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| Name | Class |
|---|---|
| Bienestar Human Services, Inc. | OTHER |
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R34-funded study to pilot test an intervention to improve coping with discrimination and adherence among Latino men who have sex with men (MSM) living with HIV. The proposed research aims to modify and refine Siempre Seguiré, a culturally congruent cognitive behavior therapy group intervention for HIV-positive Latino men who have sex with men (LMSM), to include strategies for ART adherence and retention in HIV care; and to conduct a small randomized pilot of Siempre Seguiré to examine feasibility and acceptability, as well as to explore preliminary effects on coping responses to discrimination and antiretroviral treatment adherence among LMSM living with HIV.
HIV-related disparities in diagnosis and disease outcomes persist among Latinos, and Latinos living with HIV show a lower percentage of viral suppression compared to the general HIV-positive population. A growing body of work suggests that stigma and discrimination contribute to health disparities, especially among people living with HIV, who may experience discrimination due to multiple stigmatized identities related to HIV-serostatus, race/ethnicity, and sexual orientation. Internalized stigma and discrimination may lead to health-related disparities by increasing detrimental physiological stress responses, resulting in maladaptive coping and poor health behaviors, including non-adherence to treatment. Moreover, the chronic stress of discrimination may weaken immune function, leading to worse HIV outcomes, including increased HIV viral load. The proposed research will integrate adherence skills-building strategies into a recently developed intervention, Siempre Seguiré, an 8-session group cognitive behavioral therapy (CBT) intervention for HIV-positive Latino men who have sex with men (LMSM) that aims to improve adaptive coping responses to discrimination. The specific aims are: (1) To modify and refine Siempre Seguiré, a newly developed culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for antiretroviral treatment adherence and retention in HIV care; and (2) To conduct a small randomized pilot of Siempre Seguiré to examine feasibility and acceptability, as well as to explore preliminary effects on: (a) coping responses to discrimination; and (b) antiretroviral treatment adherence, viral load suppression, and HIV care retention, among LMSM living with HIV. In Phase 1, HIV treatment adherence intervention experts and key stakeholders, including a community advisory board, will help to refine our pilot intervention as needed and update our manual to integrate information and skills building regarding HIV treatment adherence and retention in care. In Phase 2, a small randomized controlled trial of 80 participants (40 intervention participants divided evenly over 4 intervention groups vs. 40 wait-list control participants) will be conducted. Participants will complete surveys at baseline, and 4- and 6-months post-baseline to assess coping and HIV care processes and outcomes. Adherence will be electronically monitored, and viral load will be collected from medical providers at baseline and at 6-month follow-up. Intervention group sessions will take place once per week for 8 weeks. Sessions will take place in a private room at Bienestar (a Latino-serving AIDS service organization in LAC) and will last approximately 90 minutes. We hypothesize that the intervention will improve coping responses to discrimination and HIV treatment adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Siempre Seguiré | Experimental | We will conduct a small randomized controlled trial (RCT), testing study protocols and materials, the acceptability of randomization, and overall program feasibility. The pilot will help to identify logistical considerations; assess whether the program is acceptable and understandable LMSM; and collect initial data on how successfully the program motivates change in coping and adherence. It will allow us to estimate expected attrition and response rates, and to perform preliminary power analyses in preparation for a fully powered RCT. |
|
| Control | No Intervention | Control participants will not be randomized to receive the intervention and will receive standard of care during the intervention period. We will offer the program to any interested control participants shortly after the 6-month follow-up surveys are completed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siempre Seguiré | Behavioral | A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Adherence (MEMS) | Percentage of doses taken, of those prescribed, from electronic monitoring | 4-5 and 6-7 months post-baseline |
| Continuous Adherence (Self-report) | Percentage of doses taken, of those prescribed, self-report | 4 and 7 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Coping Strategies | Functional coping strategies as measured by 16 Brief COPE items on active coping, acceptance, social support, positive reframing, planning, humor, and religion, and three additional functional coping items based on prior qualitative research on coping in communities of color ("I tell myself that other people are ignorant"; "I avoid certain situations or people so that I am not discriminated against in the future"; and "I change the way that I dress or talk so that I am not discriminated against in the future"). Responses were 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 in response to discrimination |
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Inclusion Criteria:
Exclusion Criteria:
Biologically male at birth and continue to identify as male
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37392342 | Derived | Barreras JL, Bogart LM, MacCarthy S, Klein DJ, Pantalone DW. Discrimination and adherence in a cross-sectional study of Latino sexual minority men with HIV: Coping with discrimination as a mediator and coping self-efficacy as a moderator. J Behav Med. 2023 Dec;46(6):1057-1067. doi: 10.1007/s10865-023-00426-6. Epub 2023 Jul 1. | |
| 33231847 | Derived | Bogart LM, Barreras JL, Gonzalez A, Klein DJ, Marsh T, Agniel D, Pantalone DW. Pilot Randomized Controlled Trial of an Intervention to Improve Coping with Intersectional Stigma and Medication Adherence Among HIV-Positive Latinx Sexual Minority Men. AIDS Behav. 2021 Jun;25(6):1647-1660. doi: 10.1007/s10461-020-03081-z. Epub 2020 Nov 24. |
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Between completing the baseline survey and being randomized 5 participants were lost to follow up and 1 withdrew due to issues related to homelessness.
