Cross-disciplinary HIV Integrated Mental Health Support Intervention

NCT04833829 | Active Not Recruiting

• 2 other identifiers: STUDY00000560R34MH124638
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 2

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.

Conditions

Human Immunodeficiency Virus; HIV Infections

Keywords

Mental health

Outcome Measures

Primary Outcomes (6)

• Number of Mental Health Visits

  The number of mental health visits by clinic patients during each study time period.

  Baseline (Months 1-12) up to Month 33

• Percentage of Mental Health Visits by YB-GBMSM

  The percentage of mental health visits by YB-GBMSM clinic patients during each study time period.

  Baseline (Months 1-12) up to Month 33

• Number of Patients Attending Two HIV Care Visits

  The number of patients who come to two HIV Care visits in a 12 month period, during each study time period.

  Baseline (Months 1-12) up to Month 33

• Number of Patients with HIV RNA Viral Suppression

  The number of patients with HIV RNA less than 200 Copies, during each study time period.

  Baseline (Months 1-12) up to Month 33

• Number of Mental Health Care Referrals

  The number of referrals to mental health care during a 12 month period, during each study time period.

  Baseline (Months 1-12) up to Month 33

• Percentage of Mental Health Referrals for YB-GBMSM

  The percentage of mental health referrals by YB-GBMSM clinic patients during each study time period.

  Baseline (Months 1-12) up to Month 33

Study Arms (3)

Clinic Patients During the Pre-implementation Period

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care

Clinic Patients During the Implementation Period

EXPERIMENTAL

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.

Behavioral: CHIMES Intervention

Clinic Patients During the Maintenance Period

EXPERIMENTAL

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.

Behavioral: CHIMES Intervention

Interventions

CHIMES Intervention BEHAVIORAL

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.

Clinic Patients During the Implementation Period; Clinic Patients During the Maintenance Period

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.

Clinic Patients During the Pre-implementation Period

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Grady Infectious Diseases Clinic (Ponce Clinic)

Atlanta, Georgia, 30308, United States

Location

Emory Midtown Hospital Infectious Disease Outpatient Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections; Psychological Well-Being

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sophia Hussen, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 6, 2021
• Study Start: November 1, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Participant data will be made available for sharing after publication of this study.
• Access Criteria: Data will be available to other researchers using established public repositories.

Locations

US (2)