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

Study Overview
=================
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.

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

Conditions
-----------------
Human Papillomavirus

Intervention / Treatment
-----------------
* Behavioral: Conventional text message reminder
* Behavioral: Enhanced text message reminders


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Text Message<br>Conventional text message reminder | Behavioral: Conventional text message reminder<br>* Receipt of conventional text message notifying when due for next dose<br>|
| Experimental: Enhanced reminders<br>Enhanced text message reminders | Behavioral: Enhanced text message reminders<br>* Receipt of enhanced text messages notifying when due for next dose coupled with educational information<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV vaccine series completion | receipt of 3 doses of HPV vaccine by 12 months after initiation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between 1st and 2nd dose | Time elapsed in weeks between first and second dose | 2 months | 
| Time between 1st and 3rd dose | Time elapsed (in months) between 1st and 3rd dose | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human papillomavirus, vaccination, text message, reminder