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| Name | Class |
|---|---|
| Real Prevention, LLC | INDUSTRY |
| Merck Institute for Therapeutic Research | UNKNOWN |
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The goal of this clinical trial is to evaluate the feasibility of intervention implementation in two clinics in rural KY, and its preliminary efficacy with regards to increasing vaccine confidence in a sample of vaccine hesitant parents.
Hypothesis: Parents will report increased vaccine confidence scores post-intervention.
Data from this study will provide preliminary data for a larger scale evaluation of the intervention.
Participants will be asked to complete surveys, view a web-based intervention and then visit with their child's healthcare provider.
Participants will be asked to complete a brief screening assessment to establish their eligibility for participation. Eligible participants will be asked to complete a consent form and be directed to the pre-test survey. Upon completion of the survey, the participants will be directed to the tailored intervention content, including the Parents' Stories videos. This step will be completed prior to interaction with the provider. During the provider-patient visit, the provider will deliver the elaborated prompt portion of the intervention to participating mothers. Mothers will receive a link to the post-test survey two weeks following their appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parents' Stories Web Application + Provider Elaborated Prompts | Experimental | Participating parents will be asked to navigate a web application that consists of (a) brief, 90-second narrative videos that encourage parent-provider communication about the vaccine and (b) personalized feedback to parents that is tailored to provide educational content in response to their concerns and be motivational in nature. Providers will provide elaborated prompts related to the vaccine when meeting with parents tailored to their concerns. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web Application | Behavioral | A web application for vaccine-hesitant parents and their teens with brief, 90-second narrative videos and tailored, motivational content |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HPV Vaccine Hesitancy Scale score | 9-item scale from Strongly Disagree (1) to Strongly Agree (5); scores range from 1-5, with higher scores indicating greater hesitancy | From pretest to posttest (up to two weeks) |
| Change Human Papillomavirus Knowledge Questionnaire score | 13-item scale with True / False / I don't know response options; scores range from 0-13 with higher scores indicating greater vaccine knowledge | From pretest to posttest (up to two weeks) |
| Change in intent to discuss HPV vaccine with provider | Answers include Very likely; Somewhat likely; Not too likely; Not likely at all; Not sure / do not know | From pretest to posttest (up to two weeks) |
| Change in HPV vaccine intent | 1 item adapted from NIS-TEEN survey. Answers include very likely; somewhat likely; not too likely; not likely at all; not sure / do not know | From pretest to posttest (up to two weeks) |
| Change in self-reported HPV vaccination and related provider recommendations | 4 items adapted from the NIS-TEEN survey. | from screening to posttest (up to two weeks) |
| Change in Reasons Not to Vaccinate score | 16 items adapted from NIS-TEEN survey; higher score indicates more obstacles to vaccination | Pretest only |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne E Ray, PhD | Contact | 859-218-4944 | anne.ray@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anne E Ray, PhD. | University of Kentucky | Principal Investigator |
| Aaron Kruse-Diehr, PhD | University of Kentucky | Study Chair |
| Michael Hecht, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
Data will be available to qualified researchers after the main findings are published in a peer-reviewed journal upon request. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers.
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| Provider Elaborated Prompts | Behavioral | A component for providers that suggests elaborated prompts to be used with parents that align with the content of the web application, are tailored to parent concerns, and are motivational in nature |
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| Real Prevention, LLC |
| Study Chair |