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Clinical Trials/NCT04313699
NCT04313699
Unknown
Not Applicable

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

Makerere University0 sites500 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Makerere University
Enrollment
500
Primary Endpoint
Change in proportion of participants with any non communicable disease
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
June 30, 2023
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in proportion of participants with any non communicable disease

Time Frame: 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

Time Frame: Enrollment, year 1, year 2

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

Secondary Outcomes

  • Change in proportion of patients with polypharmacy monitoring(Enrollment, year 1, year 2)
  • Change in Nutritional status assessed by Mini Nutritional Assessments (MNA)(Enrollment, year 1, year 2)
  • Change in proportion of patients with disability(Enrollment, year 1, year 2)
  • Change in proportion of patients with history of falls(Enrollment, year 1, year 2)
  • Change in proportion of patients with urinary incontinence measured by ICIQ-UI Short(Enrollment, year 1, year 2)
  • Change in proportion of patients with depression(Enrollment, year 1, year 2)
  • Change in proportion of patients with cognitive deficit(Enrollment, year 1, year 2)

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