Optimizing HPV Vaccine Introduction in Shanghai, China

NCT ID: NCT03972813

Last Updated: 2025-01-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1021 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-28

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vaccine Refusal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

In this educational intervention, there are three dimensions of variability: cancer messaging, communicability messaging, and age messaging. For cancer messaging there are two possibilities: one message focused more on cervical cancer, one message on cancer in general. For communicability, one message will have information on sexual transmission, a second on infectiousness in general, and a third will have no information about communicability. For age, one will mention that the vaccine is available for 9-45 year olds, the second will mention that and additionally recommend children 11 years old to receive the vaccine, and the third will recommend children 18 years old to receive the vaccine.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Information about STDs

Intervention Type BEHAVIORAL

Caregivers learn that HPV is an STD.

Standard age information

Intervention Type BEHAVIORAL

Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.

Cervical cancer

Intervention Type BEHAVIORAL

Caregivers are told that HPV causes cervical cancer.

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.

Group Type EXPERIMENTAL

Information about STDs

Intervention Type BEHAVIORAL

Caregivers learn that HPV is an STD.

Recommendation for children 12 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 12 years old.

Cervical cancer

Intervention Type BEHAVIORAL

Caregivers are told that HPV causes cervical cancer.

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.

Group Type EXPERIMENTAL

Information about STDs

Intervention Type BEHAVIORAL

Caregivers learn that HPV is an STD.

Recommendation for children 18 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 18 years old.

Cervical cancer

Intervention Type BEHAVIORAL

Caregivers are told that HPV causes cervical cancer.

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.

Group Type EXPERIMENTAL

Information about infectious disease

Intervention Type BEHAVIORAL

Caregivers learn that HPV is infectious (but information that it is an STD is omitted).

Standard age information

Intervention Type BEHAVIORAL

Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.

Cervical cancer

Intervention Type BEHAVIORAL

Caregivers are told that HPV causes cervical cancer.

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.

Group Type EXPERIMENTAL

Information about infectious disease

Intervention Type BEHAVIORAL

Caregivers learn that HPV is infectious (but information that it is an STD is omitted).

Recommendation for children 12 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 12 years old.

Cervical cancer

Intervention Type BEHAVIORAL

Caregivers are told that HPV causes cervical cancer.

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.

Group Type EXPERIMENTAL

Information about infectious disease

Intervention Type BEHAVIORAL

Caregivers learn that HPV is infectious (but information that it is an STD is omitted).

Recommendation for children 18 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 18 years old.

Cervical cancer

Intervention Type BEHAVIORAL

Caregivers are told that HPV causes cervical cancer.

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.

Group Type EXPERIMENTAL

Standard age information

Intervention Type BEHAVIORAL

Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.

Cervical cancer

Intervention Type BEHAVIORAL

Caregivers are told that HPV causes cervical cancer.

Blank information about communicability

Intervention Type BEHAVIORAL

Caregivers are not given any information on how HPV is spread.

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.

Group Type EXPERIMENTAL

Recommendation for children 12 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 12 years old.

Cervical cancer

Intervention Type BEHAVIORAL

Caregivers are told that HPV causes cervical cancer.

Blank information about communicability

Intervention Type BEHAVIORAL

Caregivers are not given any information on how HPV is spread.

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.

Group Type EXPERIMENTAL

Recommendation for children 18 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 18 years old.

Cervical cancer

Intervention Type BEHAVIORAL

Caregivers are told that HPV causes cervical cancer.

Blank information about communicability

Intervention Type BEHAVIORAL

Caregivers are not given any information on how HPV is spread.

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.

Group Type EXPERIMENTAL

Broadened information about cancers

Intervention Type BEHAVIORAL

Caregivers receive information that HPV causes more than just cervical cancer.

Information about STDs

Intervention Type BEHAVIORAL

Caregivers learn that HPV is an STD.

Standard age information

Intervention Type BEHAVIORAL

Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.

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.

