Optimizing HPV Vaccine Introduction in Shanghai, China

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.

Study Overview

• Status: Terminated
• Conditions: Vaccine Refusal
• Intervention / Treatment: Behavioral: Information about STDs; Behavioral: Standard age information; Behavioral: Cervical cancer; Behavioral: Recommendation for children 12 years old; Behavioral: Recommendation for children 18 years old; Behavioral: Information about infectious disease; Behavioral: Blank information about communicability; Behavioral: Broadened information about cancers

• Study Type: Interventional
• Enrollment (Actual): 1021
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200336
    • Shanghai CDC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parents of children 2-18 years old.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

18

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cervical cancer - sexually transmitted (STD) - standard; The 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.	Behavioral: Information about STDs; Caregivers learn that HPV is an STD.; Behavioral: Standard age information; Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.; Behavioral: Cervical cancer; Caregivers are told that HPV causes cervical cancer.
Experimental: cervical cancer - STD - 12 years old (y.o.); The 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.	Behavioral: Information about STDs; Caregivers learn that HPV is an STD.; Behavioral: Cervical cancer; Caregivers are told that HPV causes cervical cancer.; Behavioral: Recommendation for children 12 years old; Caregivers are prompted to get their child vaccinated when the child is 12 years old.
Experimental: cervical cancer - STD - 18 y.o.; The 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.	Behavioral: Information about STDs; Caregivers learn that HPV is an STD.; Behavioral: Cervical cancer; Caregivers are told that HPV causes cervical cancer.; Behavioral: Recommendation for children 18 years old; Caregivers are prompted to get their child vaccinated when the child is 18 years old.
Experimental: cervical cancer - infectious - standard; The 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.	Behavioral: Standard age information; Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.; Behavioral: Cervical cancer; Caregivers are told that HPV causes cervical cancer.; Behavioral: Information about infectious disease; Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
Experimental: cervical cancer - infectious - 12 y.o.; The 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.	Behavioral: Cervical cancer; Caregivers are told that HPV causes cervical cancer.; Behavioral: Recommendation for children 12 years old; Caregivers are prompted to get their child vaccinated when the child is 12 years old.; Behavioral: Information about infectious disease; Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
Experimental: cervical cancer - infectious - 18 y.o.; The 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.	Behavioral: Cervical cancer; Caregivers are told that HPV causes cervical cancer.; Behavioral: Recommendation for children 18 years old; Caregivers are prompted to get their child vaccinated when the child is 18 years old.; Behavioral: Information about infectious disease; Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
Experimental: cervical cancer - blank - standard; The Human Papilloma Virus (HPV) causes cervical cancer. Currently, safe and effective HPV vaccines are available for women 9-45 years of age in China.	Behavioral: Standard age information; Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.; Behavioral: Cervical cancer; Caregivers are told that HPV causes cervical cancer.; Behavioral: Blank information about communicability; Caregivers are not given any information on how HPV is spread.
Experimental: cervical cancer - blank - 12 y.o.; The 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.	Behavioral: Cervical cancer; Caregivers are told that HPV causes cervical cancer.; Behavioral: Recommendation for children 12 years old; Caregivers are prompted to get their child vaccinated when the child is 12 years old.; Behavioral: Blank information about communicability; Caregivers are not given any information on how HPV is spread.
Experimental: cervical cancer - blank - 18 y.o.; The 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.	Behavioral: Cervical cancer; Caregivers are told that HPV causes cervical cancer.; Behavioral: Recommendation for children 18 years old; Caregivers are prompted to get their child vaccinated when the child is 18 years old.; Behavioral: Blank information about communicability; Caregivers are not given any information on how HPV is spread.
Experimental: many cancers - STD - standard; The 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.	Behavioral: Information about STDs; Caregivers learn that HPV is an STD.; Behavioral: Standard age information; Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.; Behavioral: Broadened information about cancers; Caregivers receive information that HPV causes more than just cervical cancer.
Experimental: many cancers - STD - 12 y.o.; The 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.	Behavioral: Information about STDs; Caregivers learn that HPV is an STD.; Behavioral: Recommendation for children 12 years old; Caregivers are prompted to get their child vaccinated when the child is 12 years old.; Behavioral: Broadened information about cancers; Caregivers receive information that HPV causes more than just cervical cancer.
Experimental: many cancers - STD - 18 y.o.; The 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.	Behavioral: Information about STDs; Caregivers learn that HPV is an STD.; Behavioral: Recommendation for children 18 years old; Caregivers are prompted to get their child vaccinated when the child is 18 years old.; Behavioral: Broadened information about cancers; Caregivers receive information that HPV causes more than just cervical cancer.
Experimental: many cancers - infectious - standard; The 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.	Behavioral: Standard age information; Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.; Behavioral: Information about infectious disease; Caregivers learn that HPV is infectious (but information that it is an STD is omitted).; Behavioral: Broadened information about cancers; Caregivers receive information that HPV causes more than just cervical cancer.
Experimental: many cancers - infectious - 12 y.o.; The 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.	Behavioral: Recommendation for children 12 years old; Caregivers are prompted to get their child vaccinated when the child is 12 years old.; Behavioral: Information about infectious disease; Caregivers learn that HPV is infectious (but information that it is an STD is omitted).; Behavioral: Broadened information about cancers; Caregivers receive information that HPV causes more than just cervical cancer.
Experimental: many cancers - infectious - 18 y.o.; The 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.	Behavioral: Recommendation for children 18 years old; Caregivers are prompted to get their child vaccinated when the child is 18 years old.; Behavioral: Information about infectious disease; Caregivers learn that HPV is infectious (but information that it is an STD is omitted).; Behavioral: Broadened information about cancers; Caregivers receive information that HPV causes more than just cervical cancer.
Experimental: many cancers - blank - standard; The 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.	Behavioral: Standard age information; Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.; Behavioral: Blank information about communicability; Caregivers are not given any information on how HPV is spread.; Behavioral: Broadened information about cancers; Caregivers receive information that HPV causes more than just cervical cancer.
Experimental: many cancers - blank - 12 y.o.; The 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.	Behavioral: Recommendation for children 12 years old; Caregivers are prompted to get their child vaccinated when the child is 12 years old.; Behavioral: Blank information about communicability; Caregivers are not given any information on how HPV is spread.; Behavioral: Broadened information about cancers; Caregivers receive information that HPV causes more than just cervical cancer.
Experimental: many cancers - blank - 18 y.o.; The 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.	Behavioral: Recommendation for children 18 years old; Caregivers are prompted to get their child vaccinated when the child is 18 years old.; Behavioral: Blank information about communicability; Caregivers are not given any information on how HPV is spread.; Behavioral: Broadened information about cancers; Caregivers receive information that HPV causes more than just cervical cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Shanghai Municipal Center for Disease Control and Prevention
• Investigators: Principal Investigator: Abram L Wagner, PhD, MPH, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: China; HPV Vaccines
• Other Study ID Numbers: HUM00155864; K01AI137123 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset will be uploaded to a public repository after each wave of data collection is complete.
• IPD Sharing Time Frame: Wave 1 (aim 1): data available end of 2019
• IPD Sharing Access Criteria: The data is freely and publicly available
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No