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| ID | Title | Description |
|---|---|---|
| FG000 | Siempre Seguiré | We will conduct a small RCT, testing study protocols and materials, the acceptability of randomization, and overall program feasibility. The pilot will help to identify logistical considerations; assess whether the program is acceptable and understandable LMSM; and collect initial data on how successfully the program motivates change in coping and adherence. It will allow us to estimate expected attrition and response rates, and to perform preliminary power analyses in preparation for a fully powered RCT. Siempre Seguiré: A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care. |
| FG001 | Control | Control participants will not be randomized to receive the intervention and will receive standard of care during the intervention period. We will offer the program to any interested control participants shortly after the 6-month follow-up surveys are completed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Siempre Seguiré | We will conduct a small RCT, testing study protocols and materials, the acceptability of randomization, and overall program feasibility. The pilot will help to identify logistical considerations; assess whether the program is acceptable and understandable LMSM; and collect initial data on how successfully the program motivates change in coping and adherence. It will allow us to estimate expected attrition and response rates, and to perform preliminary power analyses in preparation for a fully powered RCT. Siempre Seguiré: A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care. |
| 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 | Continuous Adherence (MEMS) | Percentage of doses taken, of those prescribed, from electronic monitoring | Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. | Posted | Mean | Standard Deviation | % of doses taken, past month | 4-5 and 6-7 months post-baseline |
|
7 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 | Siempre Seguiré | We will conduct a small RCT, testing study protocols and materials, the acceptability of randomization, and overall program feasibility. The pilot will help to identify logistical considerations; assess whether the program is acceptable and understandable LMSM; and collect initial data on how successfully the program motivates change in coping and adherence. It will allow us to estimate expected attrition and response rates, and to perform preliminary power analyses in preparation for a fully powered RCT. Siempre Seguiré: A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Bogart, PhD | RAND Corporation | (310) 393-0411 | 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 | Feb 1, 2019 | Nov 18, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| 4 and 7 months post-baseline |
| Positive Religious Coping Strategies | Positive religious coping strategies as measured by an R-COPE sub-scale to assess secure relationships with a divine force/spiritual connectedness. Responses were 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 in response to discrimination | 4 and 7 months post-baseline |
| Dysfunctional Coping Strategies | Dysfunctional/ineffective coping strategies dysfunctional/ineffective as measured by 12 Brief COPE items on denial, substance use, behavioral disengagement, venting, self-blame, and self-distraction. Responses were 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 in response to discrimination | 4 and 7 months post-baseline |
| Negative Religious Coping Strategies | Negative religious coping strategies as measured by an R-COPE sub-scale to assess underlying spiritual tensions/internal struggles. Responses were 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 in response to discrimination | 4 and 7 months post-baseline |
| Medical Mistrust (General) | General medical mistrust was measured with the Mistrust of Healthcare Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. | 4 and 7 months post-baseline |
| Medical Mistrust (HIV Conspiracy Beliefs) | HIV-specific medical mistrust was measured with the HIV Conspiracy Beliefs Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. | 4 and 7 months post-baseline |
| Internalized Stigma (Sexual Orientation) | Internalized sexual minority stigma was assessed with the Internalized-Homophobia Scale-Revised. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. | 4 and 7 months post-baseline |
| Internalized Stigma (HIV) | Internalized HIV stigma was assessed with the Internalized AIDS-Related Stigma Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. | 4 and 7 months post-baseline |
| BG001 | Control | Control participants will not be randomized to receive the intervention and will receive standard of care during the intervention period. We will offer the program to any interested control participants shortly after the 6-month follow-up surveys are completed. |
| BG002 | Total | Total of all reporting groups |
| years |
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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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| ART Adherence | The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%). | Mean | Standard Deviation | % of doses taken, past month |
|
| Coping with discrimination | We adapted Brief COPE and R-COPE and asked participants how much they responded in a certain way when faced with discrimination. Responses were 1 = I haven't been doing this at all to 4 = I've been doing this a lot. Functional coping included 16 Brief COPE items, e.g., active coping, and three additional items, e.g., avoid certain situations. Dysfunctional coping included 12 Brief COPE items, e.g., denial. Two R-COPE sub scales were created to assess positive religious coping, e.g., secure relationships with a divine force, and negative religious coping, e.g., underlying spiritual tensions. | The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%). | Mean | Standard Deviation | units on a scale |
