Skip to main content
OpenTrials
Completed

NCT Number: NCT01806714

Text Reminders to Immunize in a Managed Care Organization

The purpose of the study is to evaluate the effectiveness of a managed care-based HPV vaccination reminder/recall system using a randomized controlled trial (RCT) across diverse practices and patient populations. The trial will measure the effectiveness of text messaging reminder/recall on (a) improving initiation and (b) completion rate of the HPV vaccine series; (c) decreasing the time between vaccine doses; and (d) improving rates of preventive visits for adolescents

The hypotheses are that text-messaged reminders to parents of adolescents will result in improved rates of HPV vaccine series initiation, HPV vaccine series completion, will decrease the intervals between vaccine doses and will improve rates of preventive care among adolescents. Parents receiving specific text-messaged reminders about services (i.e. HPV vaccination, well child care visits) for which their adolescent is due will be compared to a control group of parents receiving general health tips through text messages.

Completed

Looking for future studies?

Notify Me

Key information

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

The study setting is western New York State and the Southern Tier of New York State (15 counties total). Investigators will work with the Monroe Plan for Medical Care, an IPA-model managed care organization (MCO) that serves Medicaid managed care and SCHIP enrollees. The MCO will conduct regular reviews of insurance claims data and the New York State Immunization Information System of adolescents ages 11-<16 years. Parents (all over 18 years of age) of adolescents will receive the texted messages on their phones.

There are no enrollment restrictions based upon race or ethnic origin. The inclusion criteria are that the adolescents are a) enrolled in Medicaid or SCHIP through the Monroe Plan, b) have been enrolled greater than 6 months with the Monroe Plan (in order to have sufficient claims data to determine whether they are due for a well child care visit or recommended immunizations), c) the Monroe Plan has received their consent to send preventive care text messages, d) their child attend a primary care practice that has agreed to participate and d) they are between the ages of 11-<16 years at the start of the study.

The key independent measure is group allocation (intervention vs. control); an intention-to-treat strategy will be used to assess the effectiveness of text messaging reminders. Key outcome measures will be: 1) receipt of 0, 1, 2 or 3 doses of HPV vaccine 2) interval (in days) between doses and 3) having a preventive visit in the 6 month period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 11-<18 years
  • Member of MCO for >6 months
  • Opted in to receive texted reminders from MCO

Exclusion criteria

Treatment and study plan

Text-based reminder for recommended HPV vaccine or WCC

Other

Patients due for a well visit or HPV vaccine received a text reminder

Non-specific text-based reminder (general health tip)

Other

Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Primary outcomes

  1. Percentage of Participants Receiving HPV Vaccination (Dose 1)

    Time frame: 9 months

    Participants who received HPV vaccine dose 1 Kaplan-Meier failure function

Secondary outcomes

  1. Percentage of Participants Receiving HPV Vaccination (Dose 2)

    Time frame: 9 months

    Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function

  2. Percentage of Participants Receiving HPV Vaccination (Dose 3)

    Time frame: 9 months

    Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Acronym: TRIO

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 7, 2013
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.