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Any Condomless Anal Sex Acts | Our primary outcome is the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months. | Intention to Treat. One participant in each condition did not provide data for this outcome measure; overall number of participants analyzed does not include these participants. | Posted | Count of Participants | Participants | 8 Months |
|
12 Months
Severe Adverse Events were assessed systematically using the Brief Symptom inventory (BSI) and Suicidal Ideation Attributes Scale (SIDAS) during in-office assessments at 4MFU, 8MFU and 12MFU. Active suicidality also assessed through participant self-disclosure during therapy or during semi-structured clinical interviews (HAMD) during follow-up visits.
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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 | Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change. VCT: Voluntary Counselling and Testing (VCT). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Active Suicidality | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Pachankis, PhD | Yale University | (203) 785-3710 | john.pachankis@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 | Aug 5, 2020 | Oct 28, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2020 | Oct 28, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| CMHT | Behavioral | CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. |
|
| VCT | Behavioral | Voluntary Counselling and Testing (VCT). |
|
| Minority Stress: GRRS | Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress. | 4 Months |
| Minority Stress: GRRS | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress. | 8 Months |
| Minority Stress: GRRS | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress. | 12 Months |
| Minority Stress: IHS | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress. | Baseline |
| Minority Stress: IHS | Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress. | 4 Months |
| Minority Stress: IHS | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress. | 8 Months |
| Minority Stress: IHS | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress. | 12 Months |
| Minority Stress: SOCS | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment. | Baseline |
| Minority Stress: SOCS | Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment. | 4 Months |
| Minority Stress: SOCS | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment. | 8 Months |
| Minority Stress: SOCS | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment. | 12 Months |
| Minority Stress: DERS | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty. | Baseline |
| Minority Stress: DERS | Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty. | 4 Months |
| Minority Stress: DERS | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty. | 8 Months |
| Minority Stress: DERS | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty. | 12 Months |
| Minority Stress: Brooding | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity. | Baseline |
| Minority Stress: Brooding | Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity. | 4 Months |
| Minority Stress: Brooding | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity. | 8 Months |
| Minority Stress: Brooding | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity. | 12 Months |
| Minority Stress: Rathus Assertiveness Schedule | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness. | Baseline |
| Minority Stress: Rathus Assertiveness Schedule | Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness. | 4 Months |
| Minority Stress: Rathus Assertiveness Schedule | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness. | 8 Months |
| Minority Stress: Rathus Assertiveness Schedule | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness. | 12 Months |
| Any Condomless Anal Sex Acts | This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months. | Baseline |
| Any Condomless Anal Sex Acts | This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months. | 4 Months |
| Any Condomless Anal Sex Acts | This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months. | 12 Months |
| Safer Sex Self-Efficacy | HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed. | Baseline |
| Safer Sex Self-Efficacy | HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed. | 4 Months |
| Safer Sex Self-Efficacy | HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed. | 8 Months |
| Safer Sex Self-Efficacy | HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed. | 12 Months |
| Decisional Balance | HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex. | Baseline |
| Decisional Balance | HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex. | 4 Months |
| Decisional Balance | HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex. | 8 Months |
| Decisional Balance | HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex. | 12 Months |
| Depression: HAM-D | To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression. | Baseline |
| Depression: HAM-D | To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression. | 4 Months |
| Depression: HAM-D | To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression. | 8 Months |
| Depression: HAM-D | To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression. | 12 Months |
| Depression: BSI GSI | The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely). | Baseline |
| Depression: BSI GSI | The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely). | 4 Months |
| Depression: BSI GSI | The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely). | 8 Months |
| Depression: BSI GSI | The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely). | 12 Months |
| Substance Use: SIP-AD | Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15. | Baseline |
| Substance Use: SIP-AD | Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15. | 4 months |
| Substance Use: SIP-AD | Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15. | 8 Months |
| Substance Use: SIP-AD | Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15. | 12 Months |
| Any Pre-Exposure Prophylaxis (PrEP) Use | Participants will be asked if they had used PrEP in the last 3 months. | Baseline |
| Any Pre-Exposure Prophylaxis (PrEP) Use | Participants will be asked if they had used PrEP in the last 3 months. | 4 Months |
| Any Pre-Exposure Prophylaxis (PrEP) Use | Participants will be asked if they had used PrEP in the last 3 months. | 8 Months |
