Clinical trial NCT04313699: Geriatric HIV Cohort in Sub Sahara Africa
Official title: Diagnosis and Treatment of Non-communicable Diseases and Geriatric Syndromes in the HIV Aging Population in Sub-Saharan Africa
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Non Communicable Diseases
Aging
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Change in proportion of participants with any non communicable disease
timeFrame: Enrollment, year 1, year 2
measure: Change in Quality of life
timeFrame: Enrollment, year 1, year 2
Secondary outcomes:
measure: Change in proportion of patients with polypharmacy monitoring
timeFrame: Enrollment, year 1, year 2
measure: Change in Nutritional status assessed by Mini Nutritional Assessments (MNA)
timeFrame: Enrollment, year 1, year 2
measure: Change in proportion of patients with history of falls
timeFrame: Enrollment, year 1, year 2
measure: Change in proportion of patients with urinary incontinence measured by ICIQ-UI Short
timeFrame: Enrollment, year 1, year 2
measure: Change in proportion of patients with depression
timeFrame: Enrollment, year 1, year 2
measure: Change in proportion of patients with disability
timeFrame: Enrollment, year 1, year 2
measure: Change in proportion of patients with cognitive deficit
timeFrame: Enrollment, year 1, year 2
Other outcomes:
Locations:
Study officials:
affiliation: Infectious Diseases Institute (IDI)
name: Barbara Castelnuovo, PhD
role: PRINCIPAL_INVESTIGATOR
References: