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

Parents Clinical Trial

— Edtech-HPV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03209713
• Other study ID #: 17-336
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 28, 2017
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 672
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parents

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Alivio Medical Center	Chicago	Illinois
United States	The University of Texas at El Paso	El Paso	Texas
United States	Research, Education and Access to Community Health (REACH)	Las Vegas	Nevada
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccination completion assessment rate	Comparison rates of vaccination completion will be assessed by Fisher's exact test.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center