COVID-19
Conditions
Keywords
Healthcare disparities, Vaccine hesitancy
Brief 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. 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.
Interventions
BEHAVIORALCulturally-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.
BEHAVIORALStandard Care
Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.
Sponsors
National Institute of General Medical Sciences (NIGMS)
University of Delaware
ChristianaCare
Nemours Children's Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Youth 0-21 years of age and their caregiver * Receiving care at one of four Nemours primary care practices selected for this study
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Vaccination Rate for Eligible Children | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2,221 |
| 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. | 3,529 |
| Total | 5,750 |
Baseline characteristics
| Characteristic | Culturally-Tailored COVID-19 Vaccine Uptake Intervention | Standard Care | Total |
|---|---|---|---|
| Age, Customized 12-17 | 953 participants | 1544 participants | 2497 participants |
| Age, Customized 5-11 | 1268 participants | 1985 participants | 3253 participants |
| COVID-19 vaccination rate in participating clinics in the month prior to trial | 31.0 Percent of participants vaccinated | 34.8 Percent of participants vaccinated | 33.4 Percent of participants vaccinated |
| Race/Ethnicity, Customized Hispanic | 480 Participants | 511 Participants | 991 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 627 Participants | 1177 Participants | 1804 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 191 Participants | 360 Participants | 551 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 923 Participants | 1481 Participants | 2404 Participants |
| Region of Enrollment United States | 2221 participants | 3529 participants | 5750 participants |
| Sex/Gender, Customized Female | 1049 Participants | 1736 Participants | 2785 Participants |
| Sex/Gender, Customized Male | 1171 Participants | 1793 Participants | 2964 Participants |
| Sex/Gender, Customized Unknown | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,244 | 0 / 3,548 |
| other Total, other adverse events | 0 / 2,244 | 0 / 3,548 |
| serious Total, serious adverse events | 0 / 2,244 | 0 / 3,548 |
Outcome results
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.
Time frame: 4 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Culturally-Tailored COVID-19 Vaccine Uptake Intervention | COVID-19 Vaccination Rate for Eligible Children | Phase 1: Community-Tailored Handouts | 21.3 Percent of participants vaccinated |
| Culturally-Tailored COVID-19 Vaccine Uptake Intervention | COVID-19 Vaccination Rate for Eligible Children | Phase 3: Family-Centered Communication at Primary Care Clinic | 21.9 Percent of participants vaccinated |
| Culturally-Tailored COVID-19 Vaccine Uptake Intervention | COVID-19 Vaccination Rate for Eligible Children | Phase 2: Videos Featuring Local Families | 16.4 Percent of participants vaccinated |
| Culturally-Tailored COVID-19 Vaccine Uptake Intervention | COVID-19 Vaccination Rate for Eligible Children | Phase 4: Community Health Worker Outreach | 14.4 Percent of participants vaccinated |
| Standard Care | COVID-19 Vaccination Rate for Eligible Children | Phase 4: Community Health Worker Outreach | 10.6 Percent of participants vaccinated |
| Standard Care | COVID-19 Vaccination Rate for Eligible Children | Phase 1: Community-Tailored Handouts | 33.5 Percent of participants vaccinated |
| Standard Care | COVID-19 Vaccination Rate for Eligible Children | Phase 2: Videos Featuring Local Families | 26.7 Percent of participants vaccinated |
| Standard Care | COVID-19 Vaccination Rate for Eligible Children | Phase 3: Family-Centered Communication at Primary Care Clinic | 19.4 Percent of participants vaccinated |