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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209713
Recruitment Status : Active, not recruiting
First Posted : July 6, 2017
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Parents Behavioral: HPV Vaccine Education Behavioral: Text Messaging Reminder Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 672 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Edtech-HPV: A Community Approach Using Education and Technology to Increase HPV Vaccination
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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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 Name: EdTech-HPV


Outcome Measures
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Primary Outcome Measures :
  1. Vaccination completion assessment rate [ Time Frame: 2 years ]
    Comparison rates of vaccination completion will be assessed by Fisher's exact test.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209713


Locations
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United States, Illinois
Alivio Medical Center
Chicago, Illinois, United States, 60608
United States, Nevada
Research, Education and Access to Community Health (REACH)
Las Vegas, Nevada, United States, 89101
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
The University of Texas at El Paso
El Paso, Texas, United States, 79968
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Francesca Gany, MD, MS Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03209713    
Other Study ID Numbers: 17-336
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Mexican
Mexican-American
17-336