Clinical trial NCT04833829: Cross-disciplinary HIV Integrated Mental Health Support Intervention
Official title: Cross-disciplinary HIV Integrated Mental Health Support (CHIMES) Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus
HIV Infections
Keywords: Mental health
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-04-06
Enrollment: 850
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Mental Health Visits
timeFrame: Baseline (Months 1-12) up to Month 33
measure: Percentage of Mental Health Visits by YB-GBMSM
timeFrame: Baseline (Months 1-12) up to Month 33
measure: Number of Patients Attending Two HIV Care Visits
timeFrame: Baseline (Months 1-12) up to Month 33
measure: Number of Patients with HIV RNA Viral Suppression
timeFrame: Baseline (Months 1-12) up to Month 33
measure: Number of Mental Health Care Referrals
timeFrame: Baseline (Months 1-12) up to Month 33
measure: Percentage of Mental Health Referrals for YB-GBMSM
timeFrame: Baseline (Months 1-12) up to Month 33
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Infectious Diseases Clinic (Ponce Clinic)
state: Georgia
city: Atlanta
country: United States
facility: Emory Midtown Hospital Infectious Disease Outpatient Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Sophia Hussen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: