Cross-disciplinary HIV Integrated Mental Health Support Intervention (CHIMES)

November 12, 2025 updated by: Sophia Hussen, Emory University

Cross-disciplinary HIV Integrated Mental Health Support (CHIMES) Intervention

The proposed project seeks to develop and test an intervention to improve engagement in HIV and mental health care for young Black gay, bisexual and other men who have sex with men (YB-GBMSM) in Ryan White clinics.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Young Black gay, bisexual and other men who have sex with men (YB-GBMSM) are disproportionately impacted by HIV, with suboptimal rates of engagement across the HIV Continuum of Care (HIV-CoC). Mental health (MH) comorbidities contribute to poor HIV care engagement for many YB-GBMSM; however, effective treatment for these conditions is hindered by barriers including logistical challenges, medical mistrust, and MH stigma.

The Ryan White Care act supports integration of HIV and MH services; however, preliminary studies demonstrate low rates of MH referrals and MH care engagement among YB-GBMSM living with HIV, even in these ostensibly integrated care settings. The objective of this study is to develop and implement CHIMES (Cross-disciplinary HIV Integrated with Mental Health Support), a clinic- and provider-level intervention to improve HIV-MH care integration and MH care engagement among YB-GBMSM attending Ryan White clinics.

The rationale for this study is that efforts to improve integration of services, particularly if they are culturally tailored, are likely to increase MH and HIV care engagement for YB-GBMSM. The proposed study will pursue two specific aims: (1) to develop the CHIMES intervention; and (2) to conduct a hybrid type 2 implementation-effectiveness pilot trial of CHIMES in two Health Resources and Services Administration (HRSA)/Ryan White-funded clinics in Atlanta, Georgia - a city in the heart of the Southern HIV epidemic.

For the first aim, the researchers will work collaboratively with provider and patient stakeholders, adapt existing evidence-based interventions, and build on formative data to refine intervention content, informed by the Capability- Opportunity-Motivation-Behavior (COM-B) Model. For the second aim, the researchers will implement CHIMES in the two clinic settings and conduct a mixed-methods assessment in which continuous data collection informed by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework will be used to evaluate effectiveness and implementation processes.

The effectiveness of the CHIMES intervention will be measured by change in HIV and MH care engagement before, during, and after CHIMES implementation. The researchers will abstract clinic-level aggregate data to characterize change in HIV-CoC and MH care engagement outcomes for YB-GBMSM.

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Grady Infectious Diseases Clinic (Ponce Clinic)
      • Atlanta, Georgia, United States, 30322
        • Emory Midtown Hospital Infectious Disease Outpatient Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • young Black gay, bisexual and other men who have sex with men (YB-GBMSM) living with HIV
  • patient at Grady Health System Infectious Disease Program or Emory University Hospital Midtown Infectious Disease Clinic

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clinic Patients During the Pre-implementation Period
Patients visiting one of the study clinics prior to implementation of the CHIMES intervention. The Baseline time period consists of study Months 1 - 12. Data are retroactively abstracted from medical records of patients who had clinic visits that occurred between January 1, 2019 and December 31, 2019.
Behavioral: Standard of Care
The standard of care practices of referring patients to mental health services of the clinic during Months 1 - 12 of the study.
Experimental: Clinic Patients During the Implementation Period
Patients visiting one of the study clinics during the Implementation period of the CHIMES intervention. Data will be abstracted from medical records of visits that occur during study Months 13 - 27.
Behavioral: CHIMES Intervention

There are six components to the intervention:

  1. Posters and other print materials to prompt providers and patients to discuss MH care engagement.
  2. Brief verbal scripts to help HIV providers facilitate patient MH engagement and discuss barriers to MH utilization.
  3. Expanded MH screening procedures, including at initial intake.
  4. Case management, emphasizing MH care engagement.
  5. Interactive trainings for all HIV providers on MH needs, screening/treatment, and barriers to MH service utilization specific to YB-GBMSM.
  6. Regular case review meetings.
Experimental: Clinic Patients During the Maintenance Period
Patients visiting one of the study clinics during the Maintenance period of the CHIMES intervention. Data will be abstracted from medical records of visits that occur during study Months 28 - 33.
Behavioral: CHIMES Intervention

There are six components to the intervention:

  1. Posters and other print materials to prompt providers and patients to discuss MH care engagement.
  2. Brief verbal scripts to help HIV providers facilitate patient MH engagement and discuss barriers to MH utilization.
  3. Expanded MH screening procedures, including at initial intake.
  4. Case management, emphasizing MH care engagement.
  5. Interactive trainings for all HIV providers on MH needs, screening/treatment, and barriers to MH service utilization specific to YB-GBMSM.
  6. Regular case review meetings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Mental Health Visits
Time Frame: Baseline (Months 1-12) up to Month 33
The number of mental health visits by clinic patients during each study time period.
Baseline (Months 1-12) up to Month 33
Percentage of Mental Health Visits by YB-GBMSM
Time Frame: Baseline (Months 1-12) up to Month 33
The percentage of mental health visits by YB-GBMSM clinic patients during each study time period.
Baseline (Months 1-12) up to Month 33
Number of Patients Attending Two HIV Care Visits
Time Frame: Baseline (Months 1-12) up to Month 33
The number of patients who come to two HIV Care visits in a 12 month period, during each study time period.
Baseline (Months 1-12) up to Month 33
Number of Patients with HIV RNA Viral Suppression
Time Frame: Baseline (Months 1-12) up to Month 33
The number of patients with HIV RNA less than 200 Copies, during each study time period.
Baseline (Months 1-12) up to Month 33
Number of Mental Health Care Referrals
Time Frame: Baseline (Months 1-12) up to Month 33
The number of referrals to mental health care during a 12 month period, during each study time period.
Baseline (Months 1-12) up to Month 33
Percentage of Mental Health Referrals for YB-GBMSM
Time Frame: Baseline (Months 1-12) up to Month 33
The percentage of mental health referrals by YB-GBMSM clinic patients during each study time period.
Baseline (Months 1-12) up to Month 33

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Sophia Hussen, MD, MPH, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 4, 2021

First Submitted That Met QC Criteria

April 4, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000560
  • R34MH124638 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data will be made available to other researchers, using established public repositories.

IPD Sharing Time Frame

Participant data will be made available for sharing after publication of this study.

IPD Sharing Access Criteria

Data will be available to other researchers using established public repositories.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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