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| ID | Type | Description | Link |
|---|---|---|---|
| P30MH062294-11 | 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 purpose of this study is adapt an evidence-based intervention for stigma-related stress, mental health, and HIV risk for bay, bisexual, and other men who have sex with men (MSM) of color in small urban areas.
This study has two specific aims. Aim 1 will focus on the modification of an existing intervention manual (created by the study PI) using feedback from previous qualitative interviews with MSM in New Haven and Hartford, CT. Also incorporated will be recent qualitative research on MSM of color's resilience. Specifically, the ways in which racial minority stigma impacts the mental health of MSM in small urban areas and adaptive coping skills that MSM can use in the face of these health threats.
Aim 2, will consist of the deliver of the adapted intervention to approximately 30 young MSM (15 HIV-negative and 15 HIV-positive) to gather data on the feasibility and acceptability of the newly adapted program. The evaluation of the new program will be conducted using pre-post comparisons of quantitative assessments and from qualitative interviews hoped to provide information regarding intervention feasibility, acceptability, and any needed refinement.
This project integrates expertise in culturally-sensitive evidence-based interventions for MSM's HIV risk into a community-based HIV prevention and care context at the Fair Haven Community Health Center, where the intervention will be delivered to the existing patient population.
As of April, 2019, the study protocol was updated and approved by the Yale IRB such that the two intervention cohorts did not differ by HIV serostatus. This decision was made: (1) because of the greater number of HIV-negative men, compared to HIV-positive men, who expressed interest in the study and (2) because participants could decide whether or not to disclose their serostatus in the group, as they do in other real-life interactions with other MSM, as reviewed during the consent process. Thus, there was no group assignment based on HIV serostatus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young gay and bisexual men of color | Experimental | Approximately 30 young MSM of color will take part in weekly 90-minute group treatment sessions over 10 weeks. All participants will complete outcome assessments at baseline and three months post-treatment, as well as an exit interview. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESTEEM conneCT | Behavioral | The intervention adapts the ESTEEM (Pachankis et al, 2015) intervention to address the multiple-stigma stressors faced by MSM of color, including sexual orientation and racial stigma in a manualized, CBT-based intervention. Approximately thirty participants (divided between two cohorts) will complete ten group sessions will take place at regular times once per week over the course of three months. The groups will be "closed," in that no new members will be allowed to join after the first week in order to promote open self-disclosure and trust among group members. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | To measure depression in participants, the Center for Epidemiological Studies - Depression Scale (CES-D) will be used. An overall depression score is computed as the sum of the 20 items, with Items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums were computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A higher score indicates more depressive symptomatology during the past week. Range is 0 - 60. | 3 months |
| HIV Transmission Risk | Risk of HIV transmission was assessed through the Past-90-day Timeline Follow-back interview (TLFB; Sobell & Sobell, 1992). HIV risk behavior was calculated as the number of past-90-day sex acts in which key harm-reduction strategies were not employed (e.g., condom, PrEP, viral load suppression) and calculated by dividing the total number of sex acts at risk for HIV transmission by the total number of sex acts. Sex acts range from 0 to (theoretically) infinite. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Depression Severity and Impairment Scale | ODSIS (Bentley et al., 2014) is a 5-item scale that asks individuals to rate the severity and impairment associated with past-week symptoms of depression (e.g., "In the past week, when you have felt depressed, how intense or severe was your depression?) from 0 (little or none: Depression was absent or barely noticeable.) to 4 (extreme: Depression was overwhelming.). Scores range from 0-20, with higher scores indicating greater depression and associated impairment in the past week. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Use | Participants indicated whether they had been adherent to PrEP in the past three months. | 3 months |
Inclusion Criteria:
Participants must:
Exclusion Criteria:
Identify as men, regardless of sex assigned at birth
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| Name | Affiliation | Role |
|---|---|---|
| John Pachankis, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States |
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Participants (n = 468) completed an online screener and were contacted for a phone screening (n = 139). Participants who met study inclusion criteria and consented to participate were invited to complete the baseline assessment prior to group assignment (n = 21).