Group Type EXPERIMENTAL

Broadened information about cancers

Intervention Type BEHAVIORAL

Caregivers receive information that HPV causes more than just cervical cancer.

Information about STDs

Intervention Type BEHAVIORAL

Caregivers learn that HPV is an STD.

Recommendation for children 12 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 12 years old.

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.

Group Type EXPERIMENTAL

Broadened information about cancers

Intervention Type BEHAVIORAL

Caregivers receive information that HPV causes more than just cervical cancer.

Information about STDs

Intervention Type BEHAVIORAL

Caregivers learn that HPV is an STD.

Recommendation for children 18 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 18 years old.

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.

Group Type EXPERIMENTAL

Broadened information about cancers

Intervention Type BEHAVIORAL

Caregivers receive information that HPV causes more than just cervical cancer.

Information about infectious disease

Intervention Type BEHAVIORAL

Caregivers learn that HPV is infectious (but information that it is an STD is omitted).

Standard age information

Intervention Type BEHAVIORAL

Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.

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.

Group Type EXPERIMENTAL

Broadened information about cancers

Intervention Type BEHAVIORAL

Caregivers receive information that HPV causes more than just cervical cancer.

Information about infectious disease

Intervention Type BEHAVIORAL

Caregivers learn that HPV is infectious (but information that it is an STD is omitted).

Recommendation for children 12 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 12 years old.

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.

Group Type EXPERIMENTAL

Broadened information about cancers

Intervention Type BEHAVIORAL

Caregivers receive information that HPV causes more than just cervical cancer.

Information about infectious disease

Intervention Type BEHAVIORAL

Caregivers learn that HPV is infectious (but information that it is an STD is omitted).

Recommendation for children 18 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 18 years old.

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.

Group Type EXPERIMENTAL

Broadened information about cancers

Intervention Type BEHAVIORAL

Caregivers receive information that HPV causes more than just cervical cancer.

Standard age information

Intervention Type BEHAVIORAL

Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.

Blank information about communicability

Intervention Type BEHAVIORAL

Caregivers are not given any information on how HPV is spread.

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.

Group Type EXPERIMENTAL

Broadened information about cancers

Intervention Type BEHAVIORAL

Caregivers receive information that HPV causes more than just cervical cancer.

Recommendation for children 12 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 12 years old.

Blank information about communicability

Intervention Type BEHAVIORAL

Caregivers are not given any information on how HPV is spread.

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.

Group Type EXPERIMENTAL

Broadened information about cancers

Intervention Type BEHAVIORAL

Caregivers receive information that HPV causes more than just cervical cancer.

Recommendation for children 18 years old

Intervention Type BEHAVIORAL

Caregivers are prompted to get their child vaccinated when the child is 18 years old.

Blank information about communicability

Intervention Type BEHAVIORAL

Caregivers are not given any information on how HPV is spread.

Interventions

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Broadened information about cancers

Caregivers receive information that HPV causes more than just cervical cancer.

Intervention Type BEHAVIORAL

Information about STDs

Caregivers learn that HPV is an STD.

Intervention Type BEHAVIORAL

Information about infectious disease

Caregivers learn that HPV is infectious (but information that it is an STD is omitted).

Intervention Type BEHAVIORAL

Recommendation for children 12 years old

Caregivers are prompted to get their child vaccinated when the child is 12 years old.

Intervention Type BEHAVIORAL

Recommendation for children 18 years old

Caregivers are prompted to get their child vaccinated when the child is 18 years old.

Intervention Type BEHAVIORAL

Standard age information

Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.

Intervention Type BEHAVIORAL

Cervical cancer

Caregivers are told that HPV causes cervical cancer.

Intervention Type BEHAVIORAL

Blank information about communicability

Caregivers are not given any information on how HPV is spread.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Parents of children 2-18 years old.

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Municipal Center for Disease Control and Prevention

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Abram Wagner

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abram L Wagner, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Shanghai CDC

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 34996644 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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K01AI137123

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00155864

Identifier Type: -

Identifier Source: org_study_id

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