Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000281695p
Ethics application status
Submitted, not yet approved
Date submitted
14/02/2023
Date registered
15/03/2023
Date last updated
15/03/2023
Date data sharing statement initially provided
15/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Injectable cabotegravir and rilpivirine Observational Study in Australian tertiary and primary care settings. A Cohort Study. (ICAROS)
Scientific title
Injectable cabotegravir and rilpivirine Observational Study in Australian tertiary and primary care settings. of HIV positive adults and primary care workers A Cohort Study. (ICAROS)
Secondary ID [1] 308992 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
ICAROS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 329070 0
Condition category
Condition code
Infection 326001 326001 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
The purpose of this observational study is to observe the experiences of patients and healthcare workers who are involved in the implementation of CAB-RPV LA. The study also will also collate the implementation barriers and solutions to these barriers across the study sites. This study will hope to improve the experience of the patients as well as the health care workers in using this treatment. Information about time required by patients and HCW will also assist HCW plan ahead and find efficient ways of implementing this treatment.
We are achieving this by collecting data on patient reported outcomes, patient satisfaction and quality of life questionnaires before you commence, after your first injection, 6 months and 12 months after commencing Cabenuva to determine if there is an improvement in your experience after 12 months. We have allowed for 20% of participants who have commenced Cabenuva > 1 month ago. If this allocation has been filled, we won’t be able to include any further participants in this category.
Patient commitment will be for 3 questionnaires over 12 months. You will be given an Instruction sheet with a QR code to login to the survey website. Once they scan the QR code and enter the survey website, there will be initial question if you are interested in the study, if yes you will be asked to consent to the study. You will be invited to provide their preferred contact details (e-mail or SMS) so that the follow-up surveys can be sent. They will be provided with a unique study number and given a new page to log onto to complete a series of enrolment questions.
Then at the 6 month and 12 month time point they will be sent a link via SMS or e-mail to go onto to complete the follow-up questionnaires.
Overall the questionnaires should take approx. 15 minutes of your time to complete.
Healthcare workers will complete the same process with questionaires at baseline & Month 12
The PI has approached a number of clinic & hospital staff members caring for high numbers of HIV postitive patients to participate. QR cards & brochures will be available at these clinics for both eligible patients & Healthcare workers.
Intervention code [1] 325434 0
Not applicable
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333857 0
Labelled as composite.

Patient satisfaction and quality of life questionnaires comparing Day 1 administration & 12 months after implementation of this treatment -to determine if there is any change in their experience after 12 months. Composite. Questionaires have been designed specifically for this study
Timepoint [1] 333857 0
Day 1 , Month 3, Month 12 since commencing Cabenuva treatment program
Primary outcome [2] 333858 0
Healthcare worker implementation questionnaires & satisfaction questionaires before administration and at month 12 to see if there is a change at 12 months. Composite. Questionaires have been designed specifically for this study
Timepoint [2] 333858 0
Day 1 & Month 12 since commencing Cabenuva treatment program
Secondary outcome [1] 418489 0
To explore if challenges in using this strategy can be overcome – Health care workers complete questionairres designed specifically for this study
Timepoint [1] 418489 0
Day 1, Month 3 & month 12 since commencing Cabenuva treatment program

Eligibility
Key inclusion criteria
The Principal Investigator has approached GP practises & Hospitals who care for patients living with HIV for their interest in participating & several sites have expressed interest. Participants & Health Care workers who are commencing or recently commenced Cabenuva will be eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
HIV positive patients not on Cabenuva & Health Care workers not administrating or prescribing Cabenuva

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2023
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 313204 0
Commercial sector/Industry
Name [1] 313204 0
ViiV Healthcare Australia
Country [1] 313204 0
Australia
Primary sponsor type
Other
Name
Prahran Market Clinic
Address
Pran Central, Mezzanine Level 325 Chapel Street Prahran 3181 Victoria
Country
Australia
Secondary sponsor category [1] 314924 0
None
Name [1] 314924 0
NONE
Address [1] 314924 0
NONE
Country [1] 314924 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312435 0
Bellberry HREC
Ethics committee address [1] 312435 0
123 Glen Osmond Road Eastwood Adelaide 5063 South Australia
Ethics committee country [1] 312435 0
Australia
Date submitted for ethics approval [1] 312435 0
15/02/2023
Approval date [1] 312435 0
Ethics approval number [1] 312435 0

Summary
Brief summary
The purpose of the ICAROS study is to observe the experiences of patients and health care workers involved in implementing Cabotagravir-Rilpivirine long acting injectable treatment in the Australian setting at both GP clinics and tertiary Institutions.
CAB-RPV LA ( Cabeneva) was approved and re-imbursed by the PBS on 1 April 2022 and presents a new HIV treatment paradigm and new challenges in its implementation.
Hypothesis: The successful implementation of Cabenuva can be achieved by using a mix of different strategies in both primary & tertiary settings.To achieve this objective.:
Patients will complete quality of life and patient satisfaction questionnaires before commencing Cabenuva, after their first injection and at month 12.
Health care workers will complete questionnaires at implementation and at month 12.
Participants will receive a card with a QR code to enter the study, to consent electronically and will be provided with a unique study number.
The data will be stored in RedCap built by the Burnet Institute.To ensure personal information is kept confidential, name, contact details and any other information that allows the participant to be identified directly will be kept separately from all other information collected. Identifying information will not be entered on any study records. Instead, can only be identified by a unique study number. Information will be stored in a secure password
protected database at the Burnet Institute where only the research team has access. All data sent to our servers is encrypted and cannot be tempered with or inspected along the way.
It is hoped to represent under served groups e g women, ageing, culturally and linguistically diverse community, Aboriginal and Torres Strait Islander communities across Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124658 0
Dr Beng Eu
Address 124658 0
Prahran Market Clinic
Pran Central, Mezzanine Level
325 Chapel Street Prahran Victoria 3181
Country 124658 0
Australia
Phone 124658 0
+61 414 282 674
Fax 124658 0
+61 3 9510 8885
Email 124658 0
beng@prahranmarketclinic.com
Contact person for public queries
Name 124659 0
Dr Beng Eu
Address 124659 0
Prahran Market Clinic
Pran Central, Mezzanine Level
325 Chapel Street Prahran Victoria 3181
Country 124659 0
Australia
Phone 124659 0
+61 3 9514 0888
Fax 124659 0
+61 3 9510 8885
Email 124659 0
beng@prahranmarketclinic.com
Contact person for scientific queries
Name 124660 0
Dr Beng Eu
Address 124660 0
Prahran Market Clinic
Pran Central, Mezzanine Level
325 Chapel Street Prahran Victoria 3181
Country 124660 0
Australia
Phone 124660 0
+61 3 9514 0888
Fax 124660 0
+61 3 9510 8885
Email 124660 0
beng@prahranmarketclinic.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only collated final results will be published


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.