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

NCT ID: NCT03209713

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

672 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Parental Education

Participants will receive parental education on HPV vaccine and the vaccine's benefits.

Group Type ACTIVE_COMPARATOR

HPV Vaccine Education

Intervention Type BEHAVIORAL

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.

Parental Education + Text Messaging

Participants will receive parental education on HPV vaccine and the vaccine's benefits plus text messaging reminder.

Group Type EXPERIMENTAL

HPV Vaccine Education

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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EdTech-HPV

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hackensack Meridian Health

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesca Gany, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Alivio Medical Center

Chicago, Illinois, United States

Site Status

Research, Education and Access to Community Health (REACH)

Las Vegas, Nevada, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

The University of Texas at El Paso

El Paso, Texas, United States

Site Status

Countries

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United States

References

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Aragones A, Zamore C, Moya EM, Cordero JI, Gany F, Bruno DM. The Impact of Restrictive Policies on Mexican Immigrant Parents and Their Children's Access to Health Care. Health Equity. 2021 Sep 14;5(1):612-618. doi: 10.1089/heq.2020.0111. eCollection 2021.

Reference Type DERIVED
PMID: 34909528 (View on PubMed)

Related Links

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http://mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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17-336

Identifier Type: -

Identifier Source: org_study_id

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