CClinicalTrials.gg
Status unknownNCT04313699HASAUpdated Mar 18, 2020

Geriatric HIV Cohort in Sub Sahara Africa

An observational study in HIV Infections, Non Communicable Diseases and Aging, sponsored by Makerere University. Status unknown. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by Makerere University · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
60 Years and older
Sex
All
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Study summary

The overall goal of the proposal is to improve capacity for detection and management of non-communicable diseases and geriatric syndromes in the aging HIV population in sub-Saharan Africa

Read the detailed description

The establishment and scale up of solid and sustainable HIV programs in sub-Saharan Africa (SSA) has led to a reduction in mortality and morbidity from HIV related opportunistic infections and some HIV related cancers. This improved survival has resulted in two phenomena: the first is the surfacing of non-communicable diseases (NCDs) in the HIV population, especially in those on long-term ART, and the second is increased longevity leading to increasing numbers of elderly HIV infected individuals

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Conditions studied

  • HIV Infections
  • Non Communicable Diseases
  • Aging
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In context

Noncommunicable Diseases

128 studies on the registry are indexed under Noncommunicable Diseases; 44 are open to participants now.

This study's planned enrollment of 500 is below the median of 1,748 across 43 observational studies indexed under Noncommunicable Diseases.

Browse Noncommunicable Diseases studies →

Lead sponsor

Makerere University is the lead sponsor of 143 studies on the registry; 16 are open to participants now.

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

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients 60 years and above at IDI are referred to the elderly specialist clinic, which is run once a week by a physician, therefore study participants will be identified from this clinic. Enrolment into the Geriatric cohort will be offered to all patients 60 years and above attending attending their monthly routine clinic visit at the elderly specialist clinic will be approached by the study staff, will be given detailed information and be asked if they are willing to participate.

Inclusion criteria

Age 60 years and above

  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

Exclusion Criteria:

  • Any clinical (physical and psychiatric) condition which prevents the patients to participate safely in the study procedures according to the judgments of a physician.
  • Subjects already enrolled in experimental clinical trial.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • DrugAntiretroviral treatment

    The cohort will recruit HIV infected participants who are on antiretroviral treatment

    Also known as: Assessment of non communicable diseases and geriatric syndromes

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What researchers measure

Primary outcomes

  1. Change in proportion of participants with any non communicable disease

    Proportion with any non communicable disease (including hypertension, cardio vascular disease, respiratory disease, renal disease, non HIV related cancers, frailty)

    Time frame: Enrollment, year 1, year 2

  2. Change in Quality of life

    Quality of life measured using the WHO Quality of life for elderly (WHOQOL-OLD)

    Time frame: Enrollment, year 1, year 2

Secondary outcomes

  1. Change in proportion of patients with polypharmacy monitoring

    Polypharmacy defined as 5 or more drugs beyond antiretroviral drugs, used in the same individuals for more than 4 weeks. Information of polypharmacy will be collected by the clinic files and self reported by the participants

    Time frame: Enrollment, year 1, year 2

  2. Change in Nutritional status assessed by Mini Nutritional Assessments (MNA)

    Nutrition screening and assessment to identify geriatric patients age who are malnourished or at risk of malnutrition.

    Time frame: Enrollment, year 1, year 2

  3. Change in proportion of patients with history of falls

    Occurrence of falls measured with the History of Falls questionnaire

    Time frame: Enrollment, year 1, year 2

  4. Change in proportion of patients with urinary incontinence measured by ICIQ-UI Short

    Presence of urinary incontinence measured with the Internal Consultation on Incontinence Questionnaire

    Time frame: Enrollment, year 1, year 2

  5. Change in proportion of patients with depression

    Depression measurement using the People Health Questionnaire-9 (scale 0-30, higher: worse)

    Time frame: Enrollment, year 1, year 2

  6. Change in proportion of patients with disability

    Assessment of the Instrumental Activities of Daily Living (score 0-8, higher: better)

    Time frame: Enrollment, year 1, year 2

  7. Change in proportion of patients with cognitive deficit

    Screening using Montreal Cognitive Assessment (score 0-30; higher: better)

    Time frame: Enrollment, year 1, year 2

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes — At the end of the project the dataset generated from the study will be made available as per the EDCTP Horizon 2020 guidelines. These data will be de-identified prior to sharing widely. The data will be shared in form an excel CSV spreadsheet that will be shared by the PI once the necessary approvals are met. We currently do not have a repository for the data, however at the time of publishing in Open Access Journals, the data will be made available

Supporting information: Study protocol, Sap, Csr, Analytic code

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2020, 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
NCT04313699
Lead sponsor
Makerere University
Responsible party
Sponsor
First posted
Mar 18, 2020
Start date
Jul 1, 2020 (estimated)
Primary completion
Jun 30, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Mar 18, 2020

Study contacts

Barbara Castelnuovo, PhD
Contact
bcastelnuovo@idi.co.ug
786623613 ext. 786623613
Phoebe Mbabazi, MMed
Contact
phibsmm@gmail.com
+256704918966
Barbara Castelnuovo, PhD
principal investigator · Infectious Diseases Institute (IDI)

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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