Age Group: 65-74FrailtyNCT07486661
A Pilot Project for PLWH Aged 65-75: Preventing the Development of Frailty
An observational study of Age Group: 65-74 and HIV, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
In ageing populations, the main risk is the development of a syndrome of frailty, characterized by the addition of polymorbidity, polymedication, psychosocial difficulties, cognitive disorders, ... Read more about this study
- Who is it for?
- Ages 65 to 74 years
- Conditions the study is for
- Age Group: 65-74, HIV
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Aug 2025to Jul 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 65 to 74 years
- All sexes
- No healthy volunteers
- Older adult
Study population: all PLWH followed at the MIA center between 65 and 74 years included
Who may be able to join
- living with HIV
- between 65-74 years
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU Saint-Pierre, centre MIA
Brussels, 1000
Agnes Libois, MD, +3225354130, maladiesinfectieuses@stpierre-bru.be
Agnes Libois, MD
About this study
In ageing populations, the main risk is the development of a syndrome of frailty, characterized by the addition of polymorbidity, polymedication, psychosocial difficulties, cognitive disorders, ... This functional decline is linked to a reduction in the person's functional reserves, and will lead to an increase in health problems, hospitalizations and, ultimately, mortality. People living with HIV (PLWH) over 50 develop the same kind of comorbidities as HIV-uninfected people over 75 years-old.
In Belgium, the care of PLWH< 75 years with frailty syndrome is not reimbursed by healthcare insurance, and geriatric assessment and management is therefore not possible in this age group, despite the very real need.
Read more
Goals of this project are:
- Determine the proportion and characterize the population of PLWH aged 65 and over who screen positive using the Fried scale
- Validate the application of the Fried scale in a population of PLWH
- Offer a care pathway model to prevent the onset of frailty in people screened as at-risk and who do not benefit from routine screening or care pathway reimbursement.
Projets proposal:
- Systematic screening of all PLWH aged 65-74 at the MIA Center, by the nurse prior to physician consultation, using the Fried scale.
- Send all PLWH aged 65-74 who screen positive to Geriatric One Day for an ergo-geriatric consultation to confirm the risk of frailty and set up a preventive care pathway
- After treatment, perform a patient satisfaction questionnaire + a new Fried scale at one year
- Conditions
- Age Group: 65-74, HIV
- Keywords
- HIV, frailty, ageing
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
number of PLWH between 65 and 74 years with frailty
Using Fried scale and complete geriatic assesment The Fried scale is a widely recognized assessment tool designed to evaluate frailty in older adults, particularly those aged 65 and above. It helps identify individuals at increased risk of adverse health outcomes, such as falls, hospitalization, disability, and mortality. The assessment is based on five key criteria: unintentional weight loss, exhaustion, low physical activity, slowness, and weakness, with each positive criterion scoring one point.
Scores of 0 indicate a robust individual, 1-2 suggest a state of pre-frailty, and ≥3 confirm frailty.
Measured: Baseline
Secondary outcomes (3)
Number of PLWH with a Fried test detecting frailty
Fried scale
Measured: Baseline
Number of PLWH with Fried scale detecting pre-frailty condition
Fried scale
Measured: Baseline
Results of Fried scale at one year
Fried scale performed one year after the first Fried scale in those with a abnormal Fried scale at baseline ( >/=2)
Measured: one year after the first Fried scale performed at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start28 Aug 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Age Group: 65-74Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486661
- Sponsor's protocol ID
- B0762025250403
- Acronym
- Frailty
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
PubMed 16129869Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Yamada Y, Kobayashi T, Condo A, Sangarlangkarn A, Ko F, Taniguchi Y, Kojima G. Prevalence of Frailty and Prefrailty in People With Human Immunodeficiency Virus Aged 50 or Older: A Systematic Review and Meta-Analysis. Open Forum Infect Dis. 2022 Apr 10;9(5):ofac129. doi: 10.1093/ofid/ofac129. eCollection 2022 May.
PubMed 35415198Jones HT, Levett T, Barber TJ. Frailty in people living with HIV: an update. Curr Opin Infect Dis. 2022 Feb 1;35(1):21-30. doi: 10.1097/QCO.0000000000000798.
PubMed 34799510Allavena C, Blain H, Abulizi X, Slama L, Katlama C, Delobel P, Rio V, Cagnot C, Raho-Moussa M, Makinson A, Meyer L. Prevalence and risk factors of frailty among adults living with HIV aged 70 years or older. AIDS. 2023 Jan 1;37(1):183-189. doi: 10.1097/QAD.0000000000003403. Epub 2022 Oct 11.
