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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209713
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 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 2021
Estimated Study Completion Date : June 2021

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 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 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. 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




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.



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.

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


Contacts
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Contact: Abraham Aragones, MD, MS 646-888-8058 aragonea@mskcc.org
Contact: Francesca Gany, MD, MS 646-888-8054

Locations
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United States, Illinois
Alivio Medical Center Recruiting
Chicago, Illinois, United States, 60608
Contact: Ester Corpuz    773-254-1400      
United States, Nevada
Research, Education and Access to Community Health (REACH) Recruiting
Las Vegas, Nevada, United States, 89101
Contact: Rebeca Aceves Zaragoza    702-477-2755      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Abraham Aragones, MD, MS    646-888-8058      
Contact: Francesca Gany, MD, MS    646-888-8054      
United States, Texas
The University of Texas at El Paso Recruiting
El Paso, Texas, United States, 79968
Contact: Eva Moya, PhD    915-747-8493      
Principal Investigator: Eva Moya, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Abraham Aragones, MD, MS Memorial Sloan Kettering Cancer Center
Additional Information:
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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: November 22, 2019
Last Verified: November 2019

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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