Effectiveness of SMS (Short Message Service) Text Messaging in Increasing Adherence to Gardasil

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Maryland.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01276184
First received: January 11, 2011
Last updated: January 12, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
HPV Vaccines
Behavioral: SMS Text Message

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Randomized, Controlled Trial to Compare the Effectiveness of SMS Text Message Reminders Compared to Usual Care to Increase Adherence to the Gardasil Vaccine Dosing Schedule (GCC 1063GCC).

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Percent of adherence to vaccine schedule [ Time Frame: at the end of the study (30 days after the third vaccination or 360 days after the first vaccination, whichever comes first) ] [ Designated as safety issue: No ]
    Our primary objective is to determine if Short Message Service (SMS) text message reminders increase percent of adherence to the recommended 3 dose schedule for Gardasil compared to usual care in an outpatient clinic setting.


Secondary Outcome Measures:
  • Feasibility of using SMS text message reminders [ Time Frame: at the end of the study (30 days after the third vaccination or 360 days after the first vaccination, whichever comes first) ] [ Designated as safety issue: No ]
    Demonstrate the feasibility of using SMS text message reminders to increase adherence with Gardasil vaccination.

  • Satisfaction and acceptability of text message reminders [ Time Frame: at the end of the study (30 days after the third vaccination or 360 days after the first vaccination, whichever comes first) ] [ Designated as safety issue: No ]
    Assess satisfaction and acceptability of text message reminders compared to telephone reminders among women who receive the text message arm of the intervention.


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Participants follow the usual practices for scheduling their follow up visit(s) for vaccination at the clinic. Participants will receive the standard reminder from the clinic for their scheduled appointment(s) (phone call, letter, etc, as appropriate).
Behavioral: SMS Text Message
Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit (or as many days as possible depending on when the rescheduled visit will take place - for example, if they call in and reschedule the visit to take place in 4 days, they will receive text messages for the 3 days prior to the rescheduled visit). Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their re-scheduled appointment(s) (phone call, letter, etc, as appropriate).
Other Names:
  • Usual care
  • Text message
Experimental: SMS Text Message
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). Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit.
Behavioral: SMS Text Message
Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit (or as many days as possible depending on when the rescheduled visit will take place - for example, if they call in and reschedule the visit to take place in 4 days, they will receive text messages for the 3 days prior to the rescheduled visit). Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their re-scheduled appointment(s) (phone call, letter, etc, as appropriate).
Other Names:
  • Usual care
  • Text message

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a mobile phone with text message capability
  • Patient of University of Maryland Medical Center outpatient gynecology clinics
  • Able to speak and read English
  • Capable of understanding, consenting, and complying with the entire study protocol

Exclusion Criteria:

  • Pregnant
  • Previously completed the Gardasil vaccine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276184

Contacts
Contact: Julie Medalie 410-706-2060 jmedalie@epi.umaryland.edu

Locations
United States, Maryland
Redwood Clinic Not yet recruiting
Baltimore, Maryland, United States, 21201
Western-Penn Center Not yet recruiting
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Kathleen Tracy, Ph.D. University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: Kathleen Tracy, University of Maryland
ClinicalTrials.gov Identifier: NCT01276184     History of Changes
Other Study ID Numbers: HP-00047046, GCC 1063GCC, Merck-37944
Study First Received: January 11, 2011
Last Updated: January 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
HPV Vaccine
HPV vaccination
SMS
Text Message
Gardasil

ClinicalTrials.gov processed this record on July 24, 2014