Edtech-HPV: A Community Approach Using Education and Technology to Increase HPV Vaccination (Edtech-HPV)

April 16, 2024 updated by: Memorial Sloan Kettering Cancer Center

This study is a two-arm randomized controlled trial, implemented to assess the effectiveness of a community-based educational program with and without a text messaging reminder system, in increasing the rate of HPV vaccination completion among children of Mexican Americans.

The investigator's have extended the duration that participants are followed in assessing their child's uptake of the HPV vaccine to coincide with the COVID-19 related clinic closures and/or allow flexibility for participants who decide to delay their child's vaccination for fear of exposure to the COVID-19 infection.

A survey will also assess the participants concerns regarding the impact COVID-19 has had in their daily life, such as financial insecurity, food access, housing insecurity and among other most common concerns during this unprecedented time. Additional navigation, referrals and interviewer notes will also be captured. Participants may be called by site or MSK staff to complete study surveys and will be informed verbally or by a mailed letter.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

672

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60608
        • Alivio Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Research, Education and Access to Community Health (REACH)
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Texas
      • El Paso, Texas, United States, 79968
        • The University of Texas at El Paso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Born in Mexico or born in U.S. but self-describes as Mexican-American
  • Spanish is his or her primary language
  • Has a minimum of one child between the ages of 11 and 17 who has not initiated or completed the HPV vaccine seriest (as per the age-recommended timeframe)
  • Self-identifies as the child's main caregiver
  • Currently owns a cell phone and uses text messaging services and is willing to accept text messages for this study
  • 21 to 84 years old

Exclusion Criteria:

  • Presence of a serious psychiatric or cognitive impairment likely to preclude meaningful informed consent and adherence to the protocol per the consenting professional's judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Parental Education
Participants will receive parental education on HPV vaccine and the vaccine's benefits.
Behavioral: HPV Vaccine Education
A one on one twenty-minute parental educational program (in-person or over the phone) providing facts about HPV, HPV-related cancers, and the HPV vaccine.
Experimental: Parental Education + Text Messaging
Participants will receive parental education on HPV vaccine and the vaccine's benefits plus text messaging reminder.
Behavioral: HPV Vaccine Education
A one on one twenty-minute parental educational program (in-person or over the phone) providing facts about HPV, HPV-related cancers, and the HPV vaccine.
Behavioral: Text Messaging Reminder
Participants will receive a text message reminding them of their child's vaccination eligibility once a week, starting one week after participating in the education session (in-person or over the phone). All participants randomized to the text message reminder arm will receive a welcome text message from the automated web-based text messaging service, Mosio, within 72 hours from registration. One week after receiving the welcome text message, they will receive the first weekly text messages reminding them of their child's eligibility for the first dose HPV vaccine. These weekly reminders will occur until uptake of the first dose of the vaccine is reported (through self-report outcome survey completion or submission of the HPV vaccination card/child's official immunization card) or for up to 12 weeks
Other Names:
  • EdTech-HPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccination completion assessment rate
Time Frame: 2 years
Comparison rates of vaccination completion will be assessed by Fisher's exact test.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Hackensack Meridian Health

Investigators

  • Principal Investigator: Francesca Gany, MD, MS, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2017

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

July 3, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17-336

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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