Viewing Study NCT01276184



Ignite Creation Date: 2024-05-05 @ 11:10 PM
Last Modification Date: 2024-10-26 @ 10:30 AM
Study NCT ID: NCT01276184
Status: TERMINATED
Last Update Posted: 2021-07-14
First Post: 2011-01-11

Brief Title: Effectiveness of SMS Short Message Service Text Messaging in Increasing Adherence to Gardasil
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

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
Status: TERMINATED
Status Verified Date: 2021-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Unable to recruit sufficient sample for study completion
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CHAT
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 visits 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 appointments 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
Merck-37944 OTHER_GRANT Merck None
GCC 1063GCC OTHER None None