NCT04380623

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

2.3 years

First QC Date

May 5, 2020

Last Update Submit

September 6, 2021

Conditions

Human Papilloma VirusHPV-Related CarcinomaVaccine RefusalParentsProgram, Communication

Outcome Measures

Primary Outcomes (3)

  • Recruitment Rates

    pre-screened, % contacted, % unable to contact, % screened, % enrolled, # enrolled per month

    6 months

  • Retention Rates

    % completed baseline survey, % came to clinic visit (primary retention endpoint), % completed post-visit survey

    6 months

  • Data collection processes

    % ascertained post-visit HPV vaccine status, # minutes to complete surveys

    6 months

Secondary Outcomes (1)

  • HPV vaccine rates

    6 months

Study Arms (2)

Mobile Phone-Based Web-Page: HPV vaccine

EXPERIMENTAL

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.

Behavioral: Mobile Phone-Based Web-Page: HPV vaccine

Mobile Phone-Based Web-Page: Healthy Lifestyles

ACTIVE COMPARATOR

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.

Behavioral: Mobile Phone-Based Web-Page: HPV vaccine

Interventions

Mobile Phone-Based Web-Page: HPV vaccineBEHAVIORAL

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

Mobile Phone-Based Web-Page: HPV vaccineMobile Phone-Based Web-Page: Healthy Lifestyles

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents
  • 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
  • Own smartphone
  • Speak English
  • Have a clinic appointment scheduled within the coming month (AIM 1 Stage 2 \& AIM 2 only)
  • Did not participate in Aim 1 Stage 1 (AIM 1 Stage 2 only)
  • Did not participate in Aim 1 Stage 1 or Aim 1 Stage 2 (Aim 2 only)
  • Providers
  • Physicians, physician assistants, and nurse practitioners who deliver primary care to patients aged 11-18 (Aim 1 Stage 1)
  • 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)

You may not qualify if:

  • Parents
  • 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
  • Do not own a smart phone
  • Does not have an upcoming clinic visit (Aim 1 Stage 2 and Aim 2)
  • Providers
  • Providers: Physicians, nurse practitioners, and physician assistants who do not deliver primary care to pediatric patients aged 11-18 at Meharry and other clinics
  • Providers who do not provide the HPV vaccine.
  • Providers who do not participate in Aim 1 stage 1 (Aim 1 Stage 2 only)
  • Did not pilot study (Aim 2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208, United States

RECRUITING

MeSH Terms

Conditions

Vaccination RefusalCommunication

Condition Hierarchy (Ancestors)

Treatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 8, 2020

Study Start

February 15, 2021

Primary Completion

May 30, 2023

Study Completion

May 30, 2024

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)