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Government executive order
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| Name | Class |
|---|---|
| Bienestar Human Services, Inc. | OTHER |
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This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP use among Latinx sexual minority men (SMM).
This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP use among Latinx sexual minority men (SMM). We will test intervention effects on regular HIV testing and use of prevention strategies. The intervention was developed in partnership with community stakeholders at Bienestar Human Services, Inc., a Latinx-focused organization in Los Angeles County (LAC), CA. The intervention is flexible for use in community-based organizations, such as in ongoing support groups.
The Specific Aims are:
Aim 1. To conduct a randomized controlled trial of a culturally congruent cognitive behavior therapy group intervention for immigrant Latinx sexual minority men, to test intervention effects on regular HIV testing and PrEP uptake.
Aim 2. To examine mechanisms of intervention effects on regular HIV testing and PrEP uptake, including more effective coping (e.g., reduced internalized stigma).
Aim 3. To conduct a cost-effectiveness analysis of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT Coping Intervention | Experimental | The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM). |
|
| Control | No Intervention | Participants who are randomized to the control condition will be referred to the standard of care program at Bienestar, which includes an ongoing weekly open wellness-oriented support group available to all clients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT Coping Intervention | Behavioral | A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Test at Least Annually | Participants report being tested for HIV at least once in the 12 months after baseline | from baseline to 12-months |
| Took PrEP in the Past 12 Months | Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period) | from baseline to 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Adaptive Coping | Participants completed the Brief COPE, a general measure of coping strategies. Items have the instruction "indicate the extent you do what the item says when you are faced with discrimination," and response options 1 = "I haven't been doing this at all," 2 = "I've been doing this a little bit," 3 = "I've been doing this a medium amount" and 4 = "I've been doing this a lot." This scale (identified by EFA) is the mean of 4 items such as "I get emotional support from others". Higher values indicate more use of these coping strategies. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Bogart, PhD | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bienestar Human Services, Inc | Los Angeles | California | 90022 | United States |
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Of 607 screened, 455 met inclusion criteria, of whom 289 were randomized.
Participants were recruited across Southern California using: in-person in-reach at the partner organization; in-person outreach at relevant events and businesses; passive recruitment via hard copy fliers left at the partner community-based organization and other relevant local organizations; social media recruitment via paid advertisements, video posts, and direct messaging. Participants also were offered $10 per referral, for up to three referrals.
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT Coping Intervention | The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM). CBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies. |
| FG001 | Control | Participants who are randomized to the control condition will receive standard of care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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9 withdrawn (3 control, 6 intervention); 41 no follow-up data (5 control, 36 intervention) Analysis sample = 136 control, 103 intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT Coping Intervention | The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM). CBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies. |
| 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 | HIV Test at Least Annually | Participants report being tested for HIV at least once in the 12 months after baseline | Posted | Count of Participants | Participants | from baseline to 12-months |
|
3 years, 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBT Coping Intervention | The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM). CBT Coping Intervention: A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Potential confidentiality breach | Social circumstances | Non-systematic Assessment |
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Objective HIV testing dates and PrEP prescription data were collected (e.g., from medical records), but the US federal government (NIH) terminated the grant prematurely on March 20, 2025 before these data could be processed. These data were not fully cleaned or tabulated, and thus were not analyzed as an outcome and cannot be entered at baseline: The number of records is unknown and therefore not reported here. Thus, the primary outcomes are reported based on self-reported survey responses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Bogart, PhD | RAND | 3103830411 | 7281 | lbogart@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2020 | Jan 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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Outcomes assessor does not randomize participant until after the baseline assessment
| measured at 4-months, 8-months, and 12-months post baseline |
| BG001 | Control | Participants who are randomized to the control condition will be referred to the standard of care program at Bienestar, which includes an ongoing weekly open wellness-oriented support group available to all clients. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HIV testing in past 12 months | Data missing for n=7 participants who did not answer whether they had ever had an HIV test or who did not provide the date of their last test | Count of Participants | Participants |
|
| Current PrEP use | Count of Participants | Participants |
|
| Brief COPE: Social support-seeking | Participants completed the Brief COPE, a general measure of coping strategies. Items have the instruction "indicate the extent you do what the item says when you are faced with discrimination," and response options 1 = "I haven't been doing this at all," 2 = "I've been doing this a little bit," 3 = "I've been doing this a medium amount" and 4 = "I've been doing this a lot." This scale (identified by EFA) is the mean of 4 items such as "I get emotional support from others". Cronbach's alpha = .79. Higher values indicate more use of these coping strategies. | Coping missing for n=2 who did not respond to any of the 4 survey items in the scale | Mean | Standard Deviation | scores on a scale |
|
| OG001 | Control | Participants who are randomized to the control condition will receive standard of care |
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| Primary | Took PrEP in the Past 12 Months | Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period) | Of the N=289 described in Baseline Characteristics, N=50 did not complete any follow up assessments. Outcome measures are assessed for the remaining N=239 | Posted | Count of Participants | Participants | from baseline to 12-months |
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| Secondary | Level of Adaptive Coping | Participants completed the Brief COPE, a general measure of coping strategies. Items have the instruction "indicate the extent you do what the item says when you are faced with discrimination," and response options 1 = "I haven't been doing this at all," 2 = "I've been doing this a little bit," 3 = "I've been doing this a medium amount" and 4 = "I've been doing this a lot." This scale (identified by EFA) is the mean of 4 items such as "I get emotional support from others". Higher values indicate more use of these coping strategies. | Of the N=289 described in Baseline Characteristics, N=50 did not complete any follow up assessments. An additional N=2 control participants did not respond to any of the 4 items in the scale, leaving N=237 for analysis | Posted | Mean | Standard Deviation | scores on a scale | measured at 4-months, 8-months, and 12-months post baseline |
|
|
|
|
| 0 |
| 145 |
| 21 |
| 145 |
| 0 |
| 145 |
| EG001 | Control | Participants who are randomized to the control condition will receive standard of care | 0 | 144 | 3 | 144 | 0 | 144 |
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| social threat/violence | Social circumstances | Non-systematic Assessment |
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| Surgery due to pre-existing condition | Surgical and medical procedures | Non-systematic Assessment |
|
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 8-month assessment |
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| 12-month assessment |
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Slope is adjusted regression coefficient for indicator of intervention arm
| Superiority |