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A Tailored, Health Communication Intervention for HPV Vaccine Hesitant Families

A Tailored, Health Communication Intervention for HPV Vaccine Hesitant Families

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04380623
Enrollment
244
Registered
2020-05-08
Start date
2021-02-15
Completion date
2024-05-30
Last updated
2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV-Related Carcinoma, Human Papilloma Virus, Parents, Program, Communication, Vaccine Refusal

Brief summary

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.

Detailed description

The goal of this K01 application is to develop and pilot test an individually tailored, pre-visit health communication intervention targeting HPV-VH parents. The partnering clinic is 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. 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.

Interventions

BEHAVIORALMobile Phone-Based Web-Page: HPV vaccine

Website to be accessed via mobile phone to deliver tailored educational material

Sponsors

Meharry Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Aims 1 and 2 Only Inclusion Criteria Parents 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

Parents 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)

Design outcomes

Primary

MeasureTime frameDescription
Recruitment Rates6 monthspre-screened, % contacted, % unable to contact, % screened, % enrolled, # enrolled per month
Retention Rates6 months% completed baseline survey, % came to clinic visit (primary retention endpoint), % completed post-visit survey
Data collection processes6 months% ascertained post-visit HPV vaccine status, # minutes to complete surveys

Secondary

MeasureTime frameDescription
HPV vaccine rates6 months\# vaccinated post-intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026