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| ID | Type | Description | Link |
|---|---|---|---|
| 3P30CA023108-38S4 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Norris Cotton Cancer Center | OTHER |
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This project involves a social media campaign to increase parent's knowledge and acceptance of the HPV (human papillomavirus) vaccine. The current vaccine protects against nine types of HPV, including seven that are known to cause cancer. The Centers for Disease Control and Prevention (CDC) estimates that the current HPV vaccine could prevent 90% of cancer cases caused by HPV, including cases of cervical cancer, oropharyngeal (mouth and throat) cancer, anal cancer, and others. About 150 and 104 cases of HPV-associated cancers are diagnosed each year in New Hampshire and Vermont, respectively-many of which could be prevented through vaccination. Currently, only 49.8% of New Hampshire adolescents and 44.3% of Vermont adolescents were not up-to-date for HPV vaccination as of 2016. This social media campaign is testing a set of campaign messages with parents locally and nationally to see which messages are most effective in improving their knowledge and acceptance of the vaccine. A study survey link will monitor the number of people reached and will measure parental intention to get their children vaccinated against HPV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV Messaging | Experimental | Subjects are randomized to receive one of five messages on one of the four themes about HPV vaccination. |
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| Control Message | Other | Subjects are randomized to receive one of five messages about electronic cigarettes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Media Message about HPV and HPV vaccine | Other | Messages educate parents with facts about HPV vaccination. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Attitudes About HPV Vaccine | Change in Attitudes about HPV vaccine: Pre to post test comparison of summated 9 items measured on a 7-point scale of HPV vaccine attitudes. Scores range from a minimum of 9 to a maximum of 63. Higher scores indicated more positive attitudes toward HPV vaccination. Change was calculated from two time points, the later time point(<1 hour post messaging intervention) minus value at baseline. | Post test completed < 1 hour post messaging intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral Intention to Vaccinate Their Child With HPV Vaccine | A sub-group of parents of 9-14 year old children who had not been vaccinated were asked on pre- and post-test: How likely is it that she/he will receive the HPV vaccine in the next 12 months? Responses range form 1 (very likely) to 5 (not very likely). HPV vaccination behavioral intent change scores were calculated by subtracting pre- and post- test values. It is a negative-value scale, in which smaller values indicate more positive attitude change after exposure to the viewed message. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ardis L Olson, MD | Trustees of Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| Label | URL |
|---|---|
| HPV cancer diagnosis rates | View source |
| HPV vaccination rates | View source |
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Eligible, consented participants completed a pre-test survey prior to assignment to an arm.
1713 prospective participants responded to a social media or MTurk posting about the study between 12/12/18 to 04/15/19. 39 declined to consent. Of the remaining 1674 participants: 631 had no child and were deemed ineligible,.1043 people were eligible and consented to be in the study. Of that, 45 dropped before random assignment. As such, 998 people were eligible, provided a consent, and completed a baseline survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | HPV Messaging | 834 Subjects were randomized to receive an experimental message about HPV vaccination. |
| FG001 | Control Messaging | 164 Subjects received a control message. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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1,713 participants initially recruited but 631 ineligible because no child leaving 1,043 eligible. Of eligibles 998 completed baseline survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | HPV Messaging | 834 Subjects are randomized to receive one of five messages on one of the five themes about HPV vaccination.(165-167/group) Social Media Message about HPV and HPV vaccine: Messages educate parents with facts about HPV vaccination. |
| BG001 | Control Message |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Years of age of parent as reported by study participant who identifies them as a parent on survey. |
| 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 | Change in Attitudes About HPV Vaccine | Change in Attitudes about HPV vaccine: Pre to post test comparison of summated 9 items measured on a 7-point scale of HPV vaccine attitudes. Scores range from a minimum of 9 to a maximum of 63. Higher scores indicated more positive attitudes toward HPV vaccination. Change was calculated from two time points, the later time point(<1 hour post messaging intervention) minus value at baseline. | 1 participant in the experimental group and 2 participants in the control group withdrew from the study and are not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Post test completed < 1 hour post messaging intervention |
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Adverse events not anticipated over the < 1 hour of the study for a participant which only collects survey data about views of HPV vaccine
Adverse events not collected
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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 | HPV Messaging | Subjects are randomized to receive one of five messages on one of the four themes about HPV vaccination. Social Media Message about HPV and HPV vaccine: Messages educate parents with facts about HPV vaccination. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ardis Olson | Norris Cotton Cancer Center | 603-643-2385 | Ardis.Olson@dartmouth.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 | Feb 27, 2019 | Sep 17, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Phase 3 | Feb 27, 2019 | Sep 17, 2020 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Phase 2 | Dec 7, 2018 | Sep 17, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Participants are not aware of which arm of social messaging they are receiving and whether they are receiving the control message or not
| Social media message about risk of electronic cigarettes. | Other | Messages educate parents with facts about electronic cigarettes. This is an attention control group without outcomes obtained. |
|
| Ore test immediately before viewing message and post- test immediately after viewing message. Approximately one hour. |
164 Subjects are randomized to receive one of five messages about electronic cigarettes. Social media message about risk of electronic cigarettes.: Messages educate parents with facts about electronic cigarettes. This is an attention control group without outcomes obtained. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Prior knowledge of HPV | Count of Participants | Participants |
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| HPV Vaccine in prevents Cervical Cancer | This is a single question with the results reported as the answer from 1 to 5 on perceived effective of vaccine in preventing the cancer. Lower scores show a higher perception of it being effective. The full title is used without abbreviation. | Mean | Standard Deviation | units on a scale |
|
| HPV Vaccine in prevents Throat Cancer | 5 point scale from strongly disagree to strongly agree. This is a single question with the results reported as the answer from 1 to 5 on perceived effective of vaccine in preventing the cancer. Lower scores show a higher perception of it being effective. The full title is used without abbreviation. | Mean | Standard Deviation | units on a scale |
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| OG001 |
| Control Messaging |
164 Subjects received a control message not about HPV vaccination. |
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|
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| Secondary | Behavioral Intention to Vaccinate Their Child With HPV Vaccine | A sub-group of parents of 9-14 year old children who had not been vaccinated were asked on pre- and post-test: How likely is it that she/he will receive the HPV vaccine in the next 12 months? Responses range form 1 (very likely) to 5 (not very likely). HPV vaccination behavioral intent change scores were calculated by subtracting pre- and post- test values. It is a negative-value scale, in which smaller values indicate more positive attitude change after exposure to the viewed message. | A sub-group of parents of 9-14 year old children who had not been vaccinated were asked on pre- and post-test: How likely is it that she/he will receive the HPV vaccine in the next 12 months? Responses range form 1 (very likely) to 5 (not very likely). | Posted | Mean | Standard Deviation | units on a scale | Ore test immediately before viewing message and post- test immediately after viewing message. Approximately one hour. |
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| 0 |
| 0 |
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| EG001 | Control Message | Subjects are randomized to receive one of five messages about electronic cigarettes. Social media message about risk of electronic cigarettes.: Messages educate parents with facts about electronic cigarettes. This is an attention control group without outcomes obtained. | 0 | 0 | 0 | 0 | 0 | 0 |
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