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Clinical Trials/NCT04833829
NCT04833829
Active, Not Recruiting
N/A

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

Emory University2 sites in 1 country850 target enrollmentNovember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Human Immunodeficiency Virus
Sponsor
Emory University
Enrollment
850
Locations
2
Primary Endpoint
Number of Mental Health Visits
Status
Active, Not Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
November 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Sequential
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sophia Hussen

Associate Professor

Emory University

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

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

Study Sites (2)

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