Clinical trial NCT01276184: Effectiveness of SMS (Short Message Service) Text Messaging in Increasing Adherence to Gardasil
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).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HPV Vaccines
Keywords: HPV Vaccine
HPV vaccination
SMS
Text Message
Gardasil
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-01-13
Enrollment: 22
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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 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

Primary outcomes:
measure: Number of Participants That Adhered to Vaccine Schedule
timeFrame: at the end of the study (30 days after the third vaccination or 360 days after the first vaccination, whichever comes first)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Redwood Clinic
state: Maryland
city: Baltimore
country: United States
facility: Western-Penn Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Kathleen Tracy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: