Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Vaccination Coverage and Uptake in Young People Experiencing or at Risk of Homelessness
Secondary ID [1] 0 0
60835
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Homeless Youth 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Participants who were referred to the Young People's Health Service between the study time period (Between 19th February 2019 - 19th May 2021)
Primary outcome [2] 0 0
Proportion of participants referred to the Young People's Health Service immunisation nurse who were are at increased risk of vaccine-preventable diseases.
Timepoint [2] 0 0
All available medical records for the participant on the Royal Children's Hospital Electronic Medical Records regardless of time frame
Secondary outcome [1] 0 0
Proportion of participants referred to the Young People's Health Service immunisation nurse who commence a vaccine catch-up plan.
Timepoint [1] 0 0
Between 19th February 2019 - 19th May 2021
Secondary outcome [2] 0 0
Proportion of participants referred to the Young People's Health Service immunisation nurse who complete a vaccine catch-up plan.
Timepoint [2] 0 0
Between 19th February 2019 - 19th May 2021
Secondary outcome [3] 0 0
Mean number of follow-up contact attempts (all types) sent to young people attending the Young People's Health Service per immunisation visit.
Timepoint [3] 0 0
Between 19th February 2019 - 19th May 2021

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)
Minimum age
15 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Does not have a signed consent/referral form to Young People's Health Service immunisation nurse

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/12/2021
Sample size
Target
Accrual to date
Final
400
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Children's Hospital Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
RCH League of Former Trainees and Associates Inc
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Children's Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04864678
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Belinda L Tominc, MNSc
Address 0 0
Royal Children's Hospital, Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04864678