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Active, Not Recruiting

NCT Number: NCT04833829

Cross-disciplinary HIV Integrated Mental Health Support Intervention

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Emory Midtown Hospital Infectious Disease Outpatient Clinic, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHIMES Intervention

Behavioral

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

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: CHIMES

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2021
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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