HASA: Geriatric HIV Cohort in Sub Sahara Africa

Sponsor
Makerere University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04313699
Collaborator
(none)
500
35.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Diagnosis and Treatment of Non-communicable Diseases and Geriatric Syndromes in the HIV Aging Population in Sub-Saharan Africa
Anticipated Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Change in proportion of participants with any non communicable disease [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)

  2. Change in Quality of life [Enrollment, year 1, year 2]

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

Secondary Outcome Measures

  1. Change in proportion of patients with polypharmacy monitoring [Enrollment, year 1, year 2]

    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

  2. Change in Nutritional status assessed by Mini Nutritional Assessments (MNA) [Enrollment, year 1, year 2]

    Nutrition screening and assessment to identify geriatric patients age who are malnourished or at risk of malnutrition.

  3. Change in proportion of patients with history of falls [Enrollment, year 1, year 2]

    Occurrence of falls measured with the History of Falls questionnaire

  4. Change in proportion of patients with urinary incontinence measured by ICIQ-UI Short [Enrollment, year 1, year 2]

    Presence of urinary incontinence measured with the Internal Consultation on Incontinence Questionnaire

  5. Change in proportion of patients with depression [Enrollment, year 1, year 2]

    Depression measurement using the People Health Questionnaire-9 (scale 0-30, higher: worse)

  6. Change in proportion of patients with disability [Enrollment, year 1, year 2]

    Assessment of the Instrumental Activities of Daily Living (score 0-8, higher: better)

  7. Change in proportion of patients with cognitive deficit [Enrollment, year 1, year 2]

    Screening using Montreal Cognitive Assessment (score 0-30; higher: better)

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Makerere University

Investigators

  • Principal Investigator: Barbara Castelnuovo, PhD, Infectious Diseases Institute (IDI)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Makerere University
ClinicalTrials.gov Identifier:
NCT04313699
Other Study ID Numbers:
  • TMA2017GSF-1936
First Posted:
Mar 18, 2020
Last Update Posted:
Mar 18, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2020