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A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM

Primary Purpose

HIV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Siempre Seguiré
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring Latino, men who have sex with men

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 years-old or older, HIV-positive, biologically male at birth and continue to identify as male, identify as Latino, report having sex with men in the past 12 months, and prescribed ART.

Exclusion Criteria:

  • Being unwilling or unable to provide informed consent; having mental health problems that require immediate treatment (e.g., psychotic symptoms) or a diagnosed mental disorder that would limit ability to participate (e.g., dementia); and cognitive impairments that result in limited ability to provide informed consent.

Sites / Locations

  • Bienestar Human Services, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Siempre Seguiré

Control

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Continuous Adherence (MEMS)
Percentage of doses taken, of those prescribed, from electronic monitoring
Continuous Adherence (Self-report)
Percentage of doses taken, of those prescribed, self-report

Secondary Outcome Measures

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
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
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
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
Medical Mistrust (General)
General medical mistrust was measured with the Mistrust of Healthcare Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
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.
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.
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.

Full Information

First Posted
January 31, 2018
Last Updated
March 27, 2023
Sponsor
RAND
Collaborators
Bienestar Human Services, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03432819
Brief Title
A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM
Official Title
A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
September 12, 2019 (Actual)
Study Completion Date
September 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
Bienestar Human Services, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
Latino, men who have sex with men

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Siempre Seguiré
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Siempre Seguiré
Intervention Description
A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care.
Primary Outcome Measure Information:
Title
Continuous Adherence (MEMS)
Description
Percentage of doses taken, of those prescribed, from electronic monitoring
Time Frame
4-5 and 6-7 months post-baseline
Title
Continuous Adherence (Self-report)
Description
Percentage of doses taken, of those prescribed, self-report
Time Frame
4 and 7 months post-baseline
Secondary Outcome Measure Information:
Title
Functional Coping Strategies
Description
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
Time Frame
4 and 7 months post-baseline
Title
Positive Religious Coping Strategies
Description
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
Time Frame
4 and 7 months post-baseline
Title
Dysfunctional Coping Strategies
Description
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
Time Frame
4 and 7 months post-baseline
Title
Negative Religious Coping Strategies
Description
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
Time Frame
4 and 7 months post-baseline
Title
Medical Mistrust (General)
Description
General medical mistrust was measured with the Mistrust of Healthcare Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Time Frame
4 and 7 months post-baseline
Title
Medical Mistrust (HIV Conspiracy Beliefs)
Description
HIV-specific medical mistrust was measured with the HIV Conspiracy Beliefs Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Time Frame
4 and 7 months post-baseline
Title
Internalized Stigma (Sexual Orientation)
Description
Internalized sexual minority stigma was assessed with the Internalized-Homophobia Scale-Revised. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Time Frame
4 and 7 months post-baseline
Title
Internalized Stigma (HIV)
Description
Internalized HIV stigma was assessed with the Internalized AIDS-Related Stigma Scale. Response options were 1 = Strongly Disagree to 5 = Strongly Agree.
Time Frame
4 and 7 months post-baseline

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Biologically male at birth and continue to identify as male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 years-old or older, HIV-positive, biologically male at birth and continue to identify as male, identify as Latino, report having sex with men in the past 12 months, and prescribed ART. Exclusion Criteria: Being unwilling or unable to provide informed consent; having mental health problems that require immediate treatment (e.g., psychotic symptoms) or a diagnosed mental disorder that would limit ability to participate (e.g., dementia); and cognitive impairments that result in limited ability to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Bogart, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bienestar Human Services, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33231847
Citation
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.
Results Reference
derived

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A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM

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