Way to Cure HCV Adherence
WTC
Way to Cure: Developing Effective Strategies to Promote Adherence to Hepatitis C Therapy Among Older Adults
1 other identifier
interventional
60
1 country
2
Brief Summary
This is a 3-arm, multi-center, patient-randomized, field evaluation of the "Way to Cure" behavioral interventions on medication adherence in HCV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 8, 2022
February 1, 2022
2.5 years
March 19, 2015
February 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Pill bottle measured adherence
12 weeks of treatment
Study Arms (3)
Arm 1: Control
OTHERMedSignals pill box will be set into "quiet mode" to track patient compliance. This mode sends daily adherence data to the Way to Health platform each time the participant opens the pill box, however, does not remind the participant to take the medication.
Arm 2: Reminders/Feedback
EXPERIMENTALMedSignals pill box will track patient compliance and the Way to Health platform will allow participants to receive tailored text message reminders to take the medication if in case the interval from last cap opening is \>30 hours (greater than 6 hours overdue).
Arm 3: Reminders/Feedback/Incentives
EXPERIMENTALMedSignals pill box will track patient compliance and in addition to reminders with missed doses and weekly adherence feedback, patients in this arm will be eligible to receive a small financial incentive each week they demonstrate perfect \>85% adherence. The weekly adherence feedback message will also alert patients whether they earned the incentive for the past week.
Interventions
Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
Eligibility Criteria
You may qualify if:
- a) age 50 older, b) prescribed a fixed dose combination HCV regimen containing sofosbuvir/ledipasvir for 12 weeks, and 3) willing to receive text message communications.
You may not qualify if:
- a) non-English speaking, b) have severe vision, hearing impairment precluding study participation, c) no text messaging capability, d) decompensated cirrhosis requiring hospitalization in the past 30 days, e) medication primarily given by a caregiver/facility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Corporal Michael J. Crescenz VA Medical Centercollaborator
- Northwestern Universitycollaborator
Study Sites (2)
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Reese, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2015
First Posted
June 16, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2021
Last Updated
February 8, 2022
Record last verified: 2022-02