Vaccine RefusalNCT03972813
Optimizing HPV Vaccine Introduction in Shanghai, China
A study testing Broadened information about cancers, Information about STDs and Information about infectious disease in people with Vaccine Refusal, run by University of Michigan at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Refusal
- What is being tested?
- Broadened information about cancers, Information about STDs and Information about infectious disease
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,021 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2019to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Parents of children 2-18 years old.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Vaccine Refusal
- Being tested
- Broadened information about cancers, Information about STDs, Information about infectious disease, Recommendation for children 12 years old, Recommendation for children 18 years old
- Keywords
- HPV Vaccines, China
- Medical subject headings
- Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broadened information about cancersBehavioural
Caregivers receive information that HPV causes more than just cervical cancer.
Information about STDsBehavioural
Caregivers learn that HPV is an STD.
Information about infectious diseaseBehavioural
Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
Recommendation for children 12 years oldBehavioural
Caregivers are prompted to get their child vaccinated when the child is 12 years old.
Recommendation for children 18 years oldBehavioural
Caregivers are prompted to get their child vaccinated when the child is 18 years old.
Standard age informationBehavioural
Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.
Cervical cancerBehavioural
Caregivers are told that HPV causes cervical cancer.
Blank information about communicabilityBehavioural
Caregivers are not given any information on how HPV is spread.
| Study group | Role | What they receive |
|---|---|---|
| cervical cancer - sexually transmitted (STD) - standard | Experimental | 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. Receives: Behavioral: Information about STDs; Behavioral: Standard age information; Behavioral: Cervical cancer |
| cervical cancer - STD - 12 years old (y.o.) | Experimental | 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. Receives: Behavioral: Information about STDs; Behavioral: Recommendation for children 12 years old; Behavioral: Cervical cancer |
| cervical cancer - STD - 18 y.o. | Experimental | 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. Receives: Behavioral: Information about STDs; Behavioral: Recommendation for children 18 years old; Behavioral: Cervical cancer |
| cervical cancer - infectious - standard | Experimental | 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. Receives: Behavioral: Information about infectious disease; Behavioral: Standard age information; Behavioral: Cervical cancer |
| cervical cancer - infectious - 12 y.o. | Experimental | 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. Receives: Behavioral: Information about infectious disease; Behavioral: Recommendation for children 12 years old; Behavioral: Cervical cancer |
| cervical cancer - infectious - 18 y.o. | Experimental | 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. Receives: Behavioral: Information about infectious disease; Behavioral: Recommendation for children 18 years old; Behavioral: Cervical cancer |
| cervical cancer - blank - standard | Experimental | 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. Receives: Behavioral: Standard age information; Behavioral: Cervical cancer; Behavioral: Blank information about communicability |
| cervical cancer - blank - 12 y.o. | Experimental | 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. Receives: Behavioral: Recommendation for children 12 years old; Behavioral: Cervical cancer; Behavioral: Blank information about communicability |
| cervical cancer - blank - 18 y.o. | Experimental | 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. Receives: Behavioral: Recommendation for children 18 years old; Behavioral: Cervical cancer; Behavioral: Blank information about communicability |
| many cancers - STD - standard | Experimental | 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. Receives: Behavioral: Broadened information about cancers; Behavioral: Information about STDs; Behavioral: Standard age information |
| many cancers - STD - 12 y.o. | Experimental | 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. Receives: Behavioral: Broadened information about cancers; Behavioral: Information about STDs; Behavioral: Recommendation for children 12 years old |
| many cancers - STD - 18 y.o. | Experimental | 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. Receives: Behavioral: Broadened information about cancers; Behavioral: Information about STDs; Behavioral: Recommendation for children 18 years old |
| many cancers - infectious - standard | Experimental | 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. Receives: Behavioral: Broadened information about cancers; Behavioral: Information about infectious disease; Behavioral: Standard age information |
| many cancers - infectious - 12 y.o. | Experimental | 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. Receives: Behavioral: Broadened information about cancers; Behavioral: Information about infectious disease; Behavioral: Recommendation for children 12 years old |