| Any Pre-Exposure Prophylaxis (PrEP) Use | Participants will be asked if they had used PrEP in the last 3 months. | 12 Months |
| 12 Months |
| Gonorrhea Test | Oral, rectal and urine samples will be collected to test participants for Gonorrhea at Baseline. | Baseline |
| Gonorrhea Test | Oral, rectal and urine samples will be collected to test participants for Gonorrhea at 12 months. | 12 Months |
| Chlamydia Test | Oral, rectal and urine samples will be collected to test participants for Chlamydia at Baseline. | Baseline |
| Chlamydia Test | Oral, rectal and urine samples will be collected to test participants for Chlamydia at 12 months. | 12 Months |
| Miami |
| Florida |
| 33136 |
| United States |
| BG001 | Voluntary Counselling and Testing (VCT) | Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT). |
| BG002 | Community Mental Health Treatment (CMHT) | Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy. The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. One participant in this arm did not complete baseline measures and is thus excluded in the baseline measures section. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Sex assigned at birth | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gender Identity | Gender identity variable was "check all that apply;" percent out of total sample size denoted for each identity. | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Diagnoses | All diagnoses presented, minus Substance-use disorder, were obtained using clinician-administered modules for listed disorders using the Mini-International Neuropsychiatric Interview for DSM-5 and ICD-10. Substance-use disorder was assessed for any of the following substance categories: stimulants, cocaine, opiates, hallucinogens, dissociatives, inhalants, cannabis, tranquilizers and miscellaneous. | Count of Participants | Participants |
|
| OG001 | Community Mental Health Treatment (CMHT) | Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT). |
| OG002 | Voluntary Counselling and Testing (VCT) | Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT). |
|
|
|
| Secondary | Minority Stress: GRRS | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Minority Stress: GRRS | Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress. | Posted | Mean | Standard Deviation | units on a scale | 4 Months |
|
|
|
| Secondary | Minority Stress: GRRS | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress. | Posted | Mean | Standard Deviation | units on a scale | 8 Months |
|
|
|
| Secondary | Minority Stress: GRRS | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| Secondary | Minority Stress: IHS | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Minority Stress: IHS | Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress. | Posted | Mean | Standard Deviation | units on a scale | 4 Months |
|
|
|
| Secondary | Minority Stress: IHS | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress. | Posted | Mean | Standard Deviation | units on a scale | 8 Months |
|
|
|
| Secondary | Minority Stress: IHS | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| Secondary | Minority Stress: SOCS | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Minority Stress: SOCS | Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment. | Posted | Mean | Standard Deviation | units on a scale | 4 Months |
|
|
|
| Secondary | Minority Stress: SOCS | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment. | Posted | Mean | Standard Deviation | units on a scale | 8 Months |
|
|
|
| Secondary | Minority Stress: SOCS | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| Secondary | Minority Stress: DERS | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Minority Stress: DERS | Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty. | Posted | Mean | Standard Deviation | units on a scale | 4 Months |
|
|
|
| Secondary | Minority Stress: DERS | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty. | Posted | Mean | Standard Deviation | units on a scale | 8 Months |
|
|
|
| Secondary | Minority Stress: DERS | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| Secondary | Minority Stress: Brooding | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Minority Stress: Brooding | Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity. | Posted | Mean | Standard Deviation | units on a scale | 4 Months |
|
|
|
| Secondary | Minority Stress: Brooding | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity. | Posted | Mean | Standard Deviation | units on a scale | 8 Months |
|
|
|
| Secondary | Minority Stress: Brooding | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| Secondary | Minority Stress: Rathus Assertiveness Schedule | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Minority Stress: Rathus Assertiveness Schedule | Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness. | Posted | Mean | Standard Deviation | units on a scale | 4 Months |
|
|
|
| Secondary | Minority Stress: Rathus Assertiveness Schedule | Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness. | Posted | Mean | Standard Deviation | units on a scale | 8 Months |
|
|
|
| Secondary | Minority Stress: Rathus Assertiveness Schedule | Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| Secondary | Any Condomless Anal Sex Acts | This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Any Condomless Anal Sex Acts | This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months. | Posted | Count of Participants | Participants | 4 Months |
|
|
|
| Secondary | Any Condomless Anal Sex Acts | This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months. | Participants with completed follow up visits. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | Safer Sex Self-Efficacy | HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Safer Sex Self-Efficacy | HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed. | Posted | Mean | Standard Deviation | units on a scale | 4 Months |
|
|
|
| Secondary | Safer Sex Self-Efficacy | HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed. | Posted | Mean | Standard Deviation | units on a scale | 8 Months |
|
|
|
| Secondary | Safer Sex Self-Efficacy | HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| Secondary | Decisional Balance | HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Decisional Balance | HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex. | Posted | Mean | Standard Deviation | units on a scale | 4 Months |
