ClinicalTrials.gg
Not yet recruitingNCT07935434GRACE-HIVUpdated Nov 13, 2026

Effectiveness and Implementation of Geriatrics Resources for Assessment and Care of Elders With HIV (GRACE-HIV)

An interventional study of GRACE-HIV in HIV, Geriatrics and Geriatric Assessment, sponsored by Indiana University. Not yet recruiting. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Indiana University · Not applicable, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
372
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

The GRACE-HIV intervention is a 24-month intervention of RN care coordination guided by a multidisciplinary geriatric and HIV or "GRACE HIV" support team conducted in collaboration with a participant's health care team including any community service providers.

Read the detailed description

The GRACE-HIV intervention is a 24-month intervention of RN care coordination guided by a multidisciplinary geriatric and HIV or "GRACE HIV" support team conducted in collaboration with a participant's health care team including any community service providers. The intervention is designed to integrate geriatric and HIV services to ensure older adults with HIV experiencing poverty receive appropriate and evidence based care for comorbid and geriatric conditions.

02

Conditions studied

  • HIV
  • Geriatrics
  • Geriatric Assessment
  • Collaborative Care
03

In context

Lead sponsor

Indiana University is the lead sponsor of 988 studies on the registry; 200 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Eligible participants will be a) age 50 or older, b) receive care (at least 1 visit at the same site within the past 12 months) from either Eskenazi Health IDC or LifeCare clinics, c) able to provide or have a legally authorized representative provide informed consent based on teach back processes described in recruitment procedures below , d) have a household income below 300% of the federal poverty level, and e) be English or Spanish speaking. The income criteria correspond to the eligibility criteria to receive Ryan White Services in Indiana.

Exclusion criteria

Exclusion Criteria:

  • We will exclude patients who are long-term nursing home residents as the nursing home team is their primary medical team and Ryan White funding does not support long term care services.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
372 participants (estimated)

Study arms

  • Experimental
    GRACE-HIV

    Behavioral: GRACE-HIV

  • No intervention
    Measure of Usual Care

Interventions

  • BehavioralGRACE-HIV

    Each participant randomized to the intervention will undergo an initial visit at their home or preferred location, where the RN will conduct a comprehensive geriatric assessment including physical, cognitive, functional, psychosocial and community needs assessment, and a medication review including prescribed and over the counter medications. After the initial visit, the RN attends the weekly multidisciplinary team meeting to discuss the findings which trigger evidence-based geriatric HIV care protocols for inclusion in the personalized care plan. After multidisciplinary review, the RN will coordinate with the participant's HIV care team, and when relevant, with primary care, specialists, pharmacists, social workers, and community service organizations to refine and implement the care plan.

06

What researchers measure

Primary outcomes

  1. Health Related Quality of Life

    Medical Outcomes Short Form Survey36 (SF-36) to measure health related quality of life. The SF-36 includes eight scales measuring domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Our primary outcome measure is the Component Summary Scores

    Time frame: Baseline, 6month, 12 month, 18month and 24 month.

Secondary outcomes

  1. Geriatric Syndrome Identification and Management

    This outcome is a 24-month participant level Geriatric Syndrome Identification and Management Process Score, derived from EHR, medication, and referral data in both study arms. The composite will be defined as the number of eligible care processes completed divided by the number of eligible care processes during 24 months of follow-up. Components will include: (1) identification of key geriatric syndromes in the EHR, including falls/fall risk, depression, cognitive impairment or dementia, urinary incontinence, and polypharmacy and (2) management of identified syndromes, including medication reconciliation, syndrome-specific treatment or referral, prescribing of indicated medications such as antidepressants or dementia medications when clinically appropriate, and deprescribing of potentially inappropriate medications. Higher scores will indicate better delivery of recommended geriatric care processes.

    Time frame: Baseline, 6month, 12 month, 18month and 24 month.

  2. Acute care healthcare utilization

    We will collect emergency department visits and hospitalization data from the Indiana Network for Patient Care, the health information exchange for the State of Indiana.

    Time frame: Baseline, 6month, 12 month, 18month and 24 month.

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2027; primary completion for Jun 2032, 63 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2026
First posted
Nov 13, 2026
StartEst.
Mar 2027
Primary completionEst.
Jun 2032
CompletionEst.
Jun 2032
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07935434
Lead sponsor
Indiana University
Responsible party
Meredith Greene (Associate Professor of Medicine, Indiana University School of Medicine Division of General Internal Medicine & Geriatrics Research Scientist, Indiana University Center for Aging Research at the Regenstrief Institute, Indiana University) — Principal investigator
First posted
Nov 13, 2026
Start date
Mar 2027 (estimated)
Primary completion
Jun 2032 (estimated)
Completion
Jun 2032 (estimated)
Last update
Nov 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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