Geriatric HIV Cohort in Sub Sahara Africa (HASA)

Diagnosis and Treatment of Non-communicable Diseases and Geriatric Syndromes in the HIV Aging Population in Sub-Saharan Africa

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

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections; Aging; Non Communicable Diseases
• Intervention / Treatment: Drug: Antiretroviral treatment

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Barbara Castelnuovo, PhD; Phone Number: 786623613 786623613; Email: bcastelnuovo@idi.co.ug
• Study Contact Backup: Name: Phoebe Mbabazi, MMed; Phone Number: +256704918966; Email: phibsmm@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Enrollment, year 1, year 2
Change in Quality of life	Quality of life measured using the WHO Quality of life for elderly (WHOQOL-OLD)	Enrollment, year 1, year 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Enrollment, year 1, year 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.	Enrollment, year 1, year 2
Change in proportion of patients with history of falls	Occurrence of falls measured with the History of Falls questionnaire	Enrollment, year 1, year 2
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	Enrollment, year 1, year 2
Change in proportion of patients with depression	Depression measurement using the People Health Questionnaire-9 (scale 0-30, higher: worse)	Enrollment, year 1, year 2
Change in proportion of patients with disability	Assessment of the Instrumental Activities of Daily Living (score 0-8, higher: better)	Enrollment, year 1, year 2
Change in proportion of patients with cognitive deficit	Screening using Montreal Cognitive Assessment (score 0-30; higher: better)	Enrollment, year 1, year 2

Collaborators and Investigators

• Sponsor: Makerere University
• Investigators: Principal Investigator: Barbara Castelnuovo, PhD, Infectious Diseases Institute (IDI)

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Noncommunicable Diseases; Anti-Infective Agents; Antiviral Agents; Anti-Retroviral Agents
• Other Study ID Numbers: TMA2017GSF-1936

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: 2025-2030
• IPD Sharing Access Criteria: Approval from the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No