Trial of a Social Marketing Campaign to Increase HPV Vaccination Among Mexican American Children

NCT ID: NCT02697396

Last Updated: 2025-03-04

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

Total Enrollment

181 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2026-02-28

Brief Summary

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This project aims to raise awareness and improve HPV vaccination rates among children of Mexican American parents through the implementation of a tailored social marketing campaign which includes text messaging reminders.

Detailed Description

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This randomized controlled trial (RCT) will assess a social marketing campaign on HPV vaccination with and without a text messaging reminder system targeting Mexican Americans in a community-based setting, at the Ventanilla De Salud (Health Window, VDS) program and the Consulate on Wheels-Ventanilla De Salud Movil (Mobile Health Window, VDS on wheels) program of the Mexican Consulate. Investigators plan on recruiting 200 Mexican American parents of children ages 9 through 17. Every VDS attendee eligible for the study and who is willing to consent to participate will be invited to the study. Consenting participants will be randomized to either a follow-up reminder text messaging system or to the group which will not receive the text messaging reminders. All participants, regardless of text messaging arm, will evaluate the campaign and investigators will assess adherence to the HPV vaccine for the total sample.

Conditions

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HPV Vaccination

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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with text messaging reminder system

Participants randomly assigned to the text messaging group will receive a text message reminding them of their child's vaccination eligibility once a week, starting one week after exposure to the social marketing campaign and time of consent.

Assessments

Intervention Type BEHAVIORAL

All participants, after consent, will be asked to complete the study contact form and then complete a baseline assessment with the RSA. This baseline assessment will take approximately 5 minutes.

Text Message Reminder

Intervention Type OTHER

Participants randomly assigned to the text messaging group will receive a text message reminding them of their child's vaccination eligibility once a week, starting one week after exposure to the social marketing campaign and time of consent.

without text messaging reminder system

Participants in this arm will receive no additional vaccination reminders. However, the study staff will ask and record if the participant's pediatrician provides appointment reminder cards, emails and/or calls prior to each scheduled vaccination as captured in the Outcomes Survey.

Assessments

Intervention Type BEHAVIORAL

All participants, after consent, will be asked to complete the study contact form and then complete a baseline assessment with the RSA. This baseline assessment will take approximately 5 minutes.

No Text Messaging

Intervention Type OTHER

Participants in this arm will receive no additional vaccination reminders.

Interventions

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Assessments

All participants, after consent, will be asked to complete the study contact form and then complete a baseline assessment with the RSA. This baseline assessment will take approximately 5 minutes.

Intervention Type BEHAVIORAL

Text Message Reminder

Participants randomly assigned to the text messaging group will receive a text message reminding them of their child's vaccination eligibility once a week, starting one week after exposure to the social marketing campaign and time of consent.

Intervention Type OTHER

No Text Messaging

Participants in this arm will receive no additional vaccination reminders.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Born in Mexico or born in the U.S. but self-describes as Mexican-American Spanish is her/his primary language
* Has a minimum of one child between the ages of 9 and 17 who has not received the HPV vaccine and who lives with the parent/guardian as per self report
* Self-identifies as the child's main caregiver
* Currently owns a cell phone, uses text messaging services and is willing to accept text messages for this study

Exclusion Criteria

* Will not be in the NYC area for the duration of the study period (6-9 months)
* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The City College of New York

OTHER

Sponsor Role collaborator

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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Consulate General of Mexico in New York

New York, New York, United States

Site Status

Countries

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United States

References

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Aragones A, Gany F, Kaplan A, Bruno D. An opportunity to increase human papillomavirus vaccination rates: Change the guidelines. Hum Vaccin Immunother. 2022 Nov 30;18(6):2136444. doi: 10.1080/21645515.2022.2136444. Epub 2022 Oct 25.

Reference Type DERIVED
PMID: 36282533 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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16-069

Identifier Type: -

Identifier Source: org_study_id

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