- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02697396
Trial of a Social Marketing Campaign to Increase HPV Vaccination Among Mexican American Children
April 16, 2024 updated by: Memorial Sloan Kettering Cancer Center
A Randomized Controlled Trial of a Social Marketing Campaign to Increase HPV Vaccination Among Mexican American Children
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
Enrollment (Actual)
181
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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New York, New York, United States, 10016
- Consulate General of Mexico in New York
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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.
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.
|
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.
Participants in this arm will receive no additional vaccination reminders.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Francesca Gany, MD, MS, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
February 24, 2016
First Submitted That Met QC Criteria
February 26, 2016
First Posted (Estimated)
March 3, 2016
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 16-069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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