Cross-disciplinary HIV Integrated Mental Health Support Intervention
NCT ID: NCT04833829
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
850 participants
INTERVENTIONAL
2020-11-01
2026-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* patient at Grady Health System Infectious Disease Program or Emory University Hospital Midtown Infectious Disease Clinic
Exclusion Criteria
18 Years
29 Years
MALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Emory University
OTHER
Responsible Party
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Sophia Hussen
Associate Professor
Principal Investigators
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Sophia Hussen, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Grady Infectious Diseases Clinic (Ponce Clinic)
Atlanta, Georgia, United States
Emory Midtown Hospital Infectious Disease Outpatient Clinic
Atlanta, Georgia, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY00000560
Identifier Type: -
Identifier Source: org_study_id