Geriatric HIV Cohort in Sub Sahara Africa

• Conditions: HIV Infections; Aging; Non Communicable Diseases

• Registration Number: NCT04313699
• Lead Sponsor: Makerere University

Brief 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

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

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-16
• Last Update Submitted: 2020-03-16
• Study First Posted: 2020-03-18
• Last Update Posted: 2020-03-18
• Study Start: 2020-07-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in proportion of participants with any non communicable disease	Enrollment, year 1, year 2	Proportion with any non communicable disease (including hypertension, cardio vascular disease, respiratory disease, renal disease, non HIV related cancers, frailty)
Change in Quality of life	Enrollment, year 1, year 2	Quality of life measured using the WHO Quality of life for elderly (WHOQOL-OLD)

Secondary Outcome Measures

Name	Time	Method
Change in proportion of patients with polypharmacy monitoring	Enrollment, year 1, year 2	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
Change in Nutritional status assessed by Mini Nutritional Assessments (MNA)	Enrollment, year 1, year 2	Nutrition screening and assessment to identify geriatric patients age who are malnourished or at risk of malnutrition.
Change in proportion of patients with disability	Enrollment, year 1, year 2	Assessment of the Instrumental Activities of Daily Living (score 0-8, higher: better)
Change in proportion of patients with history of falls	Enrollment, year 1, year 2	Occurrence of falls measured with the History of Falls questionnaire
Change in proportion of patients with urinary incontinence measured by ICIQ-UI Short	Enrollment, year 1, year 2	Presence of urinary incontinence measured with the Internal Consultation on Incontinence Questionnaire
Change in proportion of patients with depression	Enrollment, year 1, year 2	Depression measurement using the People Health Questionnaire-9 (scale 0-30, higher: worse)
Change in proportion of patients with cognitive deficit	Enrollment, year 1, year 2	Screening using Montreal Cognitive Assessment (score 0-30; higher: better)