|
| Medical mistrust | General medical mistrust was measured with the Mistrust of Healthcare Scale. HIV-specific medical mistrust was measured with the HIV Conspiracy Beliefs Scale. Response options for both were: 1 = Strongly Disagree to 5 = Strongly Agree. | The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%). | Mean | Standard Deviation | units on a scale |
|
| Internalized stigma (HIV) | Internalized HIV stigma was assessed with the Internalized AIDS-Related Stigma Scale . Internalized sexual minority stigma was assessed with the Internalized-Homophobia Scale-Revised. Response options for both were 1 = Strongly Disagree to 5 = Strongly Agree. | The baseline analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. Of the 76 participants who completed a baseline survey and were randomized, 63 (98.4%) responded to both follow-ups, another 2 responded only to the 4-month FUP, and another 1 responded only to the 7-month FUP, for a total of 66 who responded to at least one FUP (86.8%). | Mean | Standard Deviation | units on a scale |
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| OG001 | Control | Control participants will not be randomized to receive the intervention and will receive standard of care during the intervention period. We will offer the program to any interested control participants shortly after the 6-month follow-up surveys are completed. |
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| Primary | Continuous Adherence (Self-report) | Percentage of doses taken, of those prescribed, self-report | Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. | Posted | Mean | Standard Deviation | % of doses taken, past month | 4 and 7 months post-baseline |
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| Secondary | Functional Coping Strategies | Functional coping strategies as measured by 16 Brief COPE items on active coping, acceptance, social support, positive reframing, planning, humor, and religion, and three additional functional coping items based on prior qualitative research on coping in communities of color ("I tell myself that other people are ignorant"; "I avoid certain situations or people so that I am not discriminated against in the future"; and "I change the way that I dress or talk so that I am not discriminated against in the future"). Responses were 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 in response to discrimination | Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | 4 and 7 months post-baseline |
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| Secondary | Positive Religious Coping Strategies | Positive religious coping strategies as measured by an R-COPE sub-scale to assess secure relationships with a divine force/spiritual connectedness. Responses were 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 in response to discrimination | Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | 4 and 7 months post-baseline |
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| Secondary | Dysfunctional Coping Strategies | Dysfunctional/ineffective coping strategies dysfunctional/ineffective as measured by 12 Brief COPE items on denial, substance use, behavioral disengagement, venting, self-blame, and self-distraction. Responses were 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 in response to discrimination | Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | 4 and 7 months post-baseline |
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| Secondary | Negative Religious Coping Strategies | Negative religious coping strategies as measured by an R-COPE sub-scale to assess underlying spiritual tensions/internal struggles. Responses were 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 in response to discrimination | Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | 4 and 7 months post-baseline |
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| Secondary | Medical Mistrust (General) | General medical mistrust was measured with the Mistrust of Healthcare Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. | Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | 4 and 7 months post-baseline |
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| Secondary | Medical Mistrust (HIV Conspiracy Beliefs) | HIV-specific medical mistrust was measured with the HIV Conspiracy Beliefs Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. | Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | 4 and 7 months post-baseline |
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| Secondary | Internalized Stigma (Sexual Orientation) | Internalized sexual minority stigma was assessed with the Internalized-Homophobia Scale-Revised. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. | Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | 4 and 7 months post-baseline |
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| Secondary | Internalized Stigma (HIV) | Internalized HIV stigma was assessed with the Internalized AIDS-Related Stigma Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree. | Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | 4 and 7 months post-baseline |
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| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Control | Control participants will not be randomized to receive the intervention and will receive standard of care during the intervention period. We will offer the program to any interested control participants shortly after the 6-month follow-up surveys are completed. | 0 | 38 | 0 | 38 | 0 | 38 |
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| Unknown or Not Reported |
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