Human Immunodeficiency VirusCHIMESNCT04833829
Cross-disciplinary HIV Integrated Mental Health Support Intervention
A study testing CHIMES Intervention in people with Human Immunodeficiency Virus and HIV Infections, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men only
- Conditions the study is for
- Human Immunodeficiency Virus, HIV Infections
- What is being tested?
- CHIMES Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2020to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Infectious Diseases Clinic (Ponce Clinic)
Atlanta, Georgia, 30308
Emory Midtown Hospital Infectious Disease Outpatient Clinic
Atlanta, Georgia, 30322
About this study
Official title: Cross-disciplinary HIV Integrated Mental Health Support (CHIMES) 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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus, HIV Infections
- Being tested
- CHIMES Intervention, Standard of Care
- Keywords
- Mental health
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHIMES InterventionBehavioural
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 CareBehavioural
The standard of care practices of referring patients to mental health services of the clinic during Months 1 - 12 of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: CHIMES Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Mental Health Visits
The number of mental health visits by clinic patients during each study time period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Months 1-12) up to Month 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Nov 2020
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sophia Hussen, Emory University
- Investigators
- Sophia Hussen, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833829
- Sponsor's protocol ID
- STUDY00000560
- Other IDs
- R34MH124638
- Acronym
- CHIMES
- Status last verified
- Nov 2025
- First submitted
- 4 Apr 2021
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be made available to other researchers, using established public repositories.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-disciplinary HIV Integrated Mental Health Support (CHIMES) Intervention
- ClinicalTrials.gov ID
- NCT04833829
- Acronym / sponsor ID
- CHIMES / STUDY00000560
- Conditions
- Human Immunodeficiency Virus, HIV Infections
- Keywords
- Mental health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinic Patients During the Pre-implementation Period | Active comparator | Behavioral: Standard of CarePatients 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. |
| Clinic Patients During the Implementation Period | Experimental | Behavioral: CHIMES InterventionPatients 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. |
| Clinic Patients During the Maintenance Period | Experimental | Behavioral: CHIMES InterventionPatients 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHIMES InterventionThere 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. | Behavioural | Clinic Patients During the Implementation Period, Clinic Patients During the Maintenance Period |
| Standard of CareThe standard of care practices of referring patients to mental health services of the clinic during Months 1 - 12 of the study. | Behavioural | Clinic Patients During the Pre-implementation Period |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified participant data will be made available to other researchers, using established public repositories.
Related trials for Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Hussen, MD, MPH principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHIMES Intervention in people with Human Immunodeficiency Virus and HIV Infections, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Mental Health Visits (time frame: Baseline (Months 1-12) up to Month 33). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.