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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM104941-09S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
| University of Delaware | OTHER |
| ChristianaCare | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culturally-Tailored COVID-19 Vaccine Uptake Intervention | Experimental |
| |
| Standard Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally-Tailored COVID-19 Vaccine Uptake Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thao-Ly T Phan-Vo, MD, MPH | Nemours Children's Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Hospital, Delaware | Wilmington | Delaware | 19803 | United States |
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Patients were counted as participants if they were eligible for but had not received the COVID-19 vaccine at the time of a visit to one of the participating clinics. Because individual patients were counted at the time of their clinic visit and the intervention was implemented in phases, participation differed from phase to phase. While the intervention was delivered to both patient (child) and their parent, only data about the patient (child) was collected from the electronic health record.
Four primary care clinics were recruited to participate in the pilot cluster randomized clinical trial. Primary care clinics were randomized 1:1 to receive the intervention or not, with stratification by geographic region (Northern and Southern Delaware). Because of the cluster randomized nature of the trial and collection of data routinely collected in the electronic health record, a waiver of consent was approved.
| ID | Title | Description |
|---|---|---|
| FG000 | Culturally-Tailored COVID-19 Vaccine Uptake Intervention | Culturally-Tailored COVID-19 Vaccine Uptake Intervention: 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. |
| FG001 | Standard Care | Standard Care: Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Community-Tailored Handouts |
| |||||||||||||
| Phase 2: Videos Featuring Local Families |
| |||||||||||||
| Phase 3: Family-Centered Communication |
| |||||||||||||
| Phase 4:Community Health Worker Outreach |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Culturally-Tailored COVID-19 Vaccine Uptake Intervention | Culturally-Tailored COVID-19 Vaccine Uptake Intervention: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The multi-component intervention was introduced in phases at the two intervention clinics to understand the effect of each component of COVID-19 vaccination. Individual participants were counted if they had a clinic visit during a particular phase of the trial at either of the 2 intervention clinics or two standard care clinic. Because of this, the number analyzed for each phase is different from one another and different from the number analyzed. | Posted | Number | Percent of participants vaccinated | 4 months | Primary care clinic | Primary care clinic |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Culturally-Tailored COVID-19 Vaccine Uptake Intervention | Culturally-Tailored COVID-19 Vaccine Uptake Intervention: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thao-Ly Phan, MD, MPH | Nemours Children's Health | 302-331-7342 | thaoly.phan@nemours.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2021 | Aug 30, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2021 | Aug 30, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard Care | Behavioral | Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers. |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Standard Care | Standard Care: Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| COVID-19 vaccination rate in participating clinics in the month prior to trial | Because this was a cluster randomized controlled trial, we analyzed each participating clinic's COVID-19 vaccination rate in the month prior to the start of the clinical trial to establish a baseline COVID-19 vaccination rate for the groups. In particular, we report the percent of participants vaccinated against COVID-19 at each clinic. | The number of participants represents the number of patients who had a visit to one of the participating primary care clinics (2 in each arm) and were eligible for but had not yet received the COVID-19 vaccine. | Number | Percent of participants vaccinated |
|
Culturally-Tailored COVID-19 Vaccine Uptake Intervention: 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.
| OG001 | Standard Care | Standard Care: Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers. |
|
|
| 0 |
| 2,244 |
| 0 |
| 2,244 |
| 0 |
| 2,244 |
| EG001 | Standard Care | Standard Care: Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers. | 0 | 3,548 | 0 | 3,548 | 0 | 3,548 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| Unknown |
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| Non-Hispanic White |
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| Non-Hispanic Other |
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