Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000090617
Ethics application status
Approved
Date submitted
16/01/2023
Date registered
25/01/2023
Date last updated
17/04/2024
Date data sharing statement initially provided
25/01/2023
Date results provided
17/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Disability and Frailty in People Living with HIV in regional Australia
Scientific title
The presence and severity of episodic disability, and frailty in people living with HIV in regional Australia: A cross-sectional study with a
nested reliability and validity study of the HIV Disability Questionnaire.
Secondary ID [1] 308752 0
nil known
Universal Trial Number (UTN)
Trial acronym
DF-HIVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 328698 0
Episodic Disability 328699 0
Frailty 328700 0
Condition category
Condition code
Public Health 325708 325708 0 0
Other public health
Infection 325709 325709 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Blood 325710 325710 0 0
Other blood disorders
Musculoskeletal 325711 325711 0 0
Other muscular and skeletal disorders
Mental Health 325712 325712 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The primary purpose of this study is to find out how much difficulty people living with HIV (PLHIV) who live in a regional area of Australia, have with everyday tasks, hobbies, sports, jobs, memory, emotion, or participating in social events. These difficulties are known as ‘Disability’ and ‘Frailty’, and we will measure them using three questionnaires. Also, because one of the disability questionnaires is relatively new, we want to compare it with the established disability questionnaire we are using, to test how suitable it is to use for PLHIV in regional Australia. The study will recruit 54 volunteers who are over 18 years old, living with HIV, and attend a Sexual Health Service. Knowing what difficulties PLHIV have will tell us what changes are needed in health and community services to improve their quality of life. This is important, as disability due to HIV leads to a reduced quality of life. So, without a better understanding of disability and frailty in PLHIV, the best services and funding to improve health, function, inclusion in society, and quality of life for this group of people.
This study is clinical health research. This is a cross-sectional study with a nested reliability and validity study. It uses quantitative methods, using self-reported written questionnaires to measure disability and frailty in community-dwelling people living with HIV. Participants will complete the T0 data collection at a face to face 'usual care' sexual health service appointment. T1 data which is completion of one questionnaire, will be conducted at a self selected location (likely to be at their home) prior to mailing back to the chief investigator.
Phase 1: Is a single centre cross-sectional study using self-reported questionnaires to measure disability using the World Health Organisation Disability Assessment Schedule (WHODAS 2.0) and frailty using the Frailty Scale with a single time point data collection per participant (T0). The Questionnaires will take approximately 35 minutes to complete all three.
Phase 2: Comprises a nested construct validity study evaluating the HDQ compared to the WHODAS 2.0 (comparative reference standard) and Frailty Scale, and a repeated measures reliability study of the HDQ when delivered at two time points seven days apart (T0 and T1).
Both Phase 1 and Phase 2 will consist of the same study population/participants.
Intervention code [1] 325211 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333557 0
Disability measured by the HIV Disability Questionnaire (HDQ)
Timepoint [1] 333557 0
baseline (T0) and 7 days (T1) following baseline (T0) HDQ completion
Primary outcome [2] 333558 0
Frailty measured using the 5-question Frailty Scale
Timepoint [2] 333558 0
Baseline (T0)
Primary outcome [3] 333559 0
Disability using the WHODAS-2.0
Timepoint [3] 333559 0
Baseline (T0)
Secondary outcome [1] 417514 0
nil
Timepoint [1] 417514 0
N/A

