Attitude to Health, Human Papilloma Virus Vaccines
Conditions
Brief summary
The purpose of this study is to investigate mother's attitudes about vaccinating their 11-14 year old children against the human papillomavirus (HPV). Among mothers who do not plan to vaccinate their child, the investigators will assess the influence of brief videos tailored to mothers' questions and concerns. Mothers will be randomized to one of three arms: 1. General video message about vaccination; 2. General message plus a brief video addressing the mother's primary concern; or 3. General message plus videos address all of mother-indicated concerns. The outcome of interest is intention to vaccinate. Our hypothesis is that the tailored videos will lead to increased intention to vaccinate.
Detailed description
Attitudes will be assessed through a Web-based survey administered by Survey Sampling International (SSI). The projected sample size is approximately 3,500, comprising mothers or female guardians of at least one child aged 11-14 who live in the United States. The survey will take no more than 20 minutes to complete. Mothers who indicate that they do not plan to vaccinate their children in the next year will be randomized to view brief videos tailored to their questions or concerns about HPV vaccination. The outcome of interest is intention to vaccinate. Mothers who have vaccinated their child or intend to vaccinate their child will be asked a separate set of questions relevant to this information. Mothers who indicate that they do not intend to vaccinate their child against HPV will be asked about their questions or concerns regarding HPV vaccination (from a pre-populated list of common concerns). Mothers will be randomized to one of three arms: 1. A general information video; 2. The general video plus a video addressing their top concern; or 3. The general video plus one or more videos addressing all of their concerns. Each video is less than 50 seconds in length.
Interventions
BEHAVIORALTop Concern Tailored Intervention
General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.
BEHAVIORALAll Concerns Tailored Intervention
General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Intervention videos delivered via anonymous online surveys through Survey Sampling International. Randomization to condition is built into the online survey. Participants will not know to which condition they will be randomized. Investigators are blinded by virtue of the built in randomization and anonymity of the survey.
Intervention model description
Factorial Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Lives in one of 26 US states with lower rates of HPV vaccination (New Jersey, Virginia, West Virginia, Alabama, Florida, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, Indiana, Minnesota, Ohio, Arkansas, Louisiana, New Mexico, Oklahoma, Kansas, Missouri, Montana, South Dakota, Utah, Wyoming, Idaho, Texas, Iowa) * Mother or female legal guardian of at least one child aged 11-14 years * Able to read and understand English * Target child must not have received any doses of HPV vaccine * The mother/respondent must indicate that she is not sure that she will vaccinate the target child in the next year.
Exclusion criteria
* Under 18 years of age * Not a mother or female legal guardian of at least one child ages 11-14 years * Not living in the United States or in one of the above designated states within the U.S. * Not able to understand or read English * Target child has already received at least 1 dose of HPV vaccine * The mother/respondent indicates (before the intervention) that she definitely intends to vaccinate the target child with HPV vaccine in the next year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intention to Vaccinate Against HPV in the Next 12 Months | Immediately after video intervention has been administered | Each parent will be asked to respond to this question. The response will be scaled from 1-10 in terms of parental intent regarding vaccination, with higher scores meaning greater parental intent to vaccinate children. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| General Vaccine Information Brief (47 second) animated informational video about vaccines recommended for all young adolescents. | 306 |
| Top Concern Tailored Intervention Intervention includes the General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns: 1. I need more information about the vaccine; 2. My child is too young; 3. I am concerned about the long-term health effects or safety of the vaccine; 4. My child's health care provider did not recommend it or said my child could wait; 5. The vaccine is not required for school; 6. Other / none of the above. For those indicating #6, they will receive the same video as those indicating #1 (need more information).
Top Concern Tailored Intervention: General Vaccine Information video plus a brief (\< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns. | 299 |
| All Concerns Tailored Intervention Intervention includes the General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns: 1. I need more information about the vaccine; 2. My child is too young; 3. I am concerned about the long-term health effects or safety of the vaccine; 4. My child's health care provider did not recommend it or said my child could wait; 5. The vaccine is not required for school; 6. Other / none of the above.
All Concerns Tailored Intervention: General Vaccine Information video plus one or more brief (\< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns. | 303 |
| Total | 908 |
Baseline characteristics
| Characteristic | General Vaccine Information | Top Concern Tailored Intervention | All Concerns Tailored Intervention | Total |
|---|---|---|---|---|
| Age, Customized 21-25 years old | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized 25-30 years old | 15 Participants | 13 Participants | 12 Participants | 40 Participants |
| Age, Customized 31-35 years old | 72 Participants | 64 Participants | 55 Participants | 191 Participants |
| Age, Customized 36-40 years old | 84 Participants | 72 Participants | 67 Participants | 223 Participants |
| Age, Customized 41-45 years old | 63 Participants | 75 Participants | 70 Participants | 208 Participants |
| Age, Customized 46-50 years old | 39 Participants | 38 Participants | 41 Participants | 118 Participants |
| Age, Customized 51-55 years old | 16 Participants | 16 Participants | 23 Participants | 55 Participants |
| Age, Customized 56-60 years old | 5 Participants | 5 Participants | 11 Participants | 21 Participants |
| Age, Customized 61-65 years old | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Age, Customized 66-70 years old | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Age, Customized 70-75 years old | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Child's Age, Continuous | 12.28 Years STANDARD_DEVIATION 1.12 | 12.33 Years STANDARD_DEVIATION 1.15 | 12.60 Years STANDARD_DEVIATION 1.15 | 12.40 Years STANDARD_DEVIATION 1.15 |
| Child's Sex: Female, Male Females | 153 Participants | 152 Participants | 155 Participants | 460 Participants |
| Child's Sex: Female, Male Males | 153 Participants | 147 Participants | 148 Participants | 448 Participants |
| Race/Ethnicity, Customized Hispanic | 30 Participants | 25 Participants | 13 Participants | 68 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 31 Participants | 16 Participants | 20 Participants | 67 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 28 Participants | 33 Participants | 37 Participants | 98 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 217 Participants | 225 Participants | 233 Participants | 675 Participants |
| Sex: Female, Male Female Female | 306 Participants | 299 Participants | 303 Participants | 908 Participants |
| Sex: Female, Male Female Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 306 | 0 / 299 | 0 / 303 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Intention to Vaccinate Against HPV in the Next 12 Months
Each parent will be asked to respond to this question. The response will be scaled from 1-10 in terms of parental intent regarding vaccination, with higher scores meaning greater parental intent to vaccinate children.
Time frame: Immediately after video intervention has been administered
| Arm | Measure | Value (MEAN) |
|---|---|---|
| General Vaccine Information | Intention to Vaccinate Against HPV in the Next 12 Months | 3.49 score on a scale |
| Top Concern Tailored Intervention | Intention to Vaccinate Against HPV in the Next 12 Months | 3.87 score on a scale |
| All Concerns Tailored Intervention | Intention to Vaccinate Against HPV in the Next 12 Months | 4.16 score on a scale |
p-value: <0.02ANOVA
p-value: =0.07ANOVA
Comparison: Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05p-value: <0.01ANOVA