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Cross-disciplinary HIV Integrated Mental Health Support Intervention

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04833829
Acronym
CHIMES
Enrollment
850
Registered
2021-04-06
Start date
2020-11-01
Completion date
2026-11-30
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Human Immunodeficiency Virus

Keywords

Mental health

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.

Interventions

BEHAVIORALCHIMES 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.

BEHAVIORALStandard of Care

The standard of care practices of referring patients to mental health services of the clinic during Months 1 - 12 of the study.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Mental Health VisitsBaseline (Months 1-12) up to Month 33The number of mental health visits by clinic patients during each study time period.
Percentage of Mental Health Visits by YB-GBMSMBaseline (Months 1-12) up to Month 33The percentage of mental health visits by YB-GBMSM clinic patients during each study time period.
Number of Patients Attending Two HIV Care VisitsBaseline (Months 1-12) up to Month 33The 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 SuppressionBaseline (Months 1-12) up to Month 33The number of patients with HIV RNA less than 200 Copies, during each study time period.
Number of Mental Health Care ReferralsBaseline (Months 1-12) up to Month 33The number of referrals to mental health care during a 12 month period, during each study time period.
Percentage of Mental Health Referrals for YB-GBMSMBaseline (Months 1-12) up to Month 33The percentage of mental health referrals by YB-GBMSM clinic patients during each study time period.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026