Trial Outcomes & Findings for COVID-19 Vaccine Uptake Trial (NCT NCT05419232)

NCT ID: NCT05419232

Last Updated: 2025-04-10

Results Overview

The primary outcome of this study will be the percentage of individuals who received any COVID-19 vaccination within two weeks of a study intervention. Vaccine uptake will be primarily assessed by verbal confirmation of recent vaccination during a follow-up visit with a study team member.

Recruitment status

COMPLETED

Study phase

Target enrollment

262 participants

Primary outcome timeframe

Up to 8 weeks

Results posted on

2025-04-10

Participant Flow

Individuals were recruited from previous COVID-19 testing studies. Individuals were eligible for the study if they were an employee, student, or a family member of a student or employees from nine school districts and charter schools in St. Louis or if they were a resident of St. Louis City or County and were completely unvaccinated for COVID-19. Eligibility expanded to include individuals that were not up to date for their COVID-19 vaccine.

1558 families were called for recruitment, 666 families were screened, 262 individuals were consented, 251 participants received first randomization

Participant milestones

Participant milestones
Measure	Group 1: Call + Call Participants were randomized to Call at timepoint one and Call at timepoint two	Group 2: Call + Text Participants were randomized to Call at timepoint one and Text at timepoint two.	Group 3: Text + Call Participants were randomized to Text at timepoint one and Call at timepoint two.	Group 4: Text + Text Participants were randomized to Text at timepoint one and Text at timepoint two.	Group 5: Call Only Participants were randomized to Call at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.	Group 6: Text Only Participants were randomized to Text at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.
Overall Study STARTED	56	63	52	71	6	3
Overall Study COMPLETED	53	63	52	71	2	0
Overall Study NOT COMPLETED	3	0	0	0	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

COVID-19 Vaccine Uptake Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Call + Call n=56 Participants Participants were randomized to Call at timepoint one and Call at timepoint two	Group 2: Call + Text n=63 Participants Participants were randomized to Call at timepoint one and Text at timepoint two.	Group 3: Text + Call n=52 Participants Participants were randomized to Text at timepoint one and Call at timepoint two.	Group 4: Text + Text n=71 Participants Participants were randomized to Text at timepoint one and Text at timepoint two.	Group 5: Call Only n=6 Participants Participants were randomized to Call at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.	Group 6: Text Only n=3 Participants Participants were randomized to Text at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.	Total n=251 Participants Total of all reporting groups
Age, Continuous	38 Years n=99 Participants	21 Years n=107 Participants	39 Years n=206 Participants	30 Years n=7 Participants	47 Years n=31 Participants	35 Years n=30 Participants	35 Years n=3 Participants
Sex/Gender, Customized Female	44 Participants n=99 Participants	35 Participants n=107 Participants	35 Participants n=206 Participants	47 Participants n=7 Participants	6 Participants n=31 Participants	2 Participants n=30 Participants	169 Participants n=3 Participants
Sex/Gender, Customized Male	12 Participants n=99 Participants	28 Participants n=107 Participants	17 Participants n=206 Participants	23 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants	81 Participants n=3 Participants
Sex/Gender, Customized Other	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants	5 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	11 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=99 Participants	54 Participants n=107 Participants	50 Participants n=206 Participants	68 Participants n=7 Participants	6 Participants n=31 Participants	3 Participants n=30 Participants	233 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	4 Participants n=107 Participants	2 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	7 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	39 Participants n=99 Participants	31 Participants n=107 Participants	29 Participants n=206 Participants	33 Participants n=7 Participants	1 Participants n=31 Participants	2 Participants n=30 Participants	135 Participants n=3 Participants
Race (NIH/OMB) White	14 Participants n=99 Participants	23 Participants n=107 Participants	18 Participants n=206 Participants	32 Participants n=7 Participants	4 Participants n=31 Participants	1 Participants n=30 Participants	92 Participants n=3 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	1 Participants n=7 Participants	1 Participants n=31 Participants	0 Participants n=30 Participants	6 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	9 Participants n=107 Participants	3 Participants n=206 Participants	4 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	17 Participants n=3 Participants
Received COVID-19 Vaccine Yes	24 Participants n=99 Participants	28 Participants n=107 Participants	20 Participants n=206 Participants	37 Participants n=7 Participants	4 Participants n=31 Participants	1 Participants n=30 Participants	114 Participants n=3 Participants
Received COVID-19 Vaccine No	32 Participants n=99 Participants	35 Participants n=107 Participants	32 Participants n=206 Participants	34 Participants n=7 Participants	2 Participants n=31 Participants	2 Participants n=30 Participants	137 Participants n=3 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Outcome measures

Outcome measures
Measure	Group 1: Call + Call n=56 Participants Participants were randomized to Call at timepoint one and Call at timepoint two	Group 2: Call + Text n=63 Participants Participants were randomized to Call at timepoint one and Text at timepoint two.	Group 3: Text + Call n=52 Participants Participants were randomized to Text at timepoint one and Call at timepoint two.	Group 4: Text + Text n=71 Participants Participants were randomized to Text at timepoint one and Text at timepoint two.	Group 5: Call Only n=6 Participants Participants were randomized to Call at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.	Group 6: Text Only n=3 Participants Participants were randomized to Text at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew.
Vaccine Uptake	1 Participants	3 Participants	1 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 8 weeks

The primary outcome of this study will be the percentage of individuals who received any COVID-19 vaccination or indicated they would receive any COVID-19 vaccination within two weeks of a study intervention. Vaccine uptake will be primarily assessed by verbal confirmation of recent vaccination during a follow-up visit with a study team member.