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Completed

NCT Number: NCT02472925

Way to Cure HCV Adherence

This is a 3-arm, multi-center, patient-randomized, field evaluation of the "Way to Cure" behavioral interventions on medication adherence in HCV.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania, United States

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About this study

This 3-arm trial will field test the efficacy of "Way to Cure" intervention on medication adherence in Hepatitis C for 12 weeks. As part of routine clinical care all patients will receive medication counseling regarding proper use and side effects by trained nurses or pharmacists depending on the clinical site.

Arm 1: Control (n=20) - Monitoring pill box will be set into "quiet mode". This mode sends daily adherence data to the Way to Health platform each time the participant opens the pill bottle, however, does not remind the participant to take the medication. In the event no electronic signal is received by the platform for 96 hours, the RA will call the participant to assess any usability or connectivity issues.

Arm 2: Intervention - Reminders/Feedback (n=20) - Patients will receive tailored text message reminders to take the medication if in case the interval from last box opening is >30 hours (greater than 6 hours overdue). Patients will receive weekly text messages with summary cumulative adherence scores.

Arm 3: Intervention - Reminders/Feedback and Financial Incentives (n=20) - In addition to reminders with missed doses and weekly adherence feedback, patients in this arm will be eligible to receive a 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

MedSignals Pill Box

Behavioral

Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.

Primary outcomes

  1. Pill bottle measured adherence

    Time frame: 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Corporal Michael J. Crescenz VA Medical Center
  • Northwestern University

Registry information

Official study title

Way to Cure: Developing Effective Strategies to Promote Adherence to Hepatitis C Therapy Among Older Adults

Acronym: WTC

Important dates

Study start
2015
Primary completion
2017
Study completion
2021
First posted
Jun 16, 2015
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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