Participants were recruited for the study between September 2018 and February 2019 through local community organizations (e.g., flyers poster at community health clinics, LGBTQ community organizations, university LGBTQ centers) and online (i.e., advertisements posted to Grindr and LGNTQ Facebook groups). Potential participants received a link to a secure online eligibility survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | ESTEEM conneCT | ESTEEM conneCT group therapy intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ESTEEM ConneCT | ESTEEM ConneCT group therapy intervention |
| 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 | Depression | To measure depression in participants, the Center for Epidemiological Studies - Depression Scale (CES-D) will be used. An overall depression score is computed as the sum of the 20 items, with Items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums were computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A higher score indicates more depressive symptomatology during the past week. Range is 0 - 60. | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
3 months
Participants' risk for suicide was assessed at baseline, pre-treatment and post-treatment assessments using the Brief Symptom Inventory (Derogatis & Melisaratos, 1983) and Suicidal Ideation Attributes Scale (Spijker et al, 2014).
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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 conneCT | ESTEEM conneCT group therapy intervention | 0 |
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Protocol was amended (April, 2019) and the cohorts did not differ by HIV serostatus. This decision was made: (1) because of the greater number of HIV-negative men, compared to HIV-positive men, who expressed interest in the study and (2) because participants could decide whether to disclose their serostatus in the group, as they do in other real-life interactions with other MSM, as reviewed during the consent process.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Pachankis | Yale University | 6463444060 | 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 | Apr 24, 2019 | Jul 6, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2021 | Jun 3, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2019 | Jul 6, 2021 | ICF_002.pdf |
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Adaptation of the Effective Skills to Empower Effect Men (ESTEEM; Pachankis, 2014; Pachankis et al, 2015) intervention that addresses young gay and bisexual men's occurring maladaptive behavioral patterns, including HIV-transmission risk behavior and mental health concerns, to address multiple stigma-related stressors for young gay and bisexual men of color in a group therapy format. All participants were part of the same intervention (no randomization) to assess the feasibility and acceptability of this adapted intervention (protocol update 4.24.2019; please see attached protocol). Two cohorts were formed to retain ideal group size for group therapy (10-15 participants per group).
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| 3 months |
| Overall Anxiety Severity and Impairment Scale | OASIS (Norman et al., 2006) is a 5-item scale that asks individuals to rate the severity and impairment associated with past-week anxiety symptoms (e.g., "In the past week, when you have felt anxious, how intense or severe was your anxiety?") from 0 (little or none: Anxiety was absent or barely noticeable.) to 4 (extreme: Anxiety was overwhelming. It was impossible to relax at all. Physical symptoms were unbearable). Scores range from 0-20, with higher scores indicating greater anxiety and associated impairment in the past week. | 3 months |
| Brief Symptom Inventory | (BSI; Derogatis & Melisarators, 1983; Meijer et al., 2011). The Global Severity Index of the 18-item 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) in the past 7 days. Scores range from 0-72, with higher scores indicating worse outcomes (greater symptoms severity). | 3 months |
| Suicidal Ideation Attributes Scale | SIDAS (van Spijker et al., 2014) is a 5-item scale that assesses past-month frequency and controllability of suicidal thoughts, how close one has come to making an attempt, and distress and impairment associated with thoughts of suicide (e.g., "In the past month, how often have you had thoughts about suicide?"). Responses range from 0 (never or not at all) to 10 (always or extremely) on each item, with item 2 reverse scored. Scale scores range from 0-50, with higher scores indicating more (worse) suicidal ideation | 3 months |
| Alcohol Use Disorders Identification Test | The AUDIT (Saunders et al.,1993) assesses past-3-month alcohol and related problems across 10 items (e.g., "How often did you have a drink containing alcohol?") with varying numeric response options. A score of 8 or greater serves as a clinical cut-off indicating hazardous drinking. Scores range from 0-40 with higher scores indicating more hazardous drinking (worse outcome) | 3 months |