| many cancers - infectious - 18 y.o. | Experimental | 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. Receives: Behavioral: Broadened information about cancers; Behavioral: Information about infectious disease; Behavioral: Recommendation for children 18 years old |
| many cancers - blank - standard | Experimental | 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. Receives: Behavioral: Broadened information about cancers; Behavioral: Standard age information; Behavioral: Blank information about communicability |
| many cancers - blank - 12 y.o. | Experimental | 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. Receives: Behavioral: Broadened information about cancers; Behavioral: Recommendation for children 12 years old; Behavioral: Blank information about communicability |
| many cancers - blank - 18 y.o. | Experimental | 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. Receives: Behavioral: Broadened information about cancers; Behavioral: Recommendation for children 18 years old; Behavioral: Blank information about communicability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start28 May 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Why it stopped: Due to COVID-19, we were unable to continue data collection in China.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine RefusalStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,021 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Center for Disease Control and Prevention, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Abram Wagner, University of Michigan
- Investigators
- Abram L Wagner, PhD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972813
- Sponsor's protocol ID
- HUM00155864
- Other IDs
- K01AI137123
- Status last verified
- Jan 2025
- First submitted
- 30 May 2019
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset will be uploaded to a public repository after each wave of data collection is complete.
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.
PubMed 34996644
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing HPV Vaccine Introduction in Shanghai, China
- ClinicalTrials.gov ID
- NCT03972813
- Acronym / sponsor ID
- HUM00155864
- Conditions
- Vaccine Refusal
- Keywords
- HPV Vaccines, China
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19, we were unable to continue data collection in China.
- Enrolment
- 1,021 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Shanghai Municipal Center for Disease Control and Prevention, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 28 May 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 18
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| cervical cancer - sexually transmitted (STD) - standard | Experimental | Behavioral: Information about STDs, Behavioral: Standard age information, Behavioral: Cervical cancerThe 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.) | Experimental | Behavioral: Information about STDs, Behavioral: Recommendation for children 12 years old, Behavioral: Cervical cancerThe 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. | Experimental | Behavioral: Information about STDs, Behavioral: Recommendation for children 18 years old, Behavioral: Cervical cancerThe 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 | Experimental | Behavioral: Information about infectious disease, Behavioral: Standard age information, Behavioral: Cervical cancerThe 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. | Experimental | Behavioral: Information about infectious disease, Behavioral: Recommendation for children 12 years old, Behavioral: Cervical cancerThe 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. | Experimental | Behavioral: Information about infectious disease, Behavioral: Recommendation for children 18 years old, Behavioral: Cervical cancerThe 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 | Experimental | Behavioral: Standard age information, Behavioral: Cervical cancer, Behavioral: Blank information about communicabilityThe 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. | Experimental | Behavioral: Recommendation for children 12 years old, Behavioral: Cervical cancer, Behavioral: Blank information about communicabilityThe 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. | Experimental | Behavioral: Recommendation for children 18 years old, Behavioral: Cervical cancer, Behavioral: Blank information about communicabilityThe 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 | Experimental | Behavioral: Broadened information about cancers, Behavioral: Information about STDs, Behavioral: Standard age informationThe 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. | Experimental | Behavioral: Broadened information about cancers, Behavioral: Information about STDs, Behavioral: Recommendation for children 12 years oldThe 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. | Experimental | Behavioral: Broadened information about cancers, Behavioral: Information about STDs, Behavioral: Recommendation for children 18 years oldThe 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 | Experimental | Behavioral: Broadened information about cancers, Behavioral: Information about infectious disease, Behavioral: Standard age informationThe 