Impact of PACV Administration on Vaccine Hesitancy

NCT04450940 | Completed

• 1 other identifier: H33255
• Study Type: interventional
• Target: 1,705
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Evaluating Impact of PACV on Vaccine Hesitancy Among Parents of Newborns

Keywords

Parental Attitudes about Childhood Vaccines; vaccine hesitancy

Outcome Measures

Primary Outcomes (1)

• Impact of PACV administration on vaccine hesitancy

  We assessed the change in the proportion of vaccine-hesitant parents between baseline and 6-month follow up

  6 months

Secondary Outcomes (2)

• Prevalence of vaccine hesitancy

  6 months

• Summarize characteristics of vaccine-hesitant parents

  6 months

Study Arms (2)

PACV

EXPERIMENTAL

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.

Behavioral: PACV survey

Placebo

SHAM COMPARATOR

The placebo arm received a placebo survey on general childhood health topics at baseline. All participants received the PACV at 6-month follow up.

Behavioral: Placebo survey

Interventions

PACV survey BEHAVIORAL

PACV

Placebo survey BEHAVIORAL

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Seattle Children's Hospital: collaborator

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinic staff, study authors
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Immunization Project; Associate Professor of Pediatrics

Model Details: Participants were randomized to receive 1 of 2 surveys at enrollment - either the PACV (a survey that identifies vaccine hesitant parents) or a placebo survey on general childhood health topics. 6 months following enrollment, all participants received the PACV, regardless of baseline randomization group.

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: October 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share