Geriatric HIV Cohort in Sub Sahara Africa

HIV Infections Clinical Trial

— HASA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04313699
• Other study ID #: TMA2017GSF-1936
• Status: Not yet recruiting
• Start date: July 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2020
• Source: Makerere University
• Contact: Barbara Castelnuovo, PhD
• Phone: 786623613
• Email: bcastelnuovo[@]idi.co.ug
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• HIV Infections
• Non Communicable Diseases
• Noncommunicable Diseases

Intervention

Drug:
• Antiretroviral treatment
The cohort will recruit HIV infected participants who are on antiretroviral treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Change in proportion of patients with history of falls	Occurrence of falls measured with the History of Falls questionnaire	Enrollment, year 1, year 2
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in proportion of patients with cognitive deficit	Screening using Montreal Cognitive Assessment (score 0-30; higher: better)	Enrollment, year 1, year 2