Optimizing HPV Vaccine Introduction in Shanghai, China

Vaccine Refusal Clinical Trial

Official title:

Optimizing HPV Vaccine Introduction in Shanghai, China

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03972813
• Other study ID #: HUM00155864
• Secondary ID: K01AI137123
• Status: Terminated
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Within low, middle, and upper income countries, low vaccine coverage results from both obstacles to vaccine access and low confidence in vaccine programs. Thus, it is critical to determine how best to enhance trust in vaccines as increasing numbers of vaccines are recommended for use. Even though the context accompanying the initial roll-out of a vaccine can have a large impact on people's perceptions of the vaccine and the corresponding disease, it is not clear how to best introduce a vaccine to increase public confidence and enhance uptake. The US roll-out of the human papillomavirus (HPV) vaccine framed HPV as a sexually transmitted infection, which proved to be an impediment to efforts to increase vaccine uptake >10 years after its introduction. This study will use an educational experiment, where parents of children will be exposed to information about the HPV vaccination in different ways. Parents will be introduced to the HPV vaccine through different scenarios with varying emphases (i.e., age at vaccination, types of transmission, type of cancer prevention). The aim will be to determine how the framing of the HPV vaccination across several dimensions affects short-term willingness to receive it.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1021
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Parents of children 2-18 years old.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Vaccine Refusal

Intervention

Behavioral:
• Broadened information about cancers
Caregivers receive information that HPV causes more than just cervical cancer.
• Information about STDs
Caregivers learn that HPV is an STD.
• Information about infectious disease
Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
• Recommendation for children 12 years old
Caregivers are prompted to get their child vaccinated when the child is 12 years old.
• Recommendation for children 18 years old
Caregivers are prompted to get their child vaccinated when the child is 18 years old.
• Standard age information
Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.
• Cervical cancer
Caregivers are told that HPV causes cervical cancer.
• Blank information about communicability
Caregivers are not given any information on how HPV is spread.

Locations

Country	Name	City	State
China	Shanghai CDC	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Allergy and Infectious Diseases (NIAID), Shanghai Municipal Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

References & Publications (1)

Huang Z, Ji M, Ren J, Sun X, Boulton ML, Zikmund-Fisher BJ, Wagner AL. Effect of the framing of HPV vaccination on parents' willingness to accept an HPV vaccine. Vaccine. 2022 Feb 7;40(6):897-903. doi: 10.1016/j.vaccine.2021.12.051. Epub 2022 Jan 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it	Immediately after the experimental component, parents will respond to the question "If you had a daughter, how willing would you be to give your daughter an HPV vaccine at 12 years of age?" This will be assessed on a 5-point scale from "not at all willing" (1) to "very willing" (5). The proportion of parents who select "somewhat" (4) or "very willing" (5) will be tallied as the primary outcome measure.	same day as intervention
Secondary	To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Sustained Willingness to Receive it	Three years after the experimental component, parents will respond to the question "If you had a daughter, how willing would you be to give your daughter an HPV vaccine at 12 years of age?" This will be assessed on a 5-point scale from "not at all willing" (1) to "very willing" (5). The proportion of parents who select "somewhat" (4) or "very willing" (5) will be tallied as the primary outcome measure.	3 years