Impact of PACV Administration on Vaccine Hesitancy

June 25, 2020 updated by: Julie Boom, Baylor College of Medicine

Examining the Impact of PACV Administration on Vaccine Hesitancy: a Randomized Control Trial, Houston, TX

Our objective is to assess the impact of administering the PACV to parents of newborns. We also sought to assess the prevalence of vaccine hesitancy among parents of newborns in Houston, TX and to characterize the demographics of vaccine-hesitant parents.

Study Overview

Detailed Description

Despite overwhelming scientific evidence demonstrating the safety and effectiveness of vaccines, parental immunization concerns continue to increase. Compared to parents who refuse all vaccines, vaccine-hesitant parents (VHP), defined as parents who are ambivalent towards vaccines, are of particular interest because they tend to be more amenable to vaccination. VHPs tend to be part of a larger group of parents with moderate vaccine concerns who seek additional information from their healthcare provider before deciding whether or not to immunize. These parents will sometimes immunize after education and reassurance from their provider. Alternatively, they may choose to delay or refuse certain vaccines. It is important to identify VHPs early in the medical relationship to provide effective communication and appropriate education regarding vaccine concerns in order to ensure maximum immunization coverage for the children of these parents.

The Parent Attitudes about Childhood Vaccines (PACV) survey was previously developed to identify VHPs. In a follow up study, the survey was validated and found to be a reliable instrument in identifying VHPs. The PACV survey differs from other survey instruments in that it seeks to specifically identify VHPs. Moreover, the survey was found to be a reliable predictor of immunization status with higher total PACV scores associated with under-immunization.5 It is unknown if administering the PACV survey can have a negative impact on parental immunization beliefs or if the PACV survey can elicit vaccine concerns that otherwise would not have been present at that point in time.

Study enrollment will occur among parents/guardians of children who are scheduled at a Texas Children's Pediatric practice for an 2-week well child visit. Parents/guardians of children will receive an enrollment packet containing a self-screening form, cover letter, and survey from the practice staff at their appointment check-in. Parents will be randomized to receive 1 of 2 surveys - either the PACV or a placebo survey about general childhood health topics. Upon receipt of the enrollment packet, the parent/guardian will be asked to complete a self-screening form to determine if they meet eligibility criteria. If the parent/guardian does not meet eligibility criteria the self-screening form will direct them to return the enrollment packet unopened to the front desk staff. Parents/guardians of children meeting eligibility criteria will be directed to open the enrollment packet and complete the survey. The PACV survey will then be administered to all subjects six months following the initial survey administration.

Prevalence of vaccine hesitancy will be calculated for each group (initial PACV or placebo survey) separately and then for both groups combined. PACV scores calculated from the second administration at 6 months will be compared across groups to evaluate if administration of the PACV increases vaccine hesitancy.

Inclusion criteria:

  1. Person must self-identify as English-speaking.
  2. Parent of a child less than 3 months of age.
  3. Parent must be 18 years of age or older.
  4. Parent of a child seeking routine, well-child care at a selected TCP practice site.

Exclusion criteria:

  1. Person does not self-identify as English-speaking.
  2. Parent of child greater than 3 months of age.
  3. Parent is less than 18 years of age.
  4. Parent of child not seeking routine, well-child care at a selected TCP practice site.

Study Type

Interventional

Enrollment (Actual)

1705

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Person must self-identify as English-speaking.
  2. Parent of a child less than 3 months of age.
  3. Parent must be 18 years of age or older.
  4. Parent of a child seeking routine, well-child care at a selected TCP practice site.

Exclusion Criteria:

  1. Person does not self-identify as English-speaking.
  2. Parent of child greater than 3 months of age.
  3. Parent is less than 18 years of age.
  4. Parent of child not seeking routine, well-child care at a selected TCP practice site.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PACV
The PACV arm received the PACV survey at baseline in order to assess the impact of administration on vaccine hesitancy. All participants received the PACV at 6-month follow up.
Sham Comparator: Placebo
The placebo arm received a placebo survey on general childhood health topics at baseline. All participants received the PACV at 6-month follow up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of PACV administration on vaccine hesitancy
Time Frame: 6 months
We assessed the change in the proportion of vaccine-hesitant parents between baseline and 6-month follow up
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of vaccine hesitancy
Time Frame: 6 months
We assessed the proportion of vaccine-hesitant parents
6 months
Summarize characteristics of vaccine-hesitant parents
Time Frame: 6 months
We sought to summarize the demographic characteristics of vaccine-hesitant parents and examine associations between vaccine hesitancy and participant characteristics
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • H33255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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