ClinicalTrials.gg
RecruitingNCT07486661FrailtyUpdated Mar 20, 2026

A Pilot Project for PLWH Aged 65-75: Preventing the Development of Frailty

An observational study in Age Group: 65-74 and HIV, sponsored by Centre Hospitalier Universitaire Saint Pierre. Recruiting at 1 site in Belgium. Open to participants aged 65 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Centre Hospitalier Universitaire Saint Pierre · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
65 Years to 74 Years
Sex
All
01

Study 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, ... 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:

  1. Determine the proportion and characterize the population of PLWH aged 65 and over who screen positive using the Fried scale
  2. Validate the application of the Fried scale in a population of PLWH
  3. 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
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Conditions studied

  • Age Group: 65-74
  • HIV

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Keywords

  • HIV
  • frailty
  • ageing
03

In context

Frailty

1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.

This study's planned enrollment of 100 is below the median of 225 across 493 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre is the lead sponsor of 78 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

all PLWH followed at the MIA center between 65 and 74 years included

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • living with
  • between 65-74 years

Exclusion criteria

Exclusion Criteria:

  • none
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. Number of PLWH with a Fried test detecting frailty

    Fried scale

    Time frame: Baseline

  2. Number of PLWH with Fried scale detecting pre-frailty condition

    Fried scale

    Time frame: Baseline

  3. 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)

    Time frame: one year after the first Fried scale performed at baseline

Other outcomes

  1. Validate the application of the Fried scale in a population of PLWH

    compared the number of the PLWH with an Fried scale of a score \>/= 2 and the number of PLWH with frailty assessed by a complete geriatrician estimation

    Time frame: This analyse will be done at the end of the study when all patients will have complete the evaluation at one year.

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Study locations

1 of 1 sites recruiting
  • CHU Saint-Pierre, centre MIA
    Brussels, 1000, Belgium
    Recruiting
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References and documents

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 16129869 ↗
  • Fried 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 11253156 ↗
  • Yamada 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 35415198 ↗
  • Jones 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 34799510 ↗
  • Allavena 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 36250271 ↗
  • Wing 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Jul 2028, 35 months after the start.

Of 289 non-industry observational studies under Frailty, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's planned 35 months is above that.

Counting every sponsor, half of 292 studies reached it within 29 months; a quarter within 12 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2026
First posted
Mar 20, 2026
StartActual
Aug 28, 2025
Primary completionEst.
Jul 2028
CompletionEst.
Jul 2028
Last update
Mar 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07486661
Lead sponsor
Centre Hospitalier Universitaire Saint Pierre
Responsible party
Sponsor
First posted
Mar 20, 2026
Start date
Aug 28, 2025
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Mar 20, 2026

Study contacts

Agnes LIBOIS, MD
Contact
maladiesinfectieuses@stpierre-bru.be
+3225354130
Charlotte Martin, MD, PHD
Contact
maladiesinfectieusess@stpierre-bru.be
+3225354130

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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