NCT07192419

Brief Summary

The pilot is an intervention of a geriatric assessment and management tool (PATH) in outpatient HIV clinics.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Oct 2025

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Oct 2025Sep 2026

First Submitted

Initial submission to the registry

August 27, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

October 17, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

August 27, 2025

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Feasibility: recruitment and retention

    Feasibility will be measured by tracking the number of participants approached, enrolled, retained, observations by study team throughout study.

    Recruitment day one, throughout the study to final assessment six months post baseline of the last participant.

  • Feasibility: patient/provider experience

    Feasibility will be measured by qualitative Interviews with patients and providers. Interview questions will be used to derive personal anecdotes of the patient/provider experience pertaining to the feasibility of the study.

    After completing final outcomes at the 6 month assessment (or earlier if difficulty with recruitment/retention) patients and providers will be invited to participate in an optional qualitative interview.

  • Acceptability; General attitudes, perception of intervention

    Acceptability will be measured by qualitative Interviews with patients and providers. Interview questions will be used to derive personal anecdotes of the patient/provider general attitudes, perception of intervention.

    After completing final outcomes at the 6 month assessment (or as needed if difficulty with recruitment/retention) patients and providers will be invited to participate in an optional qualitative interview.

Secondary Outcomes (3)

  • Impact of PATH Outcomes: measured by identification of geriatric conditions

    Geriatric Conditions will be measured through chart review at baseline, 3month, and 6 month assessments to determine overall change from baseline.

  • Impact of PATH Outcomes: measured by addressing unmet needs.

    Unmet needs will be measured through survey questions and chart review at baseline, 3month, and 6 month assessments.

  • Quality of life as measured by Medical Outcomes 36-Item Short Form Survey (SF-36)

    Quality of life will be measures at baseline, 3 months and 6 months post baseline assessments.

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care participants will receive HIV and aging information before their regular medical appointment.

PATH

EXPERIMENTAL

The PATH group will undergo an aging assessment using the PATH toolkit before their regular medical appointment.

Behavioral: Promoting Aging and Thriving with HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care Settings

Interventions

For the intervention arm, participants will be sent geriatric assessment questions through the patient portal in advance of a routine HIV appointment. If the participant is unable to complete the questions in advance, they will be done with the help of a research coordinator to go through on the day of appointment. Every attempt will be made to ensure the assessment can be done in advance of the appointment, however the study team will allow for visits after the regular appointment as in which case the provider will receive results after the patient has left clinic. The provider will receive the PATH assessment responses and a discussion guide with suggested initial management steps. The provider ultimately determines with the participant when and if they will address concerns identified (that visit or future visit) based on participant priorities. The patient participant will also receive a copy of their screening results.

PATH

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50 or older
  • Receive HIV care (at least 1 visit at the same site within the past 12 months) from either Eskenazi Health IDC or LifeCare clinics,
  • Able to provide informed consent

You may not qualify if:

  • Patients who are long-term nursing home residents
  • Patients who are receiving geriatric care services, however will liberalize this criteria if difficulty with recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

IU Health LifeCare

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

  • Meredith Greene, MD

    Indiana University School of Medicine, and Regenstrief Institute; IU Center for Aging Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 25, 2025

Study Start

October 17, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations