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

HPV Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02697396
• Other study ID #: 16-069
• Status: Active, not recruiting
• Start date: February 2016
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 181
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HPV Vaccination

Intervention

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

Locations

Country	Name	City	State
United States	Consulate General of Mexico in New York	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Hackensack Meridian Health, The City College of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who complete 3 doses of the HPV vaccine	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.	6 months

External Links

•   Memorial Sloan Kettering Cancer Center