Trial Outcomes & Findings for Improving COVID-19 Vaccine Uptake Among Black and Latino Youth (NCT NCT05293392)
NCT ID: NCT05293392
Last Updated: 2023-09-28
Results Overview
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.
COMPLETED
NA
5792 participants
4 months
2023-09-28
Participant Flow
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.
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.
Unit of analysis: Primary care clinic
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Phase 1: Community-Tailored Handouts
STARTED
|
268 2
|
406 2
|
|
Phase 1: Community-Tailored Handouts
COMPLETED
|
268 2
|
406 2
|
|
Phase 1: Community-Tailored Handouts
NOT COMPLETED
|
0 0
|
0 0
|
|
Phase 2: Videos Featuring Local Families
STARTED
|
281 2
|
476 2
|
|
Phase 2: Videos Featuring Local Families
COMPLETED
|
281 2
|
476 2
|
|
Phase 2: Videos Featuring Local Families
NOT COMPLETED
|
0 0
|
0 0
|
|
Phase 3: Family-Centered Communication
STARTED
|
442 2
|
628 2
|
|
Phase 3: Family-Centered Communication
COMPLETED
|
442 2
|
628 2
|
|
Phase 3: Family-Centered Communication
NOT COMPLETED
|
0 0
|
0 0
|
|
Phase 4:Community Health Worker Outreach
STARTED
|
1230 2
|
2019 2
|
|
Phase 4:Community Health Worker Outreach
COMPLETED
|
1230 2
|
2019 2
|
|
Phase 4:Community Health Worker Outreach
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Culturally-Tailored COVID-19 Vaccine Uptake Intervention
n=2221 Participants
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.
|
Standard Care
n=3529 Participants
Standard Care: Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.
|
Total
n=5750 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
5-11
|
1268 participants
n=2221 Participants
|
1985 participants
n=3529 Participants
|
3253 participants
n=5750 Participants
|
|
Age, Customized
12-17
|
953 participants
n=2221 Participants
|
1544 participants
n=3529 Participants
|
2497 participants
n=5750 Participants
|
|
Sex/Gender, Customized
Female
|
1049 Participants
n=2221 Participants
|
1736 Participants
n=3529 Participants
|
2785 Participants
n=5750 Participants
|
|
Sex/Gender, Customized
Male
|
1171 Participants
n=2221 Participants
|
1793 Participants
n=3529 Participants
|
2964 Participants
n=5750 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=2221 Participants
|
0 Participants
n=3529 Participants
|
1 Participants
n=5750 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
480 Participants
n=2221 Participants
|
511 Participants
n=3529 Participants
|
991 Participants
n=5750 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
627 Participants
n=2221 Participants
|
1177 Participants
n=3529 Participants
|
1804 Participants
n=5750 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
923 Participants
n=2221 Participants
|
1481 Participants
n=3529 Participants
|
2404 Participants
n=5750 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Other
|
191 Participants
n=2221 Participants
|
360 Participants
n=3529 Participants
|
551 Participants
n=5750 Participants
|
|
Region of Enrollment
United States
|
2221 participants
n=2221 Participants
|
3529 participants
n=3529 Participants
|
5750 participants
n=5750 Participants
|
|
COVID-19 vaccination rate in participating clinics in the month prior to trial
|
31.0 Percent of participants vaccinated
n=659 Participants • 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.
|
34.8 Percent of participants vaccinated
n=1174 Participants • 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.
|
33.4 Percent of participants vaccinated
n=1833 Participants • 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.
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Culturally-Tailored COVID-19 Vaccine Uptake Intervention
n=2 Primary care clinic
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.
|
Standard Care
n=2 Primary care clinic
Standard Care: Standard care includes routine offer of the COVID-19 vaccine and counseling about the COVID-19 vaccine by pediatric primary care providers.
|
|---|---|---|
|
COVID-19 Vaccination Rate for Eligible Children
Phase 1: Community-Tailored Handouts
|
21.3 Percent of participants vaccinated
|
33.5 Percent of participants vaccinated
|
|
COVID-19 Vaccination Rate for Eligible Children
Phase 2: Videos Featuring Local Families
|
16.4 Percent of participants vaccinated
|
26.7 Percent of participants vaccinated
|
|
COVID-19 Vaccination Rate for Eligible Children
Phase 3: Family-Centered Communication at Primary Care Clinic
|
21.9 Percent of participants vaccinated
|
19.4 Percent of participants vaccinated
|
|
COVID-19 Vaccination Rate for Eligible Children
Phase 4: Community Health Worker Outreach
|
14.4 Percent of participants vaccinated
|
10.6 Percent of participants vaccinated
|
Adverse Events
Culturally-Tailored COVID-19 Vaccine Uptake Intervention
Standard Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place