Geriatric HIV Cohort in Sub Sahara Africa

NCT04313699 | Unknown

• 1 other identifier: TMA2017GSF-1936
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Conditions

HIV Infections; Non Communicable Diseases; Aging

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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 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

Interventions

Antiretroviral treatment DRUG

The cohort will recruit HIV infected participants who are on antiretroviral treatment

Also known as: Assessment of non communicable diseases and geriatric syndromes

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Makerere University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Packed cells Plasma Serum

MeSH Terms

Conditions

HIV Infections; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Barbara Castelnuovo, PhD

  Infectious Diseases Institute (IDI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Castelnuovo, PhD

CONTACT

786623613; bcastelnuovo@idi.co.ug

Phoebe Mbabazi, MMed

CONTACT

+256704918966; phibsmm@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 18, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 2025-2030
• Access Criteria: Approval from the PI