Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07192419

Promoting Aging and Thriving With HIV

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

HIV (Human Immunodeficiency Virus) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Geriatric Geriatric Assessment HIV HIV - Human Immunodeficiency Virus HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Health, Indianapolis, Indiana, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Feasibility: recruitment and retention

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

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

  2. 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.

    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.

  3. 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.

    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.

Secondary outcomes

  1. 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.

    To evaluate the impact of PATH HIV Outcomes the study will look at change from baseline in patient geriatric conditions. This study hypothesizes that compared to usual care, PATH participants will have more geriatric conditions identified and managed as compared to baseline geriatric conditions.

  2. 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.

    Evaluate the impact of PATH HIV on addressing unmet needs of older adults living with HIV. This study hypothesizes that compared to usual care, PATH participants will have more psychosocial needs addressed compared to the number of unmet needs at baseline.

  3. 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.

    Evaluate the preliminary impact of PATH on health-related quality of life for older adults with HIV using the Medical Outcomes 36-Item Short Form Survey (SF-36). This study hypothesizes that compared to usual care, intervention recipients will have improved quality of life as measured by SF-36. 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. These scores can be combined into a Mental Component Summary Score and a Physical Component Summary Score. Component summary scores range from 0 (poor) to 100 (excellent) with the higher scores representing higher physical/mental health respectively.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: PATH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.