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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02236273
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Melissa Stockwell, Columbia University

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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Behavioral: Conventional text message reminder Behavioral: Enhanced text message reminders Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 956 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparative Effectiveness of Interactive, Health Literacy Promoting Text Messages on HPV Vaccine Completion In Minority Adolescents
Actual Study Start Date : December 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Arm Intervention/treatment
Experimental: Conventional Text Message
Conventional text message reminder
Behavioral: Conventional text message reminder
Receipt of conventional text message notifying when due for next dose

Experimental: Enhanced reminders
Enhanced text message reminders
Behavioral: Enhanced text message reminders
Receipt of enhanced text messages notifying when due for next dose coupled with educational information




Primary Outcome Measures :
  1. HPV vaccine series completion [ Time Frame: 12 months ]
    receipt of 3 doses of HPV vaccine by 12 months after initiation


Secondary Outcome Measures :
  1. Time between 1st and 2nd dose [ Time Frame: 2 months ]
    Time elapsed in weeks between first and second dose

  2. Time between 1st and 3rd dose [ Time Frame: 6 months ]
    Time elapsed (in months) between 1st and 3rd dose



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236273


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Melissa S Stockwell, MD MPH Columbia University

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Responsible Party: Melissa Stockwell, Assistant Professor of Pediatrics and Population and Family Health, Columbia University
ClinicalTrials.gov Identifier: NCT02236273    
Other Study ID Numbers: AAAM3960
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Melissa Stockwell, Columbia University:
Human papillomavirus
vaccination
text message
reminder
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs