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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432819
• Other study ID #: R34MH113413
• Status: Completed
• Phase: N/A
• Start date: March 27, 2018
• Est. completion date: September 16, 2019

Study information

• Verified date: March 2023
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 16, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• HIV Seropositivity

Intervention

Behavioral:
• Siempre Seguiré
A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care.

Locations

Country	Name	City	State
United States	Bienestar Human Services, Inc.	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
RAND	Bienestar Human Services, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Adherence (MEMS)	Percentage of doses taken, of those prescribed, from electronic monitoring	4-5 and 6-7 months post-baseline
Primary	Continuous Adherence (Self-report)	Percentage of doses taken, of those prescribed, self-report	4 and 7 months post-baseline
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	4 and 7 months post-baseline
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	4 and 7 months post-baseline
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	4 and 7 months post-baseline
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	4 and 7 months post-baseline
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.	4 and 7 months post-baseline
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.	4 and 7 months post-baseline
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.	4 and 7 months post-baseline
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.	4 and 7 months post-baseline