NCT03209713

Brief Summary

This study is a two-arm randomized controlled trial, implemented to assess the effectiveness of a community-based educational program with and without a text messaging reminder system, in increasing the rate of HPV vaccination completion among children of Mexican Americans. The investigator's have extended the duration that participants are followed in assessing their child's uptake of the HPV vaccine to coincide with the COVID-19 related clinic closures and/or allow flexibility for participants who decide to delay their child's vaccination for fear of exposure to the COVID-19 infection. A survey will also assess the participants concerns regarding the impact COVID-19 has had in their daily life, such as financial insecurity, food access, housing insecurity and among other most common concerns during this unprecedented time. Additional navigation, referrals and interviewer notes will also be captured. Participants may be called by site or MSK staff to complete study surveys and will be informed verbally or by a mailed letter.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
672

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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 Progress90%
Jun 2017Jun 2027

Study Start

First participant enrolled

June 28, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

9.9 years

First QC Date

July 3, 2017

Last Update Submit

April 17, 2026

Conditions

Keywords

MexicanMexican-American17-336

Outcome Measures

Primary Outcomes (1)

  • Vaccination completion assessment rate

    Comparison rates of vaccination completion will be assessed by Fisher's exact test.

    2 years

Study Arms (2)

Parental Education

ACTIVE COMPARATOR

Participants will receive parental education on HPV vaccine and the vaccine's benefits.

Behavioral: HPV Vaccine Education

Parental Education + Text Messaging

EXPERIMENTAL

Participants will receive parental education on HPV vaccine and the vaccine's benefits plus text messaging reminder.

Behavioral: HPV Vaccine EducationBehavioral: Text Messaging Reminder

Interventions

A one on one twenty-minute parental educational program (in-person or over the phone) providing facts about HPV, HPV-related cancers, and the HPV vaccine.

Parental EducationParental Education + Text Messaging

Participants will receive a text message reminding them of their child's vaccination eligibility once a week, starting one week after participating in the education session (in-person or over the phone). All participants randomized to the text message reminder arm will receive a welcome text message from the automated web-based text messaging service, Mosio, within 72 hours from registration. One week after receiving the welcome text message, they will receive the first weekly text messages reminding them of their child's eligibility for the first dose HPV vaccine. These weekly reminders will occur until uptake of the first dose of the vaccine is reported (through self-report outcome survey completion or submission of the HPV vaccination card/child's official immunization card) or for up to 12 weeks

Also known as: EdTech-HPV
Parental Education + Text Messaging

Eligibility Criteria

Age21 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Born in Mexico or born in U.S. but self-describes as Mexican-American
  • Spanish is his or her primary language
  • Has a minimum of one child between the ages of 11 and 17 who has not initiated or completed the HPV vaccine seriest (as per the age-recommended timeframe)
  • Self-identifies as the child's main caregiver
  • Currently owns a cell phone and uses text messaging services and is willing to accept text messages for this study
  • to 84 years old

You may not qualify if:

  • 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 (4)

Alivio Medical Center

Chicago, Illinois, 60608, United States

Location

Research, Education and Access to Community Health (REACH)

Las Vegas, Nevada, 89101, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

The University of Texas at El Paso

El Paso, Texas, 79968, United States

Location

Related Publications (1)

  • Aragones A, Zamore C, Moya EM, Cordero JI, Gany F, Bruno DM. The Impact of Restrictive Policies on Mexican Immigrant Parents and Their Children's Access to Health Care. Health Equity. 2021 Sep 14;5(1):612-618. doi: 10.1089/heq.2020.0111. eCollection 2021.

Related Links

Study Officials

  • Francesca Gany, MD, MS

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 6, 2017

Study Start

June 28, 2017

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations