Trial Outcomes & Findings for Effectiveness of SMS (Short Message Service) Text Messaging in Increasing Adherence to Gardasil (NCT NCT01276184)
NCT ID: NCT01276184
Last Updated: 2021-07-14
Results Overview
Our primary objective is to determine if Short Message Service (SMS) text message reminders increase number of participants that adhered to the recommended 3 dose schedule for Gardasil compared to usual care in an outpatient clinic setting.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
at the end of the study (30 days after the third vaccination or 360 days after the first vaccination, whichever comes first)
Results posted on
2021-07-14
Participant Flow
22 participants recruited.
Participant milestones
| Measure |
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).
|
SMS Text Message
Participants in both 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.
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,
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
9
|
|
Overall Study
COMPLETED
|
13
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of SMS (Short Message Service) Text Messaging in Increasing Adherence to Gardasil
Baseline characteristics by cohort
| Measure |
Usual Care
n=13 Participants
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).
|
SMS Text Message
n=9 Participants
Participants in both Usual Care group and the Text Message group will receive the standard reminder from the clinic for their scheduled appointment(s). 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.
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).
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
19 years
n=93 Participants
|
17 years
n=4 Participants
|
18 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
9 participants
n=4 Participants
|
22 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at the end of the study (30 days after the third vaccination or 360 days after the first vaccination, whichever comes first)Our primary objective is to determine if Short Message Service (SMS) text message reminders increase number of participants that adhered to the recommended 3 dose schedule for Gardasil compared to usual care in an outpatient clinic setting.
Outcome measures
| Measure |
Usual Care
n=13 Participants
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).
|
SMS Text Message
n=9 Participants
Participants in both 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.
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,
|
|---|---|---|
|
Number of Participants That Adhered to Vaccine Schedule
|
10 Participants
|
8 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SMS Text Message
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. J. Kathleen Tracy, PhD
University of Maryland School of Medicine
Phone: 410-706-1205
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place