Clinical Trials

MainTitle

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

This study is ongoing, but not recruiting participants.
Sponsor
RAND

Collaborator
Bienestar Human Services, Inc.

Information provided by (Responsible Party)
RAND
ClinicalTrials.gov Identifier
NCT03432819

First received: January 31, 2018
Last updated: April 17, 2020
Last Verified: April 2020
History of Changes
Purpose

Purpose

R34-funded study to pilot test an intervention to improve coping with discrimination and adherence among Latino 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 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.

Condition Intervention
HIV

Behavioral : Siempre Seguiré

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM

Further study details as provided by RAND:

Primary Outcome Measures

  • Change in adaptive coping strategies [ Time Frame: Change from baseline to 4 and 6 months post-baseline ]
    Increase in adaptive coping strategies
  • Change in maladaptive coping strategies [ Time Frame: Change from baseline to 4 and 6 months post-baseline ]
    Decrease in maladaptive coping
Secondary Outcome Measures:
  • Change in Continuous Adherence [ Time Frame: Change from baseline to 4 and 6 months post-baseline ]
    Percentage of doses taken, of those prescribed, from electronic monitoring
  • Change in continuous adherence [ Time Frame: change from baseline to 4 and 6 months post-baseline ]
    Percentage of doses taken, of those prescribed, self-report

Enrollment: 82
Study Start Date: March 26, 2018
Estimated Study Completion Date: August 31, 2020
Estimated Primary Completion Date: August 31, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 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.
Behavioral: Siempre Seguiré

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

No Intervention: 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.

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03432819

Locations

United States, California
Bienestar Human Services, Inc.
Los Angeles, California, United States, 90022

Sponsors and Collaborators

RAND
Bienestar Human Services, Inc.

Investigators

Principal Investigator: Laura Bogart, PhD RAND
More Information

More Information


Responsible Party: RAND  
ClinicalTrials.gov Identifier: NCT03432819   History of Changes  
Other Study ID Numbers: R34MH113413  
Study First Received: January 31, 2018  
Last Updated: April 17, 2020  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by RAND:

Latino, men who have sex with men

Additional relevant MeSH terms:
HIV Seropositivity

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.