Homeless YouthNCT04864678
Vaccination Coverage and Uptake in Young People Experiencing or at Risk of Homelessness
An observational study of Homeless Youth, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Homeless Youth
- What is being tested?
- Referral to the Young People's Health Service immunisation nurse
- Type of treatment
- Vaccines
- How many people
- 400 participants
- Where
- 1 siteAustralia
- Study dates
- 21 May 2021to 9 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Young people aged 15-24 years of all genders who have been referred to the Young People's Health Service immunisation nurse will be included. They have accessed a homeless youth service, refuge, or flexible learning centre in Melbourne, Australia. The study will include those who were referred between 19th February 2019 to 19th July 2020.
Who may be able to join
- 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)
Who cannot join
- Does not have a signed consent/referral form to Young People's Health Service immunisation nurse
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Royal Children's Hospital Melbourne
Parkville, Victoria, 3052
About this study
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.
- Conditions
- Homeless Youth
- Being tested
- Referral to the Young People's Health Service immunisation nurse
- Keywords
- homeless youth, vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to the Young People's Health Service immunisation nurseOther
Young people who have been referred to an immunisation nurse at the Young People's Health Service.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Referral to the Young People's Health Service immunisation nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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.
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.
Measured: All available medical records for the participant on the Royal Children's Hospital Electronic Medical Records regardless of time frame
Secondary outcomes (3)
Proportion of participants referred to the Young People's Health Service immunisation nurse who commence a vaccine catch-up plan.
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.
Measured: Between 19th February 2019 - 19th May 2021
Proportion of participants referred to the Young People's Health Service immunisation nurse who complete a vaccine catch-up plan.
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.
Measured: 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.
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.
Measured: Between 19th February 2019 - 19th May 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start21 May 2021
- Primary completion17 Nov 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Homeless YouthStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- RCH League of Former Trainees and Associates Inc, Royal Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Belinda L Tominc, MNSc, Principal investigator, Royal Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864678
- Sponsor's protocol ID
- 60835
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination Coverage and Uptake in Young People Experiencing or at Risk of Homelessness
- ClinicalTrials.gov ID
- NCT04864678
- Acronym / sponsor ID
- 60835
- Conditions
- Homeless Youth
- Keywords
- homeless youth, vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- RCH League of Former Trainees and Associates Inc, Royal Children's Hospital
- Study start
- 21 May 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young people who are experiencing or at risk of homelessness | – | Other: Referral to the Young People's Health Service immunisation nurseYoung people aged 15-24 years who have accessed a homeless youth service, refuge, or flexible learning center in Melbourne, Australia. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Young people aged 15-24 years of all genders who have been referred to the Young People's Health Service immunisation nurse will be included. They have accessed a homeless youth service, refuge, or flexible learning centre in Melbourne, Australia. The study will include those who were referred between 19th February 2019 to 19th July 2020.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Does not have a signed consent/referral form to Young People's Health Service immunisation nurse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral to the Young People's Health Service immunisation nurseYoung people who have been referred to an immunisation nurse at the Young People's Health Service. | Other | Young people who are experiencing or at risk of homelessness |
Primary outcome
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.
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belinda L Tominc, MNSc principal investigator
Royal Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Homeless Youth, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.