|
|
|
| Secondary | Decisional Balance | HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex. | Posted | Mean | Standard Deviation | units on a scale | 8 Months |
|
|
|
| Secondary | Decisional Balance | HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., "sex without a condom is more spontaneous") are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., "I could get infected with HIV if I have sex without a condom") are rate as important when making the decision to use condoms during anal sex. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| Secondary | Depression: HAM-D | To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Depression: HAM-D | To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression. | Posted | Mean | Standard Deviation | units on a scale | 4 Months |
|
|
|
| Secondary | Depression: HAM-D | To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression. | Posted | Mean | Standard Deviation | units on a scale | 8 Months |
|
|
|
| Secondary | Depression: HAM-D | To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| Secondary | Depression: BSI GSI | The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Depression: BSI GSI | The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely). | Posted | Mean | Standard Deviation | score on a scale | 4 Months |
|
|
|
| Secondary | Depression: BSI GSI | The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely). | Posted | Mean | Standard Deviation | score on a scale | 8 Months |
|
|
|
| Secondary | Depression: BSI GSI | The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (BSI) provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely). | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
|
|
|
| Secondary | Substance Use: SIP-AD | Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Substance Use: SIP-AD | Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15. | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
| Secondary | Substance Use: SIP-AD | Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15. | Posted | Mean | Standard Deviation | units on a scale | 8 Months |
|
|
|
| Secondary | Substance Use: SIP-AD | Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of "yes" responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., "I have failed to do what is expected of me because of my drinking/drug use"). Higher scores indicate greater substance use with a range of 0-15. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| Secondary | Any Pre-Exposure Prophylaxis (PrEP) Use | Participants will be asked if they had used PrEP in the last 3 months. | Participants that either completed or partially completed the interview. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Any Pre-Exposure Prophylaxis (PrEP) Use | Participants will be asked if they had used PrEP in the last 3 months. | Participants that either completed or partially completed the interview, MISSING used for those that either dropped our or partially completed the interview. | Posted | Count of Participants | Participants | 4 Months |
|
|
|
| Secondary | Any Pre-Exposure Prophylaxis (PrEP) Use | Participants will be asked if they had used PrEP in the last 3 months. | Participants that either completed or partially completed the interview, MISSING used for those that either dropped our or partially completed the interview. | Posted | Count of Participants | Participants | 8 Months |
|
|
|
| Secondary | Any Pre-Exposure Prophylaxis (PrEP) Use | Participants will be asked if they had used PrEP in the last 3 months. | Participants that either completed or partially completed the interview, MISSING used for those that either dropped our or partially completed the interview. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Other Pre-specified | HIV Test | Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at Baseline. | Participants with complete and valid data. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Other Pre-specified | HIV Test | Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at 12 months. | Participants with complete and valid data. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Other Pre-specified | Gonorrhea Test | Oral, rectal and urine samples will be collected to test participants for Gonorrhea at Baseline. | Participants with complete and valid data. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Other Pre-specified | Gonorrhea Test | Oral, rectal and urine samples will be collected to test participants for Gonorrhea at 12 months. | Participants with complete and valid data. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Other Pre-specified | Chlamydia Test | Oral, rectal and urine samples will be collected to test participants for Chlamydia at Baseline. | Participants with complete and valid data. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Other Pre-specified | Chlamydia Test | Oral, rectal and urine samples will be collected to test participants for Chlamydia at 12 months. | Participants with complete and valid data. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| 0 |
| 100 |
| 4 |
| 100 |
| 0 |
| 100 |
| EG001 | Voluntary Counselling and Testing (VCT) | Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM. VCT: Voluntary Counselling and Testing (VCT). | 0 | 52 | 0 | 52 | 0 | 52 |
| EG002 | Community Mental Health Treatment (CMHT) | Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association. VCT: Voluntary Counselling and Testing (VCT). | 0 | 102 | 1 | 102 | 0 | 102 |
Not provided
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| MISSING |
|
| MISSING ASSESSMENT |
|
| MISSING ASSESSMENT |
|
|
|
|
|
| I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months |
|
| I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago |
|
| I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months |
|
| I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago |
|
| MISSING ASSESSMENT |
|
|
| I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months |
|
| I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago |
|
| MISSING |
|
|
| I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months |
|
| I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago |
|
| MISSING |
|
| Inconclusive |
|
| Not Assessed |
|
| Rectal |
|
| Urine |
|
| Inconclusive |
|
| Not assessed |
|
| Rectal |
|
| Urine |
|
| Inconclusive |
|
| Not assessed |
|
| Rectal |
|
| Urine |
|
| Inconclusive |
|
| Not assessed |
|
| Rectal |
|
| Urine |
|