Clinical trial NCT06704308: Parents' HPV Stories
Official title: Development and Preliminary Evaluation of a Multilevel Intervention to Increase HPV Vaccine Confidence Among Parents of Youth in Rural KY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HPV Vaccination
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Real Prevention, LLC
name: Merck Institute for Therapeutic Research
First posted: 2024-11-26
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Change in HPV Vaccine Hesitancy Scale score
timeFrame: From pretest to posttest (up to two weeks)
measure: Change Human Papillomavirus Knowledge Questionnaire score
timeFrame: From pretest to posttest (up to two weeks)
measure: Change in intent to discuss HPV vaccine with provider
timeFrame: From pretest to posttest (up to two weeks)
measure: Change in HPV vaccine intent
timeFrame: From pretest to posttest (up to two weeks)
measure: Change in self-reported HPV vaccination and related provider recommendations
timeFrame: from screening to posttest (up to two weeks)
measure: Change in Reasons Not to Vaccinate score
timeFrame: Pretest only
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Anne E Ray, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Aaron Kruse-Diehr, PhD
role: STUDY_CHAIR
affiliation: Real Prevention, LLC
name: Michael Hecht, PhD
role: STUDY_CHAIR
References: