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Electronic Message

Phase 1

Patient Compliance | Unknown | Other |Merck & Company, Inc.|Last Updated: Nov 4, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment283
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01568515Electronic Messaging to Increase Human Papillomavirus Vaccine Utilization and Adherence Among College StudentsEARLY_PHASE1 COMPLETED 283Oct 1, 2011Aug 1, 2014Nov 4, 2014 -
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Study Endpoints
Primary Endpoints
Increase in HPV vaccine uptake among intervention group participants.
One year

To determine if electronic reminders coupled with electronic educational messaging can increase HPV vaccine use and adherence among college students in eastern North Carolina.

Secondary Endpoints
Increase knowledge of HPV and HPV vaccine among intervention group participants
One year
Compliance rates among Race/ethnicity and other socio-demographic characteristics.
One year
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Electronic MessagesEXPERIMENTALIntervention group participants received electronic (text and/or email) reminder messages coupled with health educational messages about HPV and HPV vaccine across 7 months
Standard of CareNO_INTERVENTIONControl group participants received standard of care at the student health center which included a card with their next appointment written on it.
Interventions
NameTypeDescription
Electronic MessagePROCEDUREStudents enrolled in the intervention group received 7 electronic contacts over a 7-month period. Specifically, participants received 4 electronic education messages, 2 electronic reminder/education messages, as well as 1 baseline and 1 final assessment contacts. Up to 4 reminder contacts were used if surveys were not completed for both intervention and control group participants. Control group participants will receive 2 contacts throughout the study, 1 at baseline and 1 at their final assessment. Up to 4 reminder contacts were used if surveys were not completed. Intervention \& control groups were compared longitudinally for 7 months on the differences in HPV vaccine utilization and adherence, knowledge and attitudes about HPV, and the HPV vaccine (parallel design).
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Eligibility Criteria
Age Range18 Years — 26 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Male \& Female Students enrolled at East Carolina University (ECU) Exclusion Criteria: * Non-English speaking students * Students under the age of 18 or over 26 * Individuals not enrolled at ECU

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