PubMed 36250271Wing EJ. HIV and aging. Int J Infect Dis. 2016 Dec;53:61-68. doi: 10.1016/j.ijid.2016.10.004. Epub 2016 Oct 15.
PubMed 27756678
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Project for PLWH Aged 65-75: Preventing the Development of Frailty
- ClinicalTrials.gov ID
- NCT07486661
- Acronym / sponsor ID
- Frailty / B0762025250403
- Conditions
- Age Group: 65-74, HIV
- Keywords
- HIV, frailty, ageing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 20 Mar 2026 (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.
In ageing populations, the main risk is the development of a syndrome of frailty, characterized by the addition of polymorbidity, polymedication, psychosocial difficulties, cognitive disorders, ... This functional decline is linked to a reduction in the person's functional reserves, and will lead to an increase in health problems, hospitalizations and, ultimately, mortality. People living with HIV (PLWH) over 50 develop the same kind of comorbidities as HIV-uninfected people over 75 years-old.
In Belgium, the care of PLWH< 75 years with frailty syndrome is not reimbursed by healthcare insurance, and geriatric assessment and management is therefore not possible in this age group, despite the very real need.
Goals of this project are:
- Determine the proportion and characterize the population of PLWH aged 65 and over who screen positive using the Fried scale
- Validate the application of the Fried scale in a population of PLWH
- Offer a care pathway model to prevent the onset of frailty in people screened as at-risk and who do not benefit from routine screening or care pathway reimbursement.
Projets proposal:
- Systematic screening of all PLWH aged 65-74 at the MIA Center, by the nurse prior to physician consultation, using the Fried scale.
- Send all PLWH aged 65-74 who screen positive to Geriatric One Day for an ergo-geriatric consultation to confirm the risk of frailty and set up a preventive care pathway
- After treatment, perform a patient satisfaction questionnaire + a new Fried scale at one year
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 65 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- all PLWH followed at the MIA center between 65 and 74 years included
Key inclusion criteria (2 listed)
- living with HIV
- between 65-74 years
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of PLWH between 65 and 74 years with frailty
Time frame: Baseline
Using Fried scale and complete geriatic assesment The Fried scale is a widely recognized assessment tool designed to evaluate frailty in older adults, particularly those aged 65 and above. It helps identify individuals at increased risk of adverse health outcomes, such as falls, hospitalization, disability, and mortality. The assessment is based on five key criteria: unintentional weight loss, exhaustion, low physical activity, slowness, and weakness, with each positive criterion scoring one point. Scores of 0 indicate a robust individual, 1-2 suggest a state of pre-frailty, and ≥3 confirm frailty.
3 secondary outcomes
Number of PLWH with a Fried test detecting frailty
Time frame: Baseline
Number of PLWH with Fried scale detecting pre-frailty condition
Time frame: Baseline
Results of Fried scale at one year
Time frame: one year after the first Fried scale performed at baseline
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 20 Mar 2026.
- Background: PubMed 16129869Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 35415198Yamada Y, Kobayashi T, Condo A, Sangarlangkarn A, Ko F, Taniguchi Y, Kojima G. Prevalence of Frailty and Prefrailty in People With Human Immunodeficiency Virus Aged 50 or Older: A Systematic Review and Meta-Analysis. Open Forum Infect Dis. 2022 Apr 10;9(5):ofac129. doi: 10.1093/ofid/ofac129. eCollection 2022 May.
- Background: PubMed 34799510Jones HT, Levett T, Barber TJ. Frailty in people living with HIV: an update. Curr Opin Infect Dis. 2022 Feb 1;35(1):21-30. doi: 10.1097/QCO.0000000000000798.
- Background: PubMed 36250271Allavena C, Blain H, Abulizi X, Slama L, Katlama C, Delobel P, Rio V, Cagnot C, Raho-Moussa M, Makinson A, Meyer L. Prevalence and risk factors of frailty among adults living with HIV aged 70 years or older. AIDS. 2023 Jan 1;37(1):183-189. doi: 10.1097/QAD.0000000000003403. Epub 2022 Oct 11.
- Background: PubMed 27756678Wing EJ. HIV and aging. Int J Infect Dis. 2016 Dec;53:61-68. doi: 10.1016/j.ijid.2016.10.004. Epub 2016 Oct 15.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Group: 65-74 and HIV, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Contact Agnes LIBOIS, MD (+3225354130, maladiesinfectieuses@stpierre-bru.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of PLWH between 65 and 74 years with frailty (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07486661, which also lists 6 linked publications.
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 20 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.