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. | Experimental | Behavioral: Broadened information about cancers, Behavioral: Information about infectious disease, Behavioral: Recommendation for children 12 years oldThe 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. | Experimental | Behavioral: Broadened information about cancers, Behavioral: Information about infectious disease, Behavioral: Recommendation for children 18 years oldThe 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 | Experimental | Behavioral: Broadened information about cancers, Behavioral: Standard age information, Behavioral: Blank information about communicabilityThe 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. | Experimental | Behavioral: Broadened information about cancers, Behavioral: Recommendation for children 12 years old, Behavioral: Blank information about communicabilityThe 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. | Experimental | Behavioral: Broadened information about cancers, Behavioral: Recommendation for children 18 years old, Behavioral: Blank information about communicabilityThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents of children 2-18 years old.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Broadened information about cancersCaregivers receive information that HPV causes more than just cervical cancer. | Behavioural | many cancers - STD - 12 y.o., many cancers - STD - 18 y.o., many cancers - STD - standard, many cancers - blank - 12 y.o., many cancers - blank - 18 y.o., many cancers - blank - standard, many cancers - infectious - 12 y.o., many cancers - infectious - 18 y.o., many cancers - infectious - standard |
| Information about STDsCaregivers learn that HPV is an STD. | Behavioural | cervical cancer - STD - 12 years old (y.o.), cervical cancer - STD - 18 y.o., cervical cancer - sexually transmitted (STD) - standard, many cancers - STD - 12 y.o., many cancers - STD - 18 y.o., many cancers - STD - standard |
| Information about infectious diseaseCaregivers learn that HPV is infectious (but information that it is an STD is omitted). | Behavioural | cervical cancer - infectious - 12 y.o., cervical cancer - infectious - 18 y.o., cervical cancer - infectious - standard, many cancers - infectious - 12 y.o., many cancers - infectious - 18 y.o., many cancers - infectious - standard |
| Recommendation for children 12 years oldCaregivers are prompted to get their child vaccinated when the child is 12 years old. | Behavioural | cervical cancer - STD - 12 years old (y.o.), cervical cancer - blank - 12 y.o., cervical cancer - infectious - 12 y.o., many cancers - STD - 12 y.o., many cancers - blank - 12 y.o., many cancers - infectious - 12 y.o. |
| Recommendation for children 18 years oldCaregivers are prompted to get their child vaccinated when the child is 18 years old. | Behavioural | cervical cancer - STD - 18 y.o., cervical cancer - blank - 18 y.o., cervical cancer - infectious - 18 y.o., many cancers - STD - 18 y.o., many cancers - blank - 18 y.o., many cancers - infectious - 18 y.o. |
| Standard age informationCaregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations. | Behavioural | cervical cancer - blank - standard, cervical cancer - infectious - standard, cervical cancer - sexually transmitted (STD) - standard, many cancers - STD - standard, many cancers - blank - standard, many cancers - infectious - standard |
| Cervical cancerCaregivers are told that HPV causes cervical cancer. | Behavioural | cervical cancer - STD - 12 years old (y.o.), cervical cancer - STD - 18 y.o., cervical cancer - blank - 12 y.o., cervical cancer - blank - 18 y.o., cervical cancer - blank - standard, cervical cancer - infectious - 12 y.o., cervical cancer - infectious - 18 y.o., cervical cancer - infectious - standard, cervical cancer - sexually transmitted (STD) - standard |
| Blank information about communicabilityCaregivers are not given any information on how HPV is spread. | Behavioural | cervical cancer - blank - 12 y.o., cervical cancer - blank - 18 y.o., cervical cancer - blank - standard, many cancers - blank - 12 y.o., many cancers - blank - 18 y.o., many cancers - blank - standard |
Primary outcome
To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it
Time frame: same day as intervention
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.
1 secondary outcome
To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Sustained Willingness to Receive it
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34996644Huang 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.
- Individual participant dataSharing planned: Yes. The dataset will be uploaded to a public repository after each wave of data collection is complete.
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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.
Abram L Wagner, PhD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broadened information about cancers, Information about STDs and Information about infectious disease in people with Vaccine Refusal, run by University of Michigan at 1 site in China.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it (time frame: same day as intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03972813, which also lists 1 linked publication.
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 15 Jan 2025.