NCT01276184

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2016

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

July 14, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

5.5 years

First QC Date

January 11, 2011

Results QC Date

February 21, 2018

Last Update Submit

July 13, 2021

Conditions

HPV Vaccines

Keywords

HPV VaccineHPV vaccinationSMSText MessageGardasil

Outcome Measures

Primary Outcomes (1)

  • Number of Participants That Adhered to Vaccine Schedule

    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.

    at the end of the study (30 days after the third vaccination or 360 days after the first vaccination, whichever comes first)

Study Arms (2)

Usual Care

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

SMS Text MessageBEHAVIORAL

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).

Also known as: Usual care, Text message
SMS Text Message

Eligibility Criteria

Age12 Years - 26 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant
  • Previously completed the Gardasil vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Redwood Clinic

Baltimore, Maryland, 21201, United States

Location

Western-Penn Center

Baltimore, Maryland, 21201, United States

Location

Results Point of Contact

Title
Dr. J. Kathleen Tracy, PhD
Organization
University of Maryland School of Medicine
ktracy@som.umaryland.edu
410-706-1205

Study Officials

  • Kathleen Tracy, Ph.D.

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 13, 2011

Study Start

January 1, 2011

Primary Completion

June 15, 2016

Study Completion

June 15, 2016

Last Updated

July 14, 2021

Results First Posted

July 14, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)