HIV InfectionsHASANCT04313699
Geriatric HIV Cohort in Sub Sahara Africa
An observational study of HIV Infections and Non Communicable Diseases, run by Makerere University.
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 Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- HIV Infections, Non Communicable Diseases, Aging
- What is being tested?
- Antiretroviral treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnosis and Treatment of Non-communicable Diseases and Geriatric Syndromes in the HIV Aging Population in Sub-Saharan Africa
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
Read the 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
- Conditions
- HIV Infections, Non Communicable Diseases, Aging
- Being tested
- Antiretroviral treatment
- Medical subject headings
- HIV Infections, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiretroviral treatmentDrug
Also called Assessment of non communicable diseases and geriatric syndromes
The cohort will recruit HIV infected participants who are on antiretroviral treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Enrollment, year 1, year 2
Change in Quality of life
Quality of life measured using the WHO Quality of life for elderly (WHOQOL-OLD)
Measured: Enrollment, year 1, year 2
Secondary outcomes (7)
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
Measured: Enrollment, year 1, year 2
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.
Measured: Enrollment, year 1, year 2
Change in proportion of patients with history of falls
Occurrence of falls measured with the History of Falls questionnaire
Measured: Enrollment, year 1, year 2
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
Measured: Enrollment, year 1, year 2
Change in proportion of patients with depression
Depression measurement using the People Health Questionnaire-9 (scale 0-30, higher: worse)
Measured: Enrollment, year 1, year 2
Change in proportion of patients with disability
Assessment of the Instrumental Activities of Daily Living (score 0-8, higher: better)
Measured: Enrollment, year 1, year 2
Change in proportion of patients with cognitive deficit
Screening using Montreal Cognitive Assessment (score 0-30; higher: better)
Measured: Enrollment, year 1, year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Jul 2020 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Castelnuovo, PhD, Principal investigator, Infectious Diseases Institute (IDI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313699
- Sponsor's protocol ID
- TMA2017GSF-1936
- Acronym
- HASA
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the project the dataset generated from the study will be made available as per the EDCTP Horizon 2020 guidelines. These data will be de-identified prior to sharing widely. The data will be shared in form an excel CSV spreadsheet that will be shared by the PI once the necessary approvals are met. We currently do not have a repository for the data, however at the time of publishing in Open Access Journals, the data will be made available
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment of Non-communicable Diseases and Geriatric Syndromes in the HIV Aging Population in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT04313699
- Acronym / sponsor ID
- HASA / TMA2017GSF-1936
- Conditions
- HIV Infections, Non Communicable Diseases, Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiretroviral treatmentAlso: Assessment of non communicable diseases and geriatric syndromesThe cohort will recruit HIV infected participants who are on antiretroviral treatment | Drug | – |
Primary outcome
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)
7 secondary outcomes
Change in proportion of patients with polypharmacy monitoring
Time frame: Enrollment, year 1, year 2
Change in Nutritional status assessed by Mini Nutritional Assessments (MNA)
Time frame: Enrollment, year 1, year 2
Change in proportion of patients with history of falls
Time frame: Enrollment, year 1, year 2
Change in proportion of patients with urinary incontinence measured by ICIQ-UI Short
Time frame: Enrollment, year 1, year 2
Change in proportion of patients with depression
Time frame: Enrollment, year 1, year 2
Change in proportion of patients with disability
Time frame: Enrollment, year 1, year 2
Change in proportion of patients with cognitive deficit
Time frame: Enrollment, year 1, year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: Yes. At the end of the project the dataset generated from the study will be made available as per the EDCTP Horizon 2020 guidelines. These data will be de-identified prior to sharing widely. The data will be shared in form an excel CSV spreadsheet that will be shared by the PI once the necessary approvals are met. We currently do not have a repository for the data, however at the time of publishing in Open Access Journals, the data will be made available
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Castelnuovo, PhD principal investigator
Infectious Diseases Institute (IDI)
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Non Communicable Diseases, run by Makerere University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Castelnuovo, PhD (786623613 ext. 786623613, bcastelnuovo@idi.co.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proportion of participants with any non communicable disease (time frame: Enrollment, year 1, year 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.