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

January 11, 2011
January 12, 2011
January 2011
July 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01276184 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Effectiveness of SMS (Short Message Service) Text Messaging in Increasing Adherence to Gardasil
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).

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
HPV Vaccines
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
  • 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).
    Intervention: Behavioral: SMS 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.
    Intervention: Behavioral: SMS Text Message
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
January 2013
July 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 26 Years
Yes
Contact: Julie Medalie 410-706-2060 jmedalie@epi.umaryland.edu
United States
 
NCT01276184
HP-00047046, GCC 1063GCC, Merck-37944
No
Kathleen Tracy, University of Maryland
University of Maryland
Merck Sharp & Dohme Corp.
Principal Investigator: Kathleen Tracy, Ph.D. University of Maryland, Baltimore County
University of Maryland
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP