Interactive, Health Literacy Promoting Text Messages and HPV Vaccine Completion In Minority Adolescents

NCT ID: NCT02236273

Last Updated: 2025-07-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

956 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-12-31

Brief Summary

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Emerging communication technologies, such as text messaging offer low-cost, scalable opportunities to improve health literacy and promote healthy behaviors, such as vaccination. While the investigators reported the success of text message vaccine reminders, effects were limited by their untailored approach. The trans-theoretical model of behavior change supports tailoring interventions to an individual's stage of decision-making. Human papillomavirus (HPV) is the most prevalent sexually transmitted virus in the U.S. and can lead to genital warts, and cervical, anal and penile cancer. The three-dose vaccine is 90-100% efficacious. Minorities are at greatest risk for such cancers but have low HPV vaccine completion rates. Limited health literacy regarding the vaccine can affect series completion. The investigators will compare the effects of enhancing text message vaccination reminders with interactive, vaccine health literacy-promoting information tailored to vaccine decision making-stage on HPV vaccine series completion. The effects of these messages represent a new paradigm in interactive health communications.

Detailed Description

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Conditions

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Human Papillomavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Conventional Text Message

Conventional text message reminder

Group Type EXPERIMENTAL

Conventional text message reminder

Intervention Type BEHAVIORAL

Receipt of conventional text message notifying when due for next dose

Enhanced reminders

Enhanced text message reminders

Group Type EXPERIMENTAL

Enhanced text message reminders

Intervention Type BEHAVIORAL

Receipt of enhanced text messages notifying when due for next dose coupled with educational information

Interventions

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Conventional text message reminder

Receipt of conventional text message notifying when due for next dose

Intervention Type BEHAVIORAL

Enhanced text message reminders

Receipt of enhanced text messages notifying when due for next dose coupled with educational information

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Parenting adult of adolescent age 11-17 years
* Adolescent received 1st dose of HPV at a study site within the last 2 weeks.
* Eligible parent's cell phone has text message capability

Exclusion Criteria

* Language other than English or Spanish only
* Parent already in the study
* Intends to move away from the New York City area in \<12 months
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Melissa Stockwell

Assistant Professor of Pediatrics and Population and Family Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa S Stockwell, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

References

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Wynn CS, Catallozzi M, Kolff CA, Holleran S, Meyer D, Ramakrishnan R, Stockwell MS. Personalized Reminders for Immunization Using Short Messaging Systems to Improve Human Papillomavirus Vaccination Series Completion: Parallel-Group Randomized Trial. JMIR Mhealth Uhealth. 2021 Dec 27;9(12):e26356. doi: 10.2196/26356.

Reference Type DERIVED
PMID: 34958306 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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AAAM3960

Identifier Type: -

Identifier Source: org_study_id

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