- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04864678
Vaccination Coverage and Uptake in Young People Experiencing or at Risk of Homelessness
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Victoria
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Parkville, Victoria, Australia, 3052
- The Royal Children's Hospital Melbourne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Exclusion Criteria:
- Does not have a signed consent/referral form to Young People's Health Service immunisation nurse
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Young people who have been referred to an immunisation nurse at the Young People's Health Service.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Participants who were referred to the Young People's Health Service between the study time period (Between 19th February 2019 - 19th May 2021)
|
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. |
Participants who were referred to the Young People's Health Service between the study time period (Between 19th February 2019 - 19th May 2021)
|
Proportion of participants referred to the Young People's Health Service immunisation nurse who were are at increased risk of vaccine-preventable diseases.
Time Frame: All available medical records for the participant on the Royal Children's Hospital Electronic Medical Records regardless of time frame
|
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. |
All available medical records for the participant on the Royal Children's Hospital Electronic Medical Records regardless of time frame
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants referred to the Young People's Health Service immunisation nurse who commence a vaccine catch-up plan.
Time Frame: Between 19th February 2019 - 19th May 2021
|
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. |
Between 19th February 2019 - 19th May 2021
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Proportion of participants referred to the Young People's Health Service immunisation nurse who complete a vaccine catch-up plan.
Time Frame: Between 19th February 2019 - 19th May 2021
|
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. |
Between 19th February 2019 - 19th May 2021
|
Mean number of follow-up contact attempts (all types) sent to young people attending the Young People's Health Service per immunisation visit.
Time Frame: Between 19th February 2019 - 19th May 2021
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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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Between 19th February 2019 - 19th May 2021
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Collaborators and Investigators
Investigators
- Principal Investigator: Belinda L Tominc, MNSc, Royal Children's Hospital, Melbourne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 60835
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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