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

Primary Purpose

Human Immunodeficiency Virus, HIV Infections

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHIMES Intervention
Standard of Care
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Human Immunodeficiency Virus focused on measuring Mental health

Eligibility Criteria

18 Years - 29 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Grady Infectious Diseases Clinic (Ponce Clinic)
  • Emory Midtown Hospital Infectious Disease Outpatient Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Clinic Patients During the Pre-implementation Period

Clinic Patients During the Implementation Period

Clinic Patients During the Maintenance Period

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of Mental Health Visits
The number of mental health visits by clinic patients during each study time period.
Percentage of Mental Health Visits by YB-GBMSM
The percentage of mental health visits by YB-GBMSM clinic patients during each study time period.
Number of Patients Attending Two HIV Care Visits
The number of patients who come to two HIV Care visits in a 12 month period, during each study time period.
Number of Patients with HIV RNA Viral Suppression
The number of patients with HIV RNA less than 200 Copies, during each study time period.
Number of Mental Health Care Referrals
The number of referrals to mental health care during a 12 month period, during each study time period.
Percentage of Mental Health Referrals for YB-GBMSM
The percentage of mental health referrals by YB-GBMSM clinic patients during each study time period.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2021
Last Updated
October 18, 2023
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04833829
Brief Title
Cross-disciplinary HIV Integrated Mental Health Support Intervention
Acronym
CHIMES
Official Title
Cross-disciplinary HIV Integrated Mental Health Support (CHIMES) Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, HIV Infections
Keywords
Mental health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinic Patients During the Pre-implementation Period
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Clinic Patients During the Implementation Period
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinic Patients During the Maintenance Period
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CHIMES Intervention
Intervention Description
There are six components to the intervention: Posters and other print materials to prompt providers and patients to discuss MH care engagement. Brief verbal scripts to help HIV providers facilitate patient MH engagement and discuss barriers to MH utilization. Expanded MH screening procedures, including at initial intake. Case management, emphasizing MH care engagement. Interactive trainings for all HIV providers on MH needs, screening/treatment, and barriers to MH service utilization specific to YB-GBMSM. Regular case review meetings.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
The standard of care practices of referring patients to mental health services of the clinic during Months 1 - 12 of the study.
Primary Outcome Measure Information:
Title
Number of Mental Health Visits
Description
The number of mental health visits by clinic patients during each study time period.
Time Frame
Baseline (Months 1-12) up to Month 33
Title
Percentage of Mental Health Visits by YB-GBMSM
Description
The percentage of mental health visits by YB-GBMSM clinic patients during each study time period.
Time Frame
Baseline (Months 1-12) up to Month 33
Title
Number of Patients Attending Two HIV Care Visits
Description
The number of patients who come to two HIV Care visits in a 12 month period, during each study time period.
Time Frame
Baseline (Months 1-12) up to Month 33
Title
Number of Patients with HIV RNA Viral Suppression
Description
The number of patients with HIV RNA less than 200 Copies, during each study time period.
Time Frame
Baseline (Months 1-12) up to Month 33
Title
Number of Mental Health Care Referrals
Description
The number of referrals to mental health care during a 12 month period, during each study time period.
Time Frame
Baseline (Months 1-12) up to Month 33
Title
Percentage of Mental Health Referrals for YB-GBMSM
Description
The percentage of mental health referrals by YB-GBMSM clinic patients during each study time period.
Time Frame
Baseline (Months 1-12) up to Month 33

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia Hussen, MD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Infectious Diseases Clinic (Ponce Clinic)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory Midtown Hospital Infectious Disease Outpatient Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Cross-disciplinary HIV Integrated Mental Health Support Intervention

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