Vaccine Refusal
Conditions
Keywords
HPV Vaccines, China
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.
Interventions
BEHAVIORALBroadened information about cancers
Caregivers receive information that HPV causes more than just cervical cancer.
BEHAVIORALInformation about STDs
Caregivers learn that HPV is an STD.
BEHAVIORALInformation about infectious disease
Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
BEHAVIORALRecommendation for children 12 years old
Caregivers are prompted to get their child vaccinated when the child is 12 years old.
BEHAVIORALRecommendation for children 18 years old
Caregivers are prompted to get their child vaccinated when the child is 18 years old.
BEHAVIORALStandard age information
Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.
BEHAVIORALCervical cancer
Caregivers are told that HPV causes cervical cancer.
BEHAVIORALBlank information about communicability
Caregivers are not given any information on how HPV is spread.
Sponsors
Shanghai Municipal Center for Disease Control and Prevention
National Institute of Allergy and Infectious Diseases (NIAID)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Parents of children 2-18 years old.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Sustained Willingness to Receive it | 3 years | 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. |
Countries
China
Participant flow
Recruitment details
Recruitment period: summer 2019 Recruitment locations: immunization clinics and schools in 40 townships in Shanghai, China
Participants by arm
| Arm | Count |
|---|---|
| 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.
Information about STDs: Caregivers learn that HPV is an STD.
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. | 79 |
| 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.
Information about STDs: Caregivers learn that HPV is an STD.
Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.
Cervical cancer: Caregivers are told that HPV causes cervical cancer. | 45 |
| 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.
Information about STDs: Caregivers learn that HPV is an STD.
Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.
Cervical cancer: Caregivers are told that HPV causes cervical cancer. | 52 |
| 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.
Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
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. | 51 |
| 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.
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.
Cervical cancer: Caregivers are told that HPV causes cervical cancer. | 48 |
| 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.
Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.
Cervical cancer: Caregivers are told that HPV causes cervical cancer. | 49 |
| 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.
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. | 49 |
| 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.
Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.
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. | 52 |
| 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.
Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.
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. | 53 |
| 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.
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.
Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations. | 58 |
| 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.
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.
Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old. | 57 |
| 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.
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.
Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old. | 51 |
| 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.
Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.
Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations. | 55 |
| 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.
Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.
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. | 52 |
| 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.
Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.
Information about infectious disease: Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old. | 56 |
| 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.
Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.
Standard age information: Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.
Blank information about communicability: Caregivers are not given any information on how HPV is spread. | 50 |
| 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.
Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.
Recommendation for children 12 years old: Caregivers are prompted to get their child vaccinated when the child is 12 years old.
Blank information about communicability: Caregivers are not given any information on how HPV is spread. | 48 |
| 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.
Broadened information about cancers: Caregivers receive information that HPV causes more than just cervical cancer.
Recommendation for children 18 years old: Caregivers are prompted to get their child vaccinated when the child is 18 years old.
