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

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ClinicalTrials.gov Identifier: NCT02697396
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
The City College of New York
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
HPV Vaccination Behavioral: Assessments Other: Text Message Reminder Other: No Text Messaging

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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: A Randomized Controlled Trial of a Social Marketing Campaign to Increase HPV Vaccination Among Mexican American Children
Actual Study Start Date : February 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Group/Cohort Intervention/treatment
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.
Behavioral: 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.

Other: 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.

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.
Behavioral: 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.

Other: No Text Messaging
Participants in this arm will receive no additional vaccination reminders.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All recruitment will be completed by the MSKCC recruiting RSA who will approach all those attending the VDS at the Mexican Consulate in NYC and who are exposed to the social marketing campaign.
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.

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): NCT02697396


Contacts
Contact: Abraham Aragones, MD, MS 646-888-8058
Contact: Francesca Gany, MD, MS 646-888-8054

Locations
United States, New York
Consulate General of Mexico in New York Recruiting
New York, New York, United States, 10016
Contact: Abraham Aragones, MD, MS    646-888-8058      
Contact: Francesca Gany, MD, MS    646-888-8054      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
The City College of New York
Investigators
Principal Investigator: Abraham Aragones, MD, MS Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02697396     History of Changes
Other Study ID Numbers: 16-069
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
Social Marketing Campaign
Mexican American Children
16-069

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs