A Tailored, Health Communication Intervention for HPV Vaccine Hesitant Families
NCT ID: NCT04380623
Last Updated: 2021-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
244 participants
INTERVENTIONAL
2021-02-15
2024-05-30
Brief Summary
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Detailed Description
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Aim 1. To develop a tailored, health communication intervention targeting HPV-VH parents prior to clinic visits. The tailored intervention will be delivered to VH parents via mobile phones. Investigators will draft initial content based on the Theory of Reasoned Action and Health Belief Model, previous VH research,14 and preliminary data. Then semi-structured interviews will be conducted with 25-30 VH parents who previously declined the HPV vaccine and 10 physicians to elicit feedback on draft content. Qualitative data will be collected and analyzed iteratively, informing successive modifications to the intervention to cover a range of potential concerns for VH parents, enhance message relevance, and refine the intervention delivery process. Next, investigators will work with MMC Pediatrics to develop and refine the study protocol. Investigators will pre-test and get feedback on the protocol from 16 VH parents and 3 physicians to maximize acceptance and feasibility.
Aim 2. Conduct a pilot study of the intervention and study protocol to demonstrate feasibility for the future full-scale randomized control trial (RCT). Based on Aim 1, investigators will conduct a small, pilot RCT with 70 VH parents with scheduled clinic visits. Feasibility indicators are recruitment rates, retention rates, and ability to ascertain patients' post-visit HPV vaccine status in the clinical record. VHealth software will be used to extract information from the EHR to identify potentially eligible patients with a previous HPV vaccine refusal and to determine the whether an HPV vaccine dose was received during the scheduled visit.
Aim 3. Examine acceptability of the intervention and protocol among parents and providers. Parents participating in the pilot study will complete a post-visit survey to measure acceptability of the intervention and protocol, provider trust/rapport, and satisfaction with provider-patient communication. In addition, investigators will conduct semi-structured debriefing interviews with a subset of 20-30 parents and 3 providers to gather qualitative data about their experiences (e.g., unforeseen problems and barriers) and their perceptions of acceptability of the intervention and protocol (e.g., ease of use, content, graphics). The findings will be used identify needs for any additional modifications to the intervention and protocol prior to the RCT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Mobile Phone-Based Web-Page: HPV vaccine
Parents who have already declined the HPV vaccine for their adolescent will receive pre-visit, tailored education information on the HPV vaccine via a text message with a website link.
Mobile Phone-Based Web-Page: HPV vaccine
Website to be accessed via mobile phone to deliver tailored educational material
Mobile Phone-Based Web-Page: Healthy Lifestyles
Parents who have already declined the HPV vaccine for their adolescent will receive pre-visit education information on an unrelated topic (e.g., healthy eating and physical activity) via a text message with a website link.
Mobile Phone-Based Web-Page: HPV vaccine
Website to be accessed via mobile phone to deliver tailored educational material
Interventions
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Mobile Phone-Based Web-Page: HPV vaccine
Website to be accessed via mobile phone to deliver tailored educational material
Eligibility Criteria
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Inclusion Criteria
1. Parents of patients of MMC Pediatrics aged 11-18
2. Refused HPV vaccination in the past two years
3. Have not received any doses of HPV vaccine
4. Own smartphone
5. Speak English
6. Have a clinic appointment scheduled within the coming month (AIM 1 Stage 2 \& AIM 2 only)
7. Did not participate in Aim 1 Stage 1 (AIM 1 Stage 2 only)
8. Did not participate in Aim 1 Stage 1 or Aim 1 Stage 2 (Aim 2 only)
Providers
1. Physicians, physician assistants, and nurse practitioners who deliver primary care to patients aged 11-18 (Aim 1 Stage 1)
2. Physicians, physician assistants, and nurse practitioners who deliver primary care to patients aged 11-18 and the intervention at Meharry Medical College. (Aim 1 Stage 2, Aim 2)
Exclusion Criteria
1. Parents with vaccinated patients or never been offered the vaccine in MMC pediatrics aged 11-18
2. Unvaccinated yet never refused the vaccine
3. Do not speak English
4. Do not own a smart phone
5. Does not have an upcoming clinic visit (Aim 1 Stage 2 and Aim 2)
Providers
1. Providers: Physicians, nurse practitioners, and physician assistants who do not deliver primary care to pediatric patients aged 11-18 at Meharry and other clinics
2. Providers who do not provide the HPV vaccine.
3. Providers who do not participate in Aim 1 stage 1 (Aim 1 Stage 2 only)
4. Did not pilot study (Aim 2)
18 Years
ALL
Yes
Sponsors
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Meharry Medical College
OTHER
Responsible Party
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Locations
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Meharry Medical College
Nashville, Tennessee, United States
Countries
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Facility Contacts
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Other Identifiers
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18-12-890
Identifier Type: -
Identifier Source: org_study_id
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