NCT07355413

Brief 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. 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. 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).

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
3 countries

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Mar 2029

First Submitted

Initial submission to the registry

January 6, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Expected
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

Same day

First QC Date

January 6, 2026

Last Update Submit

January 14, 2026

Conditions

Keywords

HIVFrailtyGeriatric syndromesCare pathways

Outcome Measures

Primary Outcomes (1)

  • Prevalence of frailty by HIV status among people aged 60 years and older (PA60) in West Africa

    At 12 months

Secondary Outcomes (4)

  • Prevalence of frailty in AP60

    At 12 months

  • Number and proportion of AP60 with geriatric syndrome

    At 12 months

  • Number and proportion of AP60 with at least one comorbidity

    At 12 months

  • Factors associated with the presence of geriatric syndromes

    At t12 months

Study Arms (2)

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.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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
  • Person 60 years of age and older
  • HIV-uninfected
  • Able to move around the data collection site
  • Having given free and informed consent

You may not qualify if:

  • Person deprived of liberty (guardianship, curatorship, judicial safeguard) Karnofsky Index 50≤50% Hospitalized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hôpital de jour du CHU Sourou Sanou

Bobo-Dioulasso, Burkina Faso

Location

Centre Médical de Suivi des donneurs de sang (CMSDS)

Treichville, Abidjan Autonomous District, Côte d’Ivoire

Location

Service des Maladies Infectieuses et Tropicales (SMIT)

Treichville, Abidjan Autonomous District, Côte d’Ivoire

Location

Centre de Prise en Charge de Formation et de Recherche (CEPREF)

Yopougon, Abidjan Autonomous District, Côte d’Ivoire

Location

ONG Espoir Vie Togo

Lomé, Togo

Location

Service des Maladies Infectieuses et Tropicales-CHU Sylvanus Olympio

Lomé, Togo

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clotilde ALLAVENA

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR
  • Raoul MOH

    Programme PAC-CI CHU de Treichville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fifonsi GBEASOR-KOMLANVI

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 21, 2026

Study Start

March 1, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

March 1, 2029

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations