Older AdultsNCT07355413
Frailty, Geriatric Syndromes and Care Pathways of Older Adults Living With HIV in West Africa
An observational study of Older Adults, run by ANRS, Emerging Infectious Diseases at 6 sites in 3 countries.
Trial summary
With currently available antiretroviral therapy, people living with HIV (PLWHIV) are living longer. This exposure to HIV and combination antiretroviral therapy may accelerate the aging of this population, thus increasing the prevalence of premature frailty. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- How many people
- 600 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 28 Sep 2026to 28 Sep 2029
- Phase
- Observational
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clinical component The targets of this component of the study are two specific populations: * People over the age of 60 (PA60) infected with HIV who are receiving treatment at HIV care centers in Abidjan (Ivory Coast), Bobo-Dioulasso (Burkina Faso), and Lomé (Togo), or who have recently been infected with HIV; * People over the age of 60 who are not infected with HIV. Social science component: * PA60 HIV+/HIV- * Caregivers * Healthcare providers
Who may be able to join
- HIV+ Group
- Person 60 years of age and older
- Infected with HIV-1 and/or 2
- Able to move around the data collection site
- Having given free and informed consent
- HIV- Group
Show all 10Show fewer
- Person 60 years of age and older
- HIV-uninfected
- Able to move around the data collection site
- Having given free and informed consent
Who cannot join
- Person deprived of liberty (guardianship, curatorship, judicial safeguard) Karnofsky Index 50≤50% Hospitalized
- -
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Côte d’Ivoire3 sites, 3 recruiting
- Not yet recruiting
Centre Médical de Suivi des donneurs de sang (CMSDS)
Treichville, Abidjan Autonomous District
- Not yet recruiting
Service des Maladies Infectieuses et Tropicales (SMIT)
Treichville, Abidjan Autonomous District
- Recruiting
Centre de Prise en Charge de Formation et de Recherche (CEPREF)
Yopougon, Abidjan Autonomous District
Togo2 sites, 2 recruiting
- Not yet recruiting
ONG Espoir Vie Togo
Lomé
- Not yet recruiting
Service des Maladies Infectieuses et Tropicales-CHU Sylvanus Olympio
Lomé
Burkina Faso1 site, 1 recruiting
- Not yet recruiting
Hôpital de jour du CHU Sourou Sanou
Bobo-Dioulasso
About this study
With currently available antiretroviral therapy, people living with HIV (PLWHIV) are living longer. This exposure to HIV and combination antiretroviral therapy may accelerate the aging of this population, thus increasing the prevalence of premature frailty.
There are few data on the prevalence of frailty and geriatric syndromes among older people living with HIV (OpHIV) in sub-Saharan Africa (SSA) and the screening and diagnostic tools to identify them.
Read more
The initiation contract financed by the ANRS-MIE in 2021 whose objective was to 1) carry out an inventory and evaluate the feasibility of a project for monitoring OpHIV in Burkina-Faso in Côte d'Ivoire and Togo and 2) to select the collection tools adapted to the description of geriatric syndromes in these elderly people has allowed to highlight the following (i) The collection of data on geriatric conditions and syndromes is almost non-existent in the daily care and management practice (ii) there is a significant proportion (10,6%) of PLWHIV aged 60 years and over in the active files of the PLWHIV care centers that participated in the survey (iii) Adapted screening tools have been selected and will allow documentation of the above-mentioned syndromes. This research project, which follows on from this initiation contract, will therefore make it possible to obtain data from the geriatric evaluation, to identify the specificities of PLWHIV by comparing them to a population not infected with HIV and to propose geriatric management adapted to PLWHIV. Its innovative nature also lies in its mixed approach combining quantitative and qualitative methods, which will make it possible to document the needs and resources for the care of PLWHIV in a global and holistic manner.
600 participants, aged 60 years and over (300 living with HIV and 300 not living with HIV), in three West African countries (Burkina Faso, Côte d'Ivoire, Togo) will be included in this study whose primary objective is to compare the prevalence of frailty among people aged 60 years and over (PA60) between HIV-infected and non-HIV-infected; the secondary objective is to estimate the prevalence of frailty among PA60 according to HIV status. A population-based matching will be performed on sex and age class (threshold 70 years), during the recruitment of HIV- PA60.
This will be a mixed study combining:
- A "clinical" component comprising a stratified, comparative, international, multicenter cross-sectional study;
- A "health systems strengthening" component combining a quantitative cross-sectional survey and a qualitative survey;
- A qualitative socio-anthropological component including individual interviews and focus groups with people living with HIV60, their families and caregivers.
The 3 components will be conducted with a time lag between the different components due to the overlapping constitution of the source populations.
Most research on aging with HIV in the context of SSA has been very clinically focused (e.g., frailty or cognitive impairment). This research will provide a more comprehensive approach that takes into account the different levels of factors influencing health (individual, health system, social environment).
Read the detailed description
Methodology:
This is a mixed study combining:
- a "clinical" component comprising a comparative, international, multicenter, two-strata (HIV+ and HIV-) cross-sectional study;
- a "social sciences" component combining a quantitative cross-sectional survey and a qualitative survey involving individual interviews and focus groups with PA60, their families and caregivers.
Interventions:
- Screening for several comorbidities (high blood pressure, diabetes, dyslipidemia, kidney failure, undernutrition, depression).
- Comprehensive management including prevention strategies adapted to the various comorbidities mentioned above and their complications.
Statistical method:
Use of mixed approaches. For quantitative indicators, descriptive analysis techniques, bivariate analysis (Student t test or Wilcoxon test for quantitative variables, Chi² or Fisher test for categorical variables) and multivariate analysis (logistic regression).
- Conditions
- Older Adults
- Keywords
- HIV, Frailty, Geriatric syndromes, Care pathways
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive group | Individuals aged 60 years and over living with HIV-1 and/or HIV-2 attending HIV care centers in Abidjan, Bobo-Dioulasso and Lomé. | |
| HIV negative group | Individuals aged 60 years and over without HIV, matched by sex and age group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of frailty by HIV status among people aged 60 years and older (PA60) in West Africa
Measured: At 12 months
Secondary outcomes (4)
Prevalence of frailty in AP60
Measured: At 12 months
Number and proportion of AP60 with geriatric syndrome
Including cognitive, visual and hearing disorders, depression, undernutrition, dehydration, pain, urinary and fecal continence disorders, gait and balance disorders, according to HIV status
Measured: At 12 months
Number and proportion of AP60 with at least one comorbidity
Including cancer, dyslipidemia, diabetes, hypertension, history of myocardial infarction or stroke, osteoarticular disease, renal failure, according to HIV status
Measured: At 12 months
Factors associated with the presence of geriatric syndromes
Measured: At t12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start28 Sep 2026
- Primary completionSep 2029 (estimated)
- Study completion28 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Clotilde ALLAVENA, Principal investigator, Nantes University HospitalRaoul MOH, Principal investigator, Programme PAC-CI CHU de Treichville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355413
- Sponsor's protocol ID
- ANRS 0496s FraGericare-WA
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No