Cross-disciplinary HIV Integrated Mental Health Support Intervention

HIV Infections Clinical Trial

— CHIMES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04833829
• Other study ID #: STUDY00000560
• Secondary ID: R34MH124638
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 850
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Behavioral:
• CHIMES Intervention
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.
• 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.

Locations

Country	Name	City	State
United States	Emory Midtown Hospital Infectious Disease Outpatient Clinic	Atlanta	Georgia
United States	Grady Infectious Diseases Clinic (Ponce Clinic)	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Mental Health Visits	The number of mental health visits by clinic patients during each study time period.	Baseline (Months 1-12) up to Month 33
Primary	Percentage of Mental Health Visits by YB-GBMSM	The percentage of mental health visits by YB-GBMSM clinic patients during each study time period.	Baseline (Months 1-12) up to Month 33
Primary	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.	Baseline (Months 1-12) up to Month 33
Primary	Number of Patients with HIV RNA Viral Suppression	The number of patients with HIV RNA less than 200 Copies, during each study time period.	Baseline (Months 1-12) up to Month 33
Primary	Number of Mental Health Care Referrals	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
Primary	Percentage of Mental Health Referrals for YB-GBMSM	The percentage of mental health referrals by YB-GBMSM clinic patients during each study time period.	Baseline (Months 1-12) up to Month 33