HPV Vaccination
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALWeb Application
A web application for vaccine-hesitant parents and their teens with brief, 90-second narrative videos and tailored, motivational content
BEHAVIORALProvider Elaborated Prompts
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
Sponsors
Anne E Ray
Real Prevention, LLC
Merck Institute for Therapeutic Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* status as a mother or female guardian of an 11-17-year-old adolescent * status as a U.S. resident * self-reported ability to read English * self-reported HPV vaccine hesitant using established methodology
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HPV Vaccine Hesitancy Scale score | From pretest to posttest (up to two weeks) | 9-item scale from Strongly Disagree (1) to Strongly Agree (5); scores range from 1-5, with higher scores indicating greater hesitancy |
| Change Human Papillomavirus Knowledge Questionnaire score | From pretest to posttest (up to two weeks) | 13-item scale with True / False / I don't know response options; scores range from 0-13 with higher scores indicating greater vaccine knowledge |
| Change in intent to discuss HPV vaccine with provider | From pretest to posttest (up to two weeks) | Answers include Very likely; Somewhat likely; Not too likely; Not likely at all; Not sure / do not know |
| Change in HPV vaccine intent | From pretest to posttest (up to two weeks) | 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 |
| Change in self-reported HPV vaccination and related provider recommendations | from screening to posttest (up to two weeks) | 4 items adapted from the NIS-TEEN survey. |
| Change in Reasons Not to Vaccinate score | Pretest only | 16 items adapted from NIS-TEEN survey; higher score indicates more obstacles to vaccination |
Countries
United States
Contacts
CONTACTAnne E Ray, PhD
PRINCIPAL_INVESTIGATORAnne E Ray, PhD.
University of Kentucky
STUDY_CHAIRAaron Kruse-Diehr, PhD
University of Kentucky
STUDY_CHAIRMichael Hecht, PhD
Real Prevention, LLC
Outcome results
None listed