Way to Cure HCV Adherence

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02472925

Acronym

WTC

Enrollment

Registered

2015-06-16

Start date

2015-06-30

Completion date

2021-12-31

Last updated

2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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.

Detailed description

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.

Interventions

BEHAVIORALMedSignals Pill Box

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pill bottle measured adherence	12 weeks of treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026