COVID-19NCT05293392
Improving COVID-19 Vaccine Uptake Among Black and Latino Youth
A study testing Culturally-Tailored COVID-19 Vaccine Uptake Intervention in people with COVID-19, run by Nemours Children's Health System at 1 site in United States.
Trial summary
Black and Latino youth may be less likely to get the COVID-19 vaccine than White youth. In this study we will work with community members to come up with ways to help Black and Latino families learn more about the COVID-19 vaccine and get the COVID-19 vaccine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- Culturally-Tailored COVID-19 Vaccine Uptake Intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,792 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2022to 20 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Youth 0-21 years of age and their caregiver
- Receiving care at one of four Nemours primary care practices selected for this study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803
About this study
Official title: Improving Pediatric COVID-19 Vaccine Awareness, Access, and Accountability in Underrepresented Communities
Black and Latino youth may be less likely to get the COVID-19 vaccine than White youth. In this study we will work with community members to come up with ways to help Black and Latino families learn more about the COVID-19 vaccine and get the COVID-19 vaccine. We will test these ideas out in pediatric primary care clinics. This study will help us make sure that all youth have an equal chance of getting the COVID-19 vaccine.
- Conditions
- COVID-19
- Being tested
- Culturally-Tailored COVID-19 Vaccine Uptake Intervention, Standard Care
- Keywords
- Healthcare disparities, Vaccine hesitancy
- Medical subject headings
- COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally-Tailored COVID-19 Vaccine Uptake InterventionBehavioural
This is a multi-component intervention to increase COVID-19 vaccine uptake among youth that was co-created with community partners and refined with qualitative feedback from Black and Latino youth and parents. The intervention consists of culturally-tailored educational materials to increase awareness about the COVID-19 vaccine, culturally-sensitive communication strategies employed by pediatric primary care providers and community health workers, and strategies to facilitate and standardize access to the COVID-19 vaccine in the primary care clinic.
Standard CareBehavioural
Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.
| Study group | Role | What they receive |
|---|---|---|
| Culturally-Tailored COVID-19 Vaccine Uptake Intervention | Experimental | Not described Receives: Behavioral: Culturally-Tailored COVID-19 Vaccine Uptake Intervention |
| Standard Care | Active comparator | Not described Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Vaccination Rate for Eligible Children
Percent of patients who received a COVID-19 vaccine among all children who were eligible for and had not yet been vaccinated for the COVID-19 vaccine during the time of their visit to one of the four participating primary care clinics.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start31 Jan 2022
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,792 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), University of Delaware, ChristianaCare
- Responsible party
- Principal investigator, Thao-Ly Phan, Nemours Children's Health System
- Investigators
- Thao-Ly T Phan-Vo, MD, MPH, Principal investigator, Nemours Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293392
- Sponsor's protocol ID
- U54GM104941-09S1
- Other IDs
- U54GM104941-09S1
- Status last verified
- Aug 2023
- First submitted
- 22 Mar 2022
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pediatric COVID-19 Vaccine Awareness, Access, and Accountability in Underrepresented Communities
- ClinicalTrials.gov ID
- NCT05293392
- Acronym / sponsor ID
- U54GM104941-09S1
- Conditions
- COVID-19
- Keywords
- Healthcare disparities, Vaccine hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,792 participants (actual)
- Lead sponsor
- Nemours Children's Health SystemUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), University of Delaware, ChristianaCare
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Black and Latino youth may be less likely to get the COVID-19 vaccine than White youth. In this study we will work with community members to come up with ways to help Black and Latino families learn more about the COVID-19 vaccine and get the COVID-19 vaccine. We will test these ideas out in pediatric primary care clinics. This study will help us make sure that all youth have an equal chance of getting the COVID-19 vaccine.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally-Tailored COVID-19 Vaccine Uptake Intervention | Experimental | Behavioral: Culturally-Tailored COVID-19 Vaccine Uptake Intervention |
| Standard Care | Active comparator | Behavioral: Standard Care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Youth 0-21 years of age and their caregiver
- Receiving care at one of four Nemours primary care practices selected for this study
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Culturally-Tailored COVID-19 Vaccine Uptake InterventionThis is a multi-component intervention to increase COVID-19 vaccine uptake among youth that was co-created with community partners and refined with qualitative feedback from Black and Latino youth and parents. The intervention consists of culturally-tailored educational materials to increase awareness about the COVID-19 vaccine, culturally-sensitive communication strategies employed by pediatric primary care providers and community health workers, and strategies to facilitate and standardize access to the COVID-19 vaccine in the primary care clinic. | Behavioural | Culturally-Tailored COVID-19 Vaccine Uptake Intervention |
| Standard CareStandard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers. | Behavioural | Standard Care |
Primary outcome
COVID-19 Vaccination Rate for Eligible Children
Time frame: 4 months
Percent of patients who received a COVID-19 vaccine among all children who were eligible for and had not yet been vaccinated for the COVID-19 vaccine during the time of their visit to one of the four participating primary care clinics.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Thao-Ly T Phan-Vo, MD, MPH principal investigator
Nemours Children's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally-Tailored COVID-19 Vaccine Uptake Intervention in people with COVID-19, run by Nemours Children's Health System at 1 site in United States.
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 2 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 Sep 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
COVID-19 Vaccination Rate for Eligible Children (time frame: 4 months). 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 Sep 2023.