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

Human Papillomavirus Clinical Trial

Official title:

Comparative Effectiveness of Interactive, Health Literacy Promoting Text Messages on HPV Vaccine Completion In Minority Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236273
• Other study ID #: AAAM3960
• Status: Completed
• Phase: N/A
• First received: September 7, 2014
• Last updated: January 23, 2018
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 956
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV vaccine series completion	receipt of 3 doses of HPV vaccine by 12 months after initiation	12 months
Secondary	Time between 1st and 2nd dose	Time elapsed in weeks between first and second dose	2 months
Secondary	Time between 1st and 3rd dose	Time elapsed (in months) between 1st and 3rd dose	6 months