Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT01276184 |
Other study ID # |
HP-00047046 |
Secondary ID |
GCC 1063GCCMerck |
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 2011 |
Est. completion date |
June 15, 2016 |
Study information
Verified date |
July 2021 |
Source |
University of Maryland, Baltimore |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Human papillomavirus (HPV) is the most common sexually transmitted disease among adolescent
females in the United States. Our primary objective is to determine if Short Message Service
(SMS) text message reminders increase adherence to the recommended 3 dose schedule for
Gardasil compared to usual care in an outpatient clinic setting. Secondary objectives of this
study are: 1) to demonstrate the feasibility of using SMS text message reminders to increase
adherence with Gardasil vaccination; and 2) to assess satisfaction and acceptability of text
message reminders compared to telephone reminders among women who receive the text message
arm of the intervention. The investigators hypothesize that receiving SMS text message
reminders will increase adherence to the recommended 3 dose schedule for Gardasil compared to
usual care.
Description:
Technological innovations such as Short Message Service (SMS) text messages reminders are one
strategy that may be used to increase adherence to the Gardasil dosing schedule. Although the
literature in this area is in its infancy, several studies have demonstrated that SMS text
reminders are an effective strategy for reducing nonattendance with medical appointments.
Further, SMS text message reminders have been shown to be popular with patients and more
cost-effective than paper or telephone-based reminder strategies. The investigators believe
SMS text message reminders can be used as a feasible and cost-effective strategy to increase
adherence to the Gardasil vaccine schedule, thus reducing risk of cervical cancer.
Women who are enrolled will be randomly assigned to one of 2 study groups (Usual Care v. SMS
Text Message group). For women in the SMS Text Message group, text message reminders will be
sent once per day for each of the seven days prior to the scheduled date for each of their
follow up vaccinations. Participants follow the usual practices for scheduling their follow
up visit(s) for vaccination at the clinic. Participants in both the Usual Care group and the
SMS Text Message group will receive the standard reminder from the clinic for their scheduled
appointment(s) (phone call, letter, etc, as appropriate). At enrollment, the participant will
answer questions regarding social and demographic history, cell phone use patterns, attitudes
and acceptance of HPV vaccine, gynecologic and sexual history.
All participants will be sent a packet of self-report measures to complete regarding
attitudes toward HPV vaccination at the completion of the study. Participants in the SMS Text
Message group will also receive rating scales to assess acceptability of text message
reminders and preference for text message reminders over telephone reminders.