NCT02236273

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
956

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

July 29, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

September 7, 2014

Results QC Date

July 16, 2024

Last Update Submit

July 9, 2025

Conditions

Human Papillomavirus

Keywords

Human papillomavirusvaccinationtext messagereminder

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Completed HPV Vaccine Series

    receipt of 3 doses of HPV vaccine by 12 months after initiation

    12 months

Secondary Outcomes (2)

  • Time Between 1st and 2nd Dose

    12 months

  • Time Between 1st and 3rd Dose

    12 months

Study Arms (2)

Conventional Text Message

EXPERIMENTAL

Conventional text message reminder

Behavioral: Conventional text message reminder

Enhanced reminders

EXPERIMENTAL

Enhanced text message reminders

Behavioral: Enhanced text message reminders

Interventions

Conventional text message reminderBEHAVIORAL

Receipt of conventional text message notifying when due for next dose

Conventional Text Message
Enhanced text message remindersBEHAVIORAL

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

Enhanced reminders

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 34958306DERIVED

Results Point of Contact

Title
Melissa Stockwell
Organization
Columbia University
mss2112@cumc.columbia.edu
2123425732

Study Officials

  • Melissa S Stockwell, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics and Population and Family Health

Study Record Dates

First Submitted

September 7, 2014

First Posted

September 10, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 29, 2025

Results First Posted

July 29, 2025

Record last verified: 2025-07

Locations

US(1)