Blank information about communicability: Caregivers are not given any information on how HPV is spread. | 48 |
| Total | 953 |
Baseline characteristics
| Characteristic | Cervical Cancer - STD - 12 Years Old (y.o.) | Cervical Cancer - Infectious - Standard | Cervical Cancer - Infectious - 12 y.o. | Cervical Cancer - Infectious - 18 y.o. | Cervical Cancer - Blank - Standard | Cervical Cancer - Blank - 12 y.o. | Cervical Cancer - Blank - 18 y.o. | Many Cancers - STD - Standard | Many Cancers - STD - 12 y.o. | Many Cancers - STD - 18 y.o. | Many Cancers - Infectious - Standard | Many Cancers - Infectious - 12 y.o. | Many Cancers - Infectious - 18 y.o. | Many Cancers - Blank - Standard | Many Cancers - Blank - 12 y.o. | Many Cancers - Blank - 18 y.o. | Cervical Cancer - Sexually Transmitted (STD) - Standard | Total | Cervical Cancer - STD - 18 y.o. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 38 years | 38 years | 35 years | 37.5 years | 39 years | 36 years | 37 years | 36 years | 37 years | 37 years | 37 years | 37 years | 37 years | 37 years | 38 years | 38 years | 39 years | 37 years | 39 years |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — |
| Region of Enrollment China | 45 participants | 51 participants | 48 participants | 49 participants | 49 participants | 52 participants | 53 participants | 58 participants | 57 participants | 51 participants | 55 participants | 52 participants | 56 participants | 50 participants | 48 participants | 48 participants | 79 participants | 953 participants | 52 participants |
| Sex: Female, Male Female | 34 Participants | 40 Participants | 37 Participants | 37 Participants | 40 Participants | 45 Participants | 46 Participants | 47 Participants | 44 Participants | 41 Participants | 43 Participants | 39 Participants | 52 Participants | 34 Participants | 40 Participants | 40 Participants | 61 Participants | 758 Participants | 38 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 11 Participants | 12 Participants | 9 Participants | 7 Participants | 7 Participants | 11 Participants | 13 Participants | 10 Participants | 12 Participants | 13 Participants | 4 Participants | 16 Participants | 8 Participants | 8 Participants | 18 Participants | 195 Participants | 14 Participants |
| Vaccinated at baseline | 4 Participants | 1 Participants | 4 Participants | 6 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 4 Participants | 53 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 45 | 0 / 52 | 0 / 51 | 0 / 48 | 0 / 49 | 0 / 49 | 0 / 52 | 0 / 53 | 0 / 58 | 0 / 57 | 0 / 51 | 0 / 55 | 0 / 52 | 0 / 56 | 0 / 50 | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 0 / 79 | 0 / 45 | 0 / 52 | 0 / 51 | 0 / 48 | 0 / 49 | 0 / 49 | 0 / 52 | 0 / 53 | 0 / 58 | 0 / 57 | 0 / 51 | 0 / 55 | 0 / 52 | 0 / 56 | 0 / 50 | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 79 | 0 / 45 | 0 / 52 | 0 / 51 | 0 / 48 | 0 / 49 | 0 / 49 | 0 / 52 | 0 / 53 | 0 / 58 | 0 / 57 | 0 / 51 | 0 / 55 | 0 / 52 | 0 / 56 | 0 / 50 | 0 / 48 | 0 / 48 |
Outcome results
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.
Time frame: same day as intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervical Cancer - Sexually Transmitted (STD) - Standard | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 46 Participants |
| Cervical Cancer - STD - 12 Years Old (y.o.) | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 31 Participants |
| Cervical Cancer - STD - 18 y.o. | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 29 Participants |
| Cervical Cancer - Infectious - Standard | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 21 Participants |
| Cervical Cancer - Infectious - 12 y.o. | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 28 Participants |
| Cervical Cancer - Infectious - 18 y.o. | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 26 Participants |
| Cervical Cancer - Blank - Standard | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 28 Participants |
| Cervical Cancer - Blank - 12 y.o. | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 23 Participants |
| Cervical Cancer - Blank - 18 y.o. | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 31 Participants |
| Many Cancers - STD - Standard | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 35 Participants |
| Many Cancers - STD - 12 y.o. | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 33 Participants |
| Many Cancers - STD - 18 y.o. | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 27 Participants |
| Many Cancers - Infectious - Standard | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 33 Participants |
| Many Cancers - Infectious - 12 y.o. | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 31 Participants |
| Many Cancers - Infectious - 18 y.o. | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 29 Participants |
| Many Cancers - Blank - Standard | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 22 Participants |
| Many Cancers - Blank - 12 y.o. | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 28 Participants |
| Many Cancers - Blank - 18 y.o. | To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it | 25 Participants |
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.
Time frame: 3 years
Population: This study was terminated early because of COVID-19, and data on the secondary outcome were not collected.