| Condom-use Self-Efficacy Questionnaire | The SSSEQ assesses respondents' confidence in condom use during sex in different scenarios. Example items include, "How confident are you that you could avoid having anal sex without a condom when you are with someone who is really hot?" and "How confident are you that you could avoid having anal sex without a condom when you are drink or high on drugs?". Response options range from 1 (Not at all confident) to 5 (extremely confident). Scores range from 1 - 65 with higher scores indicating greater self-efficacy around practicing safe sex (better outcome) | 3 months |
| Sexual Compulsivity Scale | The SCS (Kalichman & Rompa, 2011) assesses respondents' compulsivity around sex. Example items include "My desires to have sex have disrupted my daily life" and "My sexual thoughts and behaviors are causing problems in my life", with response options ranging from 1 (Not at all like me) to 4 (Very much like me). Scores range from 1 - 40 with higher scores indicating greater sexual compulsivity (worse outcome) | 3 months |
| Gay-Related Rejection Sensitivity Scale | The GRRS (Pachankis, Goldfried & Ramrattan, 2008) asks respondents to rate 14 vignettes in terms of how concerned or anxious each would make them about being rejected because of their sexual orientation, and their likelihood of attributing the rejection to their sexual orientation. For example, one item states, "You've been dating someone for a few years now and you receive a wedding invitation to a straight friend's wedding. The invite was addressed only to you, not you and a guest". Responses to the anxiety and likelihood stems range from 1 (very unconcerned/very unlikely) to 6 (very concerned/very likely). Total score is the sum of the products of anxiety and likelihood scores of all items and ranges from 0-504 with higher scores indicating greater rejection sensitivity (worse outcome). | 3 months |
| Self-concealment Scale | The SCS (Larson & Chastain, 1990; Schrimshaw, Siegel, Downing & Parsons, 2013) assesses the respondents' concealment of their sexual orientation. Example items include, "I haven't shared with anyone that I have sex with men" and "When I have sex with men, I keep it to myself". Response options range from 1 (strongly disagree) to 5 (strongly agree). Scale scores range from 7-35 with higher scores indicating greater concealment of one's sexual orientation. | 3 months |
| Internalized Homophobia Scale | The IHS assesses internalized stigma related to respondents' sexual orientation, asking them to rate thoughts and feelings related to their LGBTQ identity (e.g., "You have wished you weren't gay, bisexual, or queer). Responses range from 1 (never) to 4 (often). Scale scores range from 9 - 36 with higher scores indicating greater internalized stigma (worse outcome). | 3 months |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Sexual Orientation | Count of Participants | Participants |
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| HIV Status | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
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| Education level | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | HIV Transmission Risk | Risk of HIV transmission was assessed through the Past-90-day Timeline Follow-back interview (TLFB; Sobell & Sobell, 1992). HIV risk behavior was calculated as the number of past-90-day sex acts in which key harm-reduction strategies were not employed (e.g., condom, PrEP, viral load suppression) and calculated by dividing the total number of sex acts at risk for HIV transmission by the total number of sex acts. Sex acts range from 0 to (theoretically) infinite. | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | Number of sex acts conferring HIV risk | 90 days |
|
|
|
| Secondary | Overall Depression Severity and Impairment Scale | ODSIS (Bentley et al., 2014) is a 5-item scale that asks individuals to rate the severity and impairment associated with past-week symptoms of depression (e.g., "In the past week, when you have felt depressed, how intense or severe was your depression?) from 0 (little or none: Depression was absent or barely noticeable.) to 4 (extreme: Depression was overwhelming.). Scores range from 0-20, with higher scores indicating greater depression and associated impairment in the past week. | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Overall Anxiety Severity and Impairment Scale | OASIS (Norman et al., 2006) is a 5-item scale that asks individuals to rate the severity and impairment associated with past-week anxiety symptoms (e.g., "In the past week, when you have felt anxious, how intense or severe was your anxiety?") from 0 (little or none: Anxiety was absent or barely noticeable.) to 4 (extreme: Anxiety was overwhelming. It was impossible to relax at all. Physical symptoms were unbearable). Scores range from 0-20, with higher scores indicating greater anxiety and associated impairment