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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Vaccine Information | No Intervention | Brief (47 second) animated informational video about vaccines recommended for all young adolescents. | |
| Top Concern Tailored Intervention | Experimental | 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). |
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| All Concerns Tailored Intervention | Experimental | 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". |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Top Concern Tailored Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after video intervention has been administered |
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Inclusion Criteria:
Exclusion Criteria:
Mothers or female guardians of children 11-14 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Gregory D Zimet, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36854366 | Derived | Srivastava T, Head KJ, O'Dell SM, Feemster KA, Panozzo CA, Zimet GD, Kornides ML. Characterizing U.S. mothers with high human papillomavirus vaccine intent yet unvaccinated adolescents. Prev Med. 2023 Apr;169:107472. doi: 10.1016/j.ypmed.2023.107472. Epub 2023 Feb 26. | |
| 32199723 | Derived | Panozzo CA, Head KJ, Kornides ML, Feemster KA, Zimet GD. Tailored Messages Addressing Human Papillomavirus Vaccination Concerns Improves Behavioral Intent Among Mothers: A Randomized Controlled Trial. J Adolesc Health. 2020 Aug;67(2):253-261. doi: 10.1016/j.jadohealth.2020.01.024. Epub 2020 Mar 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | General Vaccine Information | Brief (47 second) animated informational video about vaccines recommended for all young adolescents. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | General Vaccine Information | Brief (47 second) animated informational video about vaccines recommended for all young adolescents. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately after video intervention has been administered |
|
20 minutes
This study involved participants completing a 20 minute online survey. Therefore, there was zero risk for either mortality or serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | General Vaccine Information | Brief (47 second) animated informational video about vaccines recommended for all young adolescents. |
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A limitation of this trial is that the outcome is intention to vaccinate, rather than actual vaccination.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Zimet | Indiana University | 3172748812 | gzimet@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2018 | Dec 19, 2018 | Prot_SAP_000.pdf |
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Factorial Assignment
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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.
| All Concerns Tailored Intervention | Behavioral | 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. |
|
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Child's Sex: Female, Male | Count of Participants | Participants |
|
| Child's Age, Continuous | Mean | Standard Deviation | Years |
|
| OG002 | 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. |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 306 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 299 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 303 |
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