Eligibility
Key inclusion criteria
- Community dwelling adults (18yrs or over)
-A diagnosis of HIV according to a confirmed Polymerase Chain Reaction (PCR) and Western Blot test.
-Reside within the Townsville Hospital and Health Service area (https://www.health.qld.gov.au/maps) but includes individuals who reside in the communities and surrounding areas of Ayr, Bowen, Chartered Towers, Home Hill, Ingham, and Townsville.
-Attend the TSHS for HIV care
-Willing and able to understand and complete the WHODAS 2.0, Frailty scale and HDQ during their TSHS appointment
-Willing and able to complete a second HDQ at home seven (7) days later and return this to the CI in the addressed and postage paid enveloped provided.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability or unwillingness to provide written consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The number of people living with HIV (PLHIV) attending the study site is approximately 140. Based on previous studies which obtained Cronbach’s alpha of around 0.85 with a 95% CI width of approximately 0.15, a sample size of 54 was calculated based on Bonnett (2002). This sample size is based on test-retest of a single measurement instrument (HDQ) or comparing two measurement instruments (HDQ and WHODAS 2.0 or FS). Assuming a dropout of 20% this means approximately 65 participants should be recruited, which represents approximately 45% of PLHIV attending the study site. Descriptive analysis of the demographics of PLHIV will be undertaken, including mean and standard deviation, or median and inter-quartile range, as appropriate. Given the small population, it is unlikely that any sub-group analysis can be performed. WHODAS 2.0 and FS scores will be calculated and analysed in accordance with the measurement scales’ documentation.
A statistical model with the covariate antiretroviral (ART) regimes, length of time on the regimes, and demographic data will be built in relation to the frailty/disability scores (i.e. Frailty Scale (FS), WHODAS-2, HDQ). Where sufficient data is available individual ART regimes will be used, however if this is not possible, ART regimes will be grouped by those most similar. Alternatively, a cluster analysis of ART regimes and levels of frailty/disability as measured by the FS, WHODAS 2.0, HDQ could be undertaken to explore associations between ART regimes and frailty/disability scores.
Test-retest analysis of the HDQ data will be based on intraclass correlation coefficients (ICC) for consistency (equivalent to Cronbach’s a). Comparison of HDQ domain scores to WHODAAS 2.0 and FS domain scores will use ICCs for consistency (C,k) and absolute agreement (A,k). Data permitting, exploratory models may also be produced. Analysis will be conducted using Stata version 16.1 or above, and R 4.0 or above for modelling.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/04/2021
Date of last participant enrolment
Anticipated
24/12/2024
Actual
21/02/2024
Date of last data collection
Anticipated
31/12/2024
Actual
8/03/2024
Sample size
Target
65
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23829 0
Townsville Sexual Health Services - North Ward
Recruitment postcode(s) [1] 39284 0
4810 - North Ward

Funding & Sponsors
Funding source category [1] 312975 0
University
Name [1] 312975 0
James Cook University
Country [1] 312975 0
Australia
Funding source category [2] 312976 0
Hospital
Name [2] 312976 0
Townsville Hospital and Health Services
Country [2] 312976 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
Discipline of Physiotherapy
Building 043
James Cook University
1 James Cook Drive
Townsville Campus
Douglas
Townsville
4811
QLD
Country
Australia
Secondary sponsor category [1] 314663 0
Hospital
Name [1] 314663 0
Townsville Hospital and Health Services
Address [1] 314663 0
Townsville University Hospital
PO Box 670
Townsville, QLD 4810
Country [1] 314663 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312255 0
Townsville Hospital HREC
Ethics committee address [1] 312255 0
Ethics committee country [1] 312255 0
Australia
Date submitted for ethics approval [1] 312255 0
19/11/2020
Approval date [1] 312255 0
24/11/2020
Ethics approval number [1] 312255 0
HREC
Ethics committee name [2] 312256 0
JCU HREC
Ethics committee address [2] 312256 0
Ethics committee country [2] 312256 0
Australia
Date submitted for ethics approval [2] 312256 0
15/12/2020
Approval date [2] 312256 0
18/01/2021
Ethics approval number [2] 312256 0
H8322

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37710 0
Dr Carol Flavell
Address 37710 0
Room 013-Building 43
James Cook University
Townsville Campus
1 James Cook Drive
Townsville
QLD 4811
Country 37710 0
Australia
Phone 37710 0
+61 747816472
Fax 37710 0
Email 37710 0
[email protected]
Contact person for public queries
Name 37711 0
Carol Flavell
Address 37711 0
Room 013-Building 43
James Cook University
Townsville Campus
1 James Cook Drive
Townsville
QLD 4811
Country 37711 0
Australia
Phone 37711 0
+61 747816472
Fax 37711 0
Email 37711 0
[email protected]
Contact person for scientific queries
Name 37712 0
Carol Flavell
Address 37712 0
Room 013-Building 43
James Cook University
Townsville Campus
1 James Cook Drive
Townsville
QLD 4811
Country 37712 0
Australia
Phone 37712 0
+61 747816472
Fax 37712 0
Email 37712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not approved under ethics for individual data. population anonymised data may be made available on request from pirincipal investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.