in the past week. | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Brief Symptom Inventory | (BSI; Derogatis & Melisarators, 1983; Meijer et al., 2011). The Global Severity Index of the 18-item 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) in the past 7 days. Scores range from 0-72, with higher scores indicating worse outcomes (greater symptoms severity). | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Suicidal Ideation Attributes Scale | SIDAS (van Spijker et al., 2014) is a 5-item scale that assesses past-month frequency and controllability of suicidal thoughts, how close one has come to making an attempt, and distress and impairment associated with thoughts of suicide (e.g., "In the past month, how often have you had thoughts about suicide?"). Responses range from 0 (never or not at all) to 10 (always or extremely) on each item, with item 2 reverse scored. Scale scores range from 0-50, with higher scores indicating more (worse) suicidal ideation | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Alcohol Use Disorders Identification Test | The AUDIT (Saunders et al.,1993) assesses past-3-month alcohol and related problems across 10 items (e.g., "How often did you have a drink containing alcohol?") with varying numeric response options. A score of 8 or greater serves as a clinical cut-off indicating hazardous drinking. Scores range from 0-40 with higher scores indicating more hazardous drinking (worse outcome) | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Condom-use Self-Efficacy Questionnaire | The SSSEQ assesses respondents' confidence in condom use during sex in different scenarios. Example items include, "How confident are you that you could avoid having anal sex without a condom when you are with someone who is really hot?" and "How confident are you that you could avoid having anal sex without a condom when you are drink or high on drugs?". Response options range from 1 (Not at all confident) to 5 (extremely confident). Scores range from 1 - 65 with higher scores indicating greater self-efficacy around practicing safe sex (better outcome) | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Sexual Compulsivity Scale | The SCS (Kalichman & Rompa, 2011) assesses respondents' compulsivity around sex. Example items include "My desires to have sex have disrupted my daily life" and "My sexual thoughts and behaviors are causing problems in my life", with response options ranging from 1 (Not at all like me) to 4 (Very much like me). Scores range from 1 - 40 with higher scores indicating greater sexual compulsivity (worse outcome) | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Gay-Related Rejection Sensitivity Scale | The GRRS (Pachankis, Goldfried & Ramrattan, 2008) asks respondents to rate 14 vignettes in terms of how concerned or anxious each would make them about being rejected because of their sexual orientation, and their likelihood of attributing the rejection to their sexual orientation. For example, one item states, "You've been dating someone for a few years now and you receive a wedding invitation to a straight friend's wedding. The invite was addressed only to you, not you and a guest". Responses to the anxiety and likelihood stems range from 1 (very unconcerned/very unlikely) to 6 (very concerned/very likely). Total score is the sum of the products of anxiety and likelihood scores of all items and ranges from 0-504 with higher scores indicating greater rejection sensitivity (worse outcome). | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Self-concealment Scale | The SCS (Larson & Chastain, 1990; Schrimshaw, Siegel, Downing & Parsons, 2013) assesses the respondents' concealment of their sexual orientation. Example items include, "I haven't shared with anyone that I have sex with men" and "When I have sex with men, I keep it to myself". Response options range from 1 (strongly disagree) to 5 (strongly agree). Scale scores range from 7-35 with higher scores indicating greater concealment of one's sexual orientation. | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Internalized Homophobia Scale | The IHS assesses internalized stigma related to respondents' sexual orientation, asking them to rate thoughts and feelings related to their LGBTQ identity (e.g., "You have wished you weren't gay, bisexual, or queer). Responses range from 1 (never) to 4 (often). Scale scores range from 9 - 36 with higher scores indicating greater internalized stigma (worse outcome). | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
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| Other Pre-specified | PrEP Use | Participants indicated whether they had been adherent to PrEP in the past three months. | Analysis population for 3-month follow-up (n = 17) due to drop out. | Posted | Count of Participants | Participants | 3 months |
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| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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