The human papillomavirus (HPV) causes 90% of cervical cancers and is implicated in multiple other cancers. The HPV vaccine can prevent the vast majority of these cancers, but it is underused in adolescents, especially among those within vaccine hesitant (VH) parents. The proposed research is to develop and pilot test a tailored, health communication intervention aimed to increase HPV vaccination among VH parents. The proposed research is innovative because no evidence-based health communication interventions target HPV VH parents, and we will use stakeholder engagement throughout this study. The research will add knowledge on how tailored education provided before a doctor's visit can play a role in improving HPV vaccination rates among underserved, VH parents.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Prevention
- Masking: Double (Participant, Care Provider)
- Study Primary Completion Date: May 30, 2023
The goal of this K01 application is to develop and pilot test an individually tailored, pre-visit health communication intervention targeting HPV-VH parents. We will partner with the Meharry Medical College Pediatric Group (MMC Pediatrics), a safety-net clinic serving primarily publicly-insured and uninsured patients. The study has three specific aims.
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. We will draft initial content based on the Theory of Reasoned Action and Health Belief Model, previous VH research,14 and my preliminary data. We will then conduct semi-structured interviews 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, we will work with MMC Pediatrics to develop and refine the study protocol. We 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, we 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, we 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.
- Behavioral: Mobile Phone-Based Web-Page: HPV vaccine
- Website to be accessed via mobile phone to deliver tailored educational material
Arms, Groups and Cohorts
- Experimental: 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.
- Active Comparator: 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.
Clinical Trial Outcome Measures
- Recruitment Rates
- Time Frame: 6 months
- pre-screened, % contacted, % unable to contact, % screened, % enrolled, # enrolled per month
- Retention Rates
- Time Frame: 6 months
- % completed baseline survey, % came to clinic visit (primary retention endpoint), % completed post-visit survey
- Data collection processes
- Time Frame: 6 months
- % ascertained post-visit HPV vaccine status, # minutes to complete surveys
- HPV vaccine rates
- Time Frame: 6 months
- # vaccinated post-intervention
Participating in This Clinical Trial
Aim 1 Stage 1: (A) VH parents: Parents with unvaccinated children who are patients in MMC Pediatrics aged 11-18, refused HPV vaccine in past two years, speak English, own smartphone; (B) Providers: physicians, physician assistants, and nurse practitioners who deliver primary care to patients aged 11-18.
Aim 1 Stage 2: (A) Parents of patients of MMC Pediatrics aged 11-18, refused HPV vaccination in the past two years, have not received any doses of HPV vaccine, have a clinic appointment scheduled within the coming month, speak English, own smartphone, and did not participate in Aim 1 Stage 1.
Aim 2: (A) Parents/guardians of adolescent patients of MMC Pediatrics aged 11-18, refused HPV vaccination in the past two years, have not received any doses of HPV vaccine, have a clinic appointment scheduled in coming month, speak English, own smartphone, and did not participate in Aim 1; and (B) MMC pediatric providers participating in the pilot.
Aim 3: We will not be recruiting in Aim 3.
Aim 1 Stage 1: (A) Parents with vaccinated patients or never been offered the vaccine in MMC pediatrics aged 11-18, unvaccinated yet never refused the vaccine, do not speak English, and do not own a smart phone; (B) Providers who do not deliver primary care to patients aged 11-18.
Aim 1 Stage 2: Parents with vaccinated patients or who have never been offered the vaccine in MMC pediatrics aged 11-18, unvaccinated yet never refused the vaccine, do not speak English, participated in Aim 1 Stage 1; do not own a smart phone; does not have upcoming monthly clinic appointment for child.
Aim 2: (A) Parents/guardians of adolescent patients of MMC Pediatrics aged 11-18 who have vaccinated or not been offered the vaccine, do not have a clinic appointment scheduled in coming month, does not speak English, does not own smartphone, and participated in Aim 1; and (B) providers not participating in pilot study
Aim 3: N/A
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Meharry Medical College
- Provider of Information About this Clinical Study
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