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Evaluating Impact of PACV on Vaccine Hesitancy Among Parents of NewbornsNCT04450940

Impact of PACV Administration on Vaccine Hesitancy

A study testing PACV survey in people with Evaluating Impact of PACV on Vaccine Hesitancy Among Parents of Newborns, run by Baylor College of Medicine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
PACV survey
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,705 participants
Where
No sites listed yet
Study dates
Oct 2013to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: 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.

Read the 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.
Being tested
PACV survey, Placebo survey
Keywords
Parental Attitudes about Childhood Vaccines, vaccine hesitancy
Medical subject headings
Vaccination Hesitancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PACV surveyBehavioural

  • Placebo surveyBehavioural

Study groups in NCT04450940
Study groupRoleWhat they receive
PACVExperimentalThe 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.
Receives: Behavioral: PACV survey
PlaceboSham comparatorThe placebo arm received a placebo survey on general childhood health topics at baseline. All participants received the PACV at 6-month follow up.
Receives: Behavioral: Placebo survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (2)
  1. Prevalence of vaccine hesitancy

    We assessed the proportion of vaccine-hesitant parents

    Measured: 6 months

  2. Summarize characteristics of vaccine-hesitant parents

    We sought to summarize the demographic characteristics of vaccine-hesitant parents and examine associations between vaccine hesitancy and participant characteristics

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study startOct 2013
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
1,705 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04450940
Sponsor's protocol ID
H33255
Status last verified
Jun 2020
First submitted
25 Jun 2020
Last updated
30 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PACV survey in people with Evaluating Impact of PACV on Vaccine Hesitancy Among Parents of Newborns, run by Baylor College of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of PACV administration on vaccine hesitancy (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.

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