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Clinical Trials/NCT02697396
NCT02697396
Active, not recruiting
Not Applicable

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

Memorial Sloan Kettering Cancer Center1 site in 1 country181 target enrollmentFebruary 1, 2016

Overview

Phase
Not Applicable
Intervention
Assessments
Conditions
HPV Vaccination
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
181
Locations
1
Primary Endpoint
Number of participants who complete 3 doses of the HPV vaccine
Status
Active, not recruiting
Last Updated
last month

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2016
End Date
February 1, 2027
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: Assessments

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.

Intervention: Text Message Reminder

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.

Intervention: Assessments

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.

Intervention: No Text Messaging

Outcomes

Primary Outcomes

Number of participants who complete 3 doses of the HPV vaccine

Time Frame: 6 months

This study will determine the effect of a social marketing campaign on HPV vaccination targeting Mexican American parents or guardians of vaccine-eligible children comparing the campaign alone against the campaign plus text message reminders on the proportion of participants who complete 3 doses of the HPV vaccine for their youngest eligible child.

Study Sites (1)

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