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

NCT03432819 | Completed Results

• 1 other identifier: R34MH113413
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Latino, men who have sex with men

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Functional Coping Strategies

  4 and 7 months post-baseline

• Positive Religious Coping Strategies

  4 and 7 months post-baseline

• Dysfunctional Coping Strategies

  4 and 7 months post-baseline

• Negative Religious Coping Strategies

  4 and 7 months post-baseline

• Medical Mistrust (General)

  4 and 7 months post-baseline

Study Arms (2)

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.

Behavioral: Siempre Seguiré

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.

Interventions

Siempre Seguiré BEHAVIORAL

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

Siempre Seguiré

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biologically male at birth and continue to identify as male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RAND: lead
• Bienestar Human Services, Inc.: collaborator

Study Sites (1)

Bienestar Human Services, Inc.

Los Angeles, California, 90022, United States

Location

Related Publications (2)

• 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.

  PMID: 37392342 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.

  PMID: 33231847 DERIVED

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Results Point of Contact

• Title: Laura Bogart, PhD
• Organization: RAND Corporation

lbogart@rand.org

(310) 393-0411

Study Officials

• Laura Bogart, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 14, 2018
• Study Start: March 27, 2018
• Primary Completion: September 12, 2019
• Study Completion: September 16, 2019
• Last Updated: March 29, 2023
• Results First Posted: February 25, 2021

Record last verified: 2023-03

Locations

US (1)