NCT02697396

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Feb 2016Feb 2027

Study Start

First participant enrolled

February 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

11 years

First QC Date

February 24, 2016

Last Update Submit

March 2, 2026

Conditions

Keywords

Social Marketing CampaignMexican American Children16-069

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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: AssessmentsOther: 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.

Behavioral: AssessmentsOther: No Text Messaging

Interventions

AssessmentsBEHAVIORAL

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.

with text messaging reminder systemwithout 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.

with text messaging reminder system

Participants in this arm will receive no additional vaccination reminders.

without text messaging reminder system

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consulate General of Mexico in New York

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Francesca Gany, MD, MS

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 3, 2016

Study Start

February 1, 2016

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations