Mental Health Support for HIV

(CHIMES Trial)

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

850 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sophia Hussen, MD, MPH

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+