Trial Outcomes & Findings for Promoting Altruism to Enhance Vaccine Acceptance (NCT NCT04568590)

Results Overview

8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

510 participants

Primary outcome timeframe

Baseline (Pre-intervention) and Post-Intervention, up to 4 hours

Results posted on

2024-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Vaccine Hesitant Only the Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average \> 3), they will be given the informational handout along with a brief script.
Overall Study STARTED	510
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	437

Reasons for withdrawal

Reasons for withdrawal
Measure	Vaccine Hesitant Only the Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average \> 3), they will be given the informational handout along with a brief script.
Overall Study Subjects were not Vaccine-hesitant	437

Baseline Characteristics

Age not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaccine Hesitant n=73 Participants Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average \> 3), they will be given the informational handout along with a brief script.
Sex: Female, Male Female	0 Participants Gender data not collected
Sex: Female, Male Male	0 Participants Gender data not collected
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=73 Participants
Race (NIH/OMB) Asian	2 Participants n=73 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=73 Participants
Race (NIH/OMB) Black or African American	23 Participants n=73 Participants
Race (NIH/OMB) White	41 Participants n=73 Participants
Race (NIH/OMB) More than one race	0 Participants n=73 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=73 Participants
Region of Enrollment United States	73 participants n=73 Participants

PRIMARY outcome

Timeframe: Baseline (Pre-intervention) and Post-Intervention, up to 4 hours

Population: Population who scored as vaccine hesitant initially who completed both the pre-intervention (N=73) and post-intervention (N=68) aVHS

8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant.

Outcome measures

Outcome measures
Measure	Vaccine Hesitant n=68 Participants Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average \> 3), they will be given the informational handout along with a brief script.
Change in Vaccine Hesitancy Scores Pre- and Post-Intervention.	-0.4 units on a scale Standard Deviation 0.63

PRIMARY outcome

Timeframe: baseline

8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant.

Outcome measures

Outcome measures
Measure	Vaccine Hesitant n=73 Participants Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average \> 3), they will be given the informational handout along with a brief script.
Pre-Intervention Vaccine Hesitancy Score	3.81 units on a scale Standard Deviation 0.61

PRIMARY outcome

Timeframe: Post-Intervention up to 4 Hours

Population: Of our vaccine-hesitant cohort (N=73), only 68 completed the post-intervention aVHS

8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score \>/= 3. Score range is 1-5 and \> or = 3 is considered vaccine hesitant.

Outcome measures

Outcome measures
Measure	Vaccine Hesitant n=68 Participants Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average \> 3), they will be given the informational handout along with a brief script.
Post-Intervention Vaccine Hesitancy Score	3.42 units on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: baseline

Population: We examined this outcome for subjects who completed both the pre-intervention (N=73) and post-intervention (N=68) aVHS

The subject's child's electronic health record will be accessed to document whether that patient received the seasonal influenza vaccine during the baseline visit.

Outcome measures

Outcome measures
Measure	Vaccine Hesitant n=68 Participants Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average \> 3), they will be given the informational handout along with a brief script.
Rate of Influenza Vaccine Uptake	8 Participants

SECONDARY outcome

Timeframe: baseline

Scale ranges from 20-100 with a higher score denoting higher altruism.

Outcome measures

Outcome measures
Measure	Vaccine Hesitant n=68 Participants Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average \> 3), they will be given the informational handout along with a brief script.
Pre-Intervention Altruism Scale	60.4 score on a scale Standard Deviation 13.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 9

Motivational interviews will be conducted with 20 vaccine-hesitant participants, and with four study volunteers. Each motivational interview will be conducted by the same person. Data from these interviews will be entered directly into a Research Electronic Data Capture database and analyzed using Statistical Analysis Software (SAS v9.4).

Outcome measures

Outcome data not reported

Adverse Events

Vaccine Hesitant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Halvorson, MD, MS

Wake Forest University School of Medicine

Phone: 336-716-4999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place