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

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ClinicalTrials.gov Identifier: NCT04833829
Recruitment Status : Enrolling by invitation
First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sophia Hussen, Emory University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus HIV Infections Behavioral: CHIMES Intervention Behavioral: Standard of Care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Cross-disciplinary HIV Integrated Mental Health Support (CHIMES) Intervention
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833829


Locations
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United States, Georgia
Grady Infectious Diseases Clinic (Ponce Clinic)
Atlanta, Georgia, United States, 30308
Emory Midtown Hospital Infectious Disease Outpatient Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Sophia Hussen, MD, MPH Emory University
More Information
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Responsible Party: Sophia Hussen, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT04833829    
Other Study ID Numbers: STUDY00000560
R34MH124638 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant data will be made available to other researchers, using established public repositories.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Participant data will be made available for sharing after publication of this study.
Access Criteria: Data will be available to other researchers using established public repositories.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sophia Hussen, Emory University:
Mental health
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases