HIV (Human Immunodeficiency Virus)PATHNCT07192419
Promoting Aging and Thriving With HIV
A study testing Promoting Aging and Thriving with HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care Settings in people with HIV (Human Immunodeficiency Virus) and Geriatric, run by Indiana University at 2 sites in United States.
Trial summary
The pilot is an intervention of a geriatric assessment and management tool (PATH) in outpatient HIV clinics. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), Geriatric, Geriatric Assessment
- What is being tested?
- Promoting Aging and Thriving with HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care Settings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Oct 2025to Sep 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are long-term nursing home residents
- Patients who are receiving geriatric care services, however will liberalize this criteria if difficulty with recruitment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Eskenazi Health
Indianapolis, Indiana, 46202
IU Health LifeCare
Indianapolis, Indiana, 46202
About this study
Official title: Promoting Aging and Thriving With HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care Settings
The pilot is an intervention of a geriatric assessment and management tool (PATH) in outpatient HIV clinics.
Read the 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.
- Conditions
- HIV (Human Immunodeficiency Virus), Geriatric, Geriatric Assessment, HIV, HIV - Human Immunodeficiency Virus
- Being tested
- Promoting Aging and Thriving with HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care Settings
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Aging and Thriving with HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care SettingsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Promoting Aging and Thriving with HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care Settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: recruitment and retention
Feasibility will be measured by tracking the number of participants approached, enrolled, retained, observations by study team throughout study.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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)
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.
Measured: Quality of life will be measures at baseline, 3 months and 6 months post baseline assessments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start17 Oct 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Meredith Greene, Indiana University
- Investigators
- Meredith Greene, MD, Principal investigator, Indiana University School of Medicine, and Regenstrief Institute; IU Center for Aging Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192419
- Sponsor's protocol ID
- 27767
- Other IDs
- K76AG064545-01
- Acronym
- PATH
- Status last verified
- Dec 2025
- First submitted
- 27 Aug 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Aging and Thriving With HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care Settings
- ClinicalTrials.gov ID
- NCT07192419
- Acronym / sponsor ID
- PATH / 27767
- Conditions
- HIV (Human Immunodeficiency Virus), Geriatric, Geriatric Assessment, HIV, HIV - Human Immunodeficiency Virus
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Sep 2025 (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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care participants will receive HIV and aging information before their regular medical appointment. |
| PATH | Experimental | Behavioral: Promoting Aging and Thriving with HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care SettingsThe PATH group will undergo an aging assessment using the PATH toolkit before their regular medical appointment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are long-term nursing home residents
- Patients who are receiving geriatric care services, however will liberalize this criteria if difficulty with recruitment
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 |
|---|---|---|
| Promoting Aging and Thriving with HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care SettingsFor 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. | Behavioural | PATH |
Primary outcome
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.
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.
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.
3 secondary outcomes
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.
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 19 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Meredith Greene, MD principal investigator
Indiana University School of Medicine, and Regenstrief Institute; IU Center for Aging Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting Aging and Thriving with HIV (PATH)-Implementation of a Tailored Geriatric Assessment and Management Strategy for HIV Care Settings in people with HIV (Human Immunodeficiency Virus) and Geriatric, run by Indiana 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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 19 Dec 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?
Feasibility: recruitment and retention (time frame: Recruitment day one, throughout the study to final assessment six months post baseline of the last participant.). The study lists 3 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 19 Dec 2025.