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.
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
- Conditions the study is for
- Evaluating Impact of PACV on Vaccine Hesitancy Among Parents of Newborns
- What is being tested?
- PACV survey
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- 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:
- 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.
Exclusion criteria:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Placebo survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Prevalence of vaccine hesitancy
We assessed the proportion of vaccine-hesitant parents
Measured: 6 months
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.
- First posted30 Jun 2020
- Study startOct 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluating Impact of PACV on Vaccine Hesitancy Among Parents of NewbornsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital
- Responsible party
- Principal investigator, Julie Boom, Baylor College of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of PACV Administration on Vaccine Hesitancy: a Randomized Control Trial, Houston, TX
- ClinicalTrials.gov ID
- NCT04450940
- Acronym / sponsor ID
- H33255
- Keywords
- Parental Attitudes about Childhood Vaccines, vaccine hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,705 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital
- Study start
- Oct 2013 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Exclusion criteria:
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PACV | Experimental | Behavioral: PACV surveyThe 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. |
| Placebo | Sham comparator | Behavioral: Placebo surveyThe placebo arm received a placebo survey on general childhood health topics at baseline. All participants received the PACV at 6-month follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACV survey | Behavioural | PACV |
| Placebo survey | Behavioural | Placebo |
Primary outcome
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
2 secondary outcomes
Prevalence of vaccine hesitancy
Time frame: 6 months
Summarize characteristics of vaccine-hesitant parents
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.