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Enrolling by invitation NCT07192419

Promoting Aging and Thriving With HIV

No phase Interventional HIV (Human Immunodeficiency Virus) Geriatric Geriatric Assessment HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Promoting Aging and Thriving with HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care Settings.
Who it may be relevant to
Registry conditions: HIV (Human Immunodeficiency Virus), Geriatric, Geriatric Assessment, HIV. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

This will be a Pilot, two-arm, randomized parallel-group, clinical trial with blinded research staff of a Geriatric assessment and management tool vs usual care to evaluate the feasibility, acceptability, and preliminary efficacy of the tool on quality of life for older adults with HIV.

Interventions

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

Primary outcome measures

  • Feasibility: recruitment and retention [Time frame: Recruitment day one, throughout the study to final assessment six months post baseline of the last participant.]
  • Feasibility: patient/provider experience [Time frame: 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 [Time frame: 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 outcome measures (3)
  • Impact of PATH Outcomes: measured by identification of geriatric conditions [Time frame: 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. [Time frame: 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) [Time frame: Quality of life will be measures at baseline, 3 months and 6 months post baseline assessments.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Screening

Study locations

United States · 2 centers
  • Eskenazi Health — Indianapolis
  • IU Health LifeCare — Indianapolis

Identifiers

NCT: NCT07192419 · 27767 · K76AG064545-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