Mental Health Support for HIV

(CHIMES Trial)

Not currently recruiting at 1 trial location

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Emory University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 42

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help young Black gay, bisexual, and other men who have sex with men (YB-GBMSM) engage more effectively with HIV and mental health care at certain clinics. The focus is on improving the use of existing healthcare services, not introducing new treatments. Participants will be grouped based on when they receive care: before, during, or after the introduction of a new intervention, the CHIMES Intervention, at the clinics. This study suits those living with HIV who receive care at Grady Health System or Emory University Hospital Midtown. As an unphased trial, it offers participants the chance to contribute to innovative strategies that could enhance healthcare engagement for their community.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the CHIMES program aims to improve mental health care for young Black gay and bisexual men with HIV. Although specific safety data for this program is unavailable, similar community health programs have been studied. These studies have demonstrated positive effects on mental health, such as reducing depression, suggesting that similar programs are generally safe.

The CHIMES program is not a drug or medical procedure. It focuses on providing support and resources, which usually involves fewer safety concerns than new medications. Designed to enhance connections with health care, these types of support programs typically present minimal risk, even without specific safety data for CHIMES. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new method of integrating mental health support specifically tailored for people living with HIV. Unlike traditional approaches that might treat mental health and HIV separately, this trial looks at a combined approach during different phases: pre-implementation, implementation, and maintenance. This integrated method could lead to more comprehensive care, addressing both physical health and mental well-being simultaneously, which is crucial for improving overall quality of life for HIV patients. By abstracting data from medical records across these different periods, researchers aim to understand how mental health interventions can be effectively woven into existing HIV care practices.

What evidence suggests that this trial's treatments could be effective for mental health support in HIV?

Research has shown that the CHIMES program, an intervention in this trial, helps young Black gay, bisexual, and other men who have sex with men remain engaged in their HIV and mental health care. This program aims to maintain their connection to health services. Studies have found that similar programs can enhance mental health and facilitate access to HIV care. Early results suggest that focusing on mental well-being and reducing HIV-related stigma increases the likelihood of patients adhering to their treatment. The evidence indicates a positive effect on both mental health and continued engagement in HIV care. ^{1 6 7 8 9}

Who Is on the Research Team?

Sophia Hussen, MD, MPH

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for young Black gay, bisexual, and other men who have sex with men (YB-GBMSM) living with HIV. Participants must be patients at Grady Health System Infectious Disease Program or Emory University Hospital Midtown Infectious Disease Clinic.

Inclusion Criteria

I am a young Black gay or bisexual man living with HIV.

Patient at Grady Health System Infectious Disease Program or Emory University Hospital Midtown Infectious Disease Clinic

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Pre-implementation

Data are retroactively abstracted from medical records of patients who had clinic visits prior to the implementation of the CHIMES intervention.

12 months

Clinic visits between January 1, 2019 and December 31, 2019

Implementation

CHIMES intervention is implemented in the clinic settings, with data collection to evaluate effectiveness and implementation processes.

15 months

Continuous data collection during study Months 13 - 27

Maintenance

Data abstraction from medical records to assess the maintenance of the CHIMES intervention.

6 months

Visits during study Months 28 - 33

Follow-up

Participants are monitored for changes in HIV and mental health care engagement after the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CHIMES Intervention
• Standard of Care

Trial Overview The study is testing a new support intervention called CHIMES against the standard care provided in clinics. The goal is to improve how these young men engage with their HIV and mental health treatments.

How Is the Trial Designed?

Group I: Clinic Patients During the Maintenance Period Experimental Treatment 1 Intervention

Patients visiting one of the study clinics during the Maintenance period of the CHIMES intervention. Data will be abstracted from medical records of visits that occur during study Months 28 - 33.

Group II: Clinic Patients During the Implementation Period Experimental Treatment 1 Intervention

Patients visiting one of the study clinics during the Implementation period of the CHIMES intervention. Data will be abstracted from medical records of visits that occur during study Months 13 - 27.

Group III: Clinic Patients During the Pre-implementation Period Active Control 1 Intervention

Patients visiting one of the study clinics prior to implementation of the CHIMES intervention. The Baseline time period consists of study Months 1 - 12. Data are retroactively abstracted from medical records of patients who had clinic visits that occurred between January 1, 2019 and December 31, 2019.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04833829

Cross-disciplinary HIV Integrated Mental Health Support ... The effectiveness of the CHIMES intervention will be measured by change in HIV and MH care engagement before, during, and after CHIMES implementation. The ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK610005/

Interventions to improve mental health and well-being in care ... The CHIMES review is a complex-systems informed, multimethod systematic review that aimed to synthesise extant international evidence on interventions ...

3. publichealth.jhu.edu publichealth.jhu.edu/2024/new-center-provides-resources-for-hiv-related-stigma-research

New Center Provides Resources for HIV-Related Stigma ... The Center will provide resources to researchers whose focus is measuring and reducing HIV-related stigma and its impact on mental health.

4. targethiv.org targethiv.org/sites/default/files/RWNC2020/25590EvaluatingtheImplementation-508.pdf

Evaluating the implementation of an intervention to support ... test different implementation strategies aimed at optimizing the effectiveness of CHIMES and similar interventions for increasing MH service ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0190740923004620

Mental health and wellbeing interventions for care ... The Care-experienced cHildren and young people's Interventions to improve Mental health and wEll-being outcomes Systematic review (CHIMES) aimed to synthesise ...

6. medrxiv.org medrxiv.org/content/10.1101/2025.06.17.25329746v1.full-text

Community Health Intervention through Musical ... The goal of this project was to develop a Community Health Intervention through Music Engagement (CHIME) to support perinatal mental health in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12538517/

Integration of mental health and HIV service delivery in low These studies found consistent positive results on the mental health symptoms of participants, including symptoms of depression and post- ...

8. link.springer.com link.springer.com/article/10.1007/s10935-025-00868-5

Components of Family-Focused Interventions that Have ... Outcome measures included self-report or validated measures of: DVA (including physical, sexual, psychological/emotional, controlling/coercive ...

9. researchgate.net researchgate.net/publication/392828209_Community_Health_Intervention_through_Musical_Engagement_CHIME_in_South_Africa_A_formative_investigation_of_the_feasibility_and_development_of_a_music-based_intervention_to_support_perinatal_mental_he

(PDF) Community Health Intervention through Musical ... Community Health Intervention through Musical Engagement (CHIME) in South Africa: A formative investigation of the feasibility and development ...