Study Stopped
Due to COVID-19, we were unable to continue data collection in China.
Optimizing HPV Vaccine Introduction in Shanghai, China
2 other identifiers
interventional
1,021
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 28, 2019
CompletedFirst Submitted
Initial submission to the registry
May 30, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedResults Posted
Study results publicly available
January 13, 2020
CompletedJanuary 15, 2025
January 1, 2025
3 months
May 30, 2019
December 6, 2019
January 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Sustained Willingness to Receive it
3 years
Study Arms (18)
cervical cancer - sexually transmitted (STD) - standard
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.
cervical cancer - STD - 12 years old (y.o.)
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.
cervical cancer - STD - 18 y.o.
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cervical cancer. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.
cervical cancer - infectious - standard
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.
cervical cancer - infectious - 12 y.o.
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.
cervical cancer - infectious - 18 y.o.
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cervical cancer. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.
cervical cancer - blank - standard
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.
cervical cancer - blank - 12 y.o.
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.
cervical cancer - blank - 18 y.o.
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.
many cancers - STD - standard
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.
many cancers - STD - 12 y.o.
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.
many cancers - STD - 18 y.o.
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system. HPV is a sexually transmitted disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.
many cancers - infectious - standard
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.
many cancers - infectious - 12 y.o.
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.
many cancers - infectious - 18 y.o.
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system. HPV is an infectious disease. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.
many cancers - blank - standard
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.
many cancers - blank - 12 y.o.
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between grade school and middle school is a particularly good time to think about the HPV vaccine.
many cancers - blank - 18 y.o.
EXPERIMENTALThe Human Papilloma Virus (HPV) causes cancers all over the body, from the head to the reproductive system. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China. The transition between high school and college or work is a particularly good time to think about the HPV vaccine.
Interventions
Caregivers receive information that HPV causes more than just cervical cancer.
Caregivers learn that HPV is an STD.
Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
Caregivers are prompted to get their child vaccinated when the child is 12 years old.
Caregivers are prompted to get their child vaccinated when the child is 18 years old.
Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.
Caregivers are told that HPV causes cervical cancer.
Caregivers are not given any information on how HPV is spread.
Eligibility Criteria
You may qualify if:
- Parents of children 2-18 years old.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai CDC
Shanghai, 200336, China
Related 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.
PMID: 34996644RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Note: Due to the COVID-19 pandemic, collection of data on the secondary outcome was stopped. Accordingly, the grant associated with this clinical trial had a change in scope.
Results Point of Contact
- Title
- Abram Wagner
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Abram L Wagner, PhD, MPH
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
May 30, 2019
First Posted
June 4, 2019
Study Start
May 28, 2019
Primary Completion
August 31, 2019
Study Completion
August 31, 2019
Last Updated
January 15, 2025
Results First Posted
January 13, 2020
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Wave 1 (aim 1): data available end of 2019
- Access Criteria
- The data is freely and publicly available
The dataset will be uploaded to a public repository after each wave of data collection is complete.