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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04864678
Registration number
NCT04864678
Ethics application status
Date submitted
28/01/2021
Date registered
29/04/2021
Date last updated
28/01/2022
Titles & IDs
Public title
Vaccination Coverage and Uptake in Young People Experiencing or at Risk of Homelessness
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Scientific title
Vaccination Coverage and Uptake in Young People Experiencing or at Risk of Homelessness
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Secondary ID [1]
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60835
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Homeless Youth
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Referral to the Young People's Health Service immunisation nurse
Young people who are experiencing or at risk of homelessness - Young people aged 15-24 years who have accessed a homeless youth service, refuge, or flexible learning center in Melbourne, Australia.
Other interventions: Referral to the Young People's Health Service immunisation nurse
Young people who have been referred to an immunisation nurse at the Young People's Health Service.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of participants referred to the Young People's Health Service immunisation nurse who were up-to-date for their age for vaccines on both the National Immunisation Program and the Victorian State Government Schedule.
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Assessment method [1]
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Young people who meet eligibility criteria will be considered up-to-date on referral if their immunisation history statement at the time of referral meets the criteria to be considered up to date as detailed in Appendix II in the Study Protocol.
The percentage of the young people in the population who are up-to-date for their age with each vaccine will be described.
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Timepoint [1]
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Participants who were referred to the Young People's Health Service between the study time period (Between 19th February 2019 - 19th May 2021)
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Primary outcome [2]
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Proportion of participants referred to the Young People's Health Service immunisation nurse who were are at increased risk of vaccine-preventable diseases.
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Assessment method [2]
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Where available, data collected from the Electronic Medical Records (EMR) will include risk factors for vaccine-preventable diseases and relevant social determinants of health based on the Australian Institute of Health and Welfare, the Australian Government Department of Health and the National Centre for Immunisation Research and Surveillance publications.
Participants will be considered at increased risk of vaccine-preventable diseases if the EMR includes documentation of at least one of: a history of identifying as Aboriginal or Torres Strait Islander, of arriving in Australia as a migrant, refugee or asylum seeker, of incarceration, of men who have sex with men, of alcohol or other drug misuse, of smoking cigarettes, of living with Hepatitis C or HIV, of out of home care, of being a young parent, of having non-professional tattoos, or of sex work.
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Timepoint [2]
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All available medical records for the participant on the Royal Children's Hospital Electronic Medical Records regardless of time frame
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Secondary outcome [1]
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Proportion of participants referred to the Young People's Health Service immunisation nurse who commence a vaccine catch-up plan.
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Assessment method [1]
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Electronic medical records will be reviewed to record the percentage of participants who were not up-to-date with scheduled vaccines for their age on referral, and commenced a vaccine catch-up plan following referral to an immunisation nurse at the Young People's Health Service.
Vaccines required to complete a vaccine catch-up plan will depend on the age of the participant and will be determined by an immunisation nurse.
A participant will be considered to have commenced an immunisation catch-up plan if they receive at least one immunisation on the plan.
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Timepoint [1]
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Between 19th February 2019 - 19th May 2021
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Secondary outcome [2]
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Proportion of participants referred to the Young People's Health Service immunisation nurse who complete a vaccine catch-up plan.
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Assessment method [2]
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Electronic medical records will be reviewed to record the percentage of participants who were not up-to-date with scheduled vaccines for their age, and completed a vaccine catch-up plan following an encounter with an immunisation nurse at the Young People's Health Service.
Vaccines required to complete a vaccine catch-up plan will depend on the age of the participant and will be determined by an immunisation nurse.
A participant will be considered to have completed an immunisation catch-up plan if they receive all immunisations on the plan.
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Timepoint [2]
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Between 19th February 2019 - 19th May 2021
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Secondary outcome [3]
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Mean number of follow-up contact attempts (all types) sent to young people attending the Young People's Health Service per immunisation visit.
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Assessment method [3]
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The mean number of contact attempts sent by staff of the Young People's Health Service to young people who require immunisation catch-up visits. Contact attempts include SMS, email, phone call, in person reminder, and letter.
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Timepoint [3]
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Between 19th February 2019 - 19th May 2021
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Eligibility
Key inclusion criteria
- Is between the ages of 15-24 years inclusive at enrolment
- Has a signed general consent/referral form to the Young People's Health Service
immunisation nurse between 19th February 2019 - 19th July 2020 and scanned into their
EMR. Verbal consent is accepted.
- Was referred from a clinic or outreach location attended by the Young People's Health
Service (i.e. a service for people experiencing homelessness)
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Minimum age
15
Years
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Maximum age
24
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Does not have a signed consent/referral form to Young People's Health Service
immunisation nurse
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/12/2021
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Sample size
Target
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Accrual to date
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Final
400
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Royal Children's Hospital Melbourne - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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RCH League of Former Trainees and Associates Inc
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Royal Children's Hospital
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This retrospective audit will investigate if young people who are homeless or at risk of
homelessness in Melbourne were up-to-date with routine childhood and adolescent vaccines on
first encounter with a nurse-led primary health clinic (the Young People's Health Service),
and if they commenced and completed immunisation catch-up plans following referral to the
Young People's Health Service immunisation nurse.
The purpose of the proposed study is to establish baseline immunisation coverage within the
targeted population, then to explore the impact of an immunisation nurse role on immunisation
coverage in a population of young people aged 15-24 years who are experiencing or at risk of
homelessness.
The Young People's Health Service is a program of the Royal Children's Hospital Department of
Adolescent Medicine. The data collected will be sourced solely from the Royal Children's
Hospital Electronic Medical Records.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04864678
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Belinda L Tominc, MNSc
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Address
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Royal Children's Hospital, Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04864678
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