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Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care Continuum

StatusRecruiting
PhaseNot applicable
Started2022-03-24
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later across 2 updates Jul 2026 → Apr 2027
See other at-risk trials from Johns Hopkins University

Amendment history

2026-09-30
critical
Primary completion pushed: 2026-09 → 2027-04
Completion pushed: 2026-12 → 2027-07
2026-07-24
notable
Study Status v19
Primary completion pushed: 2026-07 → 2026-09
Completion pushed: 2026-09 → 2026-12
2025-12-10
minor
Study Status v18
Primary completion date2025-12→2026-07
Completion date2026-04→2026-09
2025-03-06
minor
Study Status v17
Re-verified, no change to tracked fields
2024-03-14
minor
Study Status v16
Primary completion date2024-12→2025-12
Completion date2025-04→2026-04
Show 15 earlier versions
2023-03-28
minor
Study Status v15
Primary completion date2024-10→2024-12
Completion date2025-02→2025-04
2022-03-29
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v14
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-03→confirmed 2022-03-24
Study sitesdetails revised at 1 of 1 site
2022-02-28
minor
Study Status v13
Primary completion date2024-09→2024-10
Completion date2025-01→2025-02
Start date2022-02→2022-03
2022-02-01
minor
Study Status v12
Primary completion date2024-08→2024-09
Completion date2024-12→2025-01
Start date2022-01→2022-02
2022-01-04
minor
Study Status v11
Primary completion date2024-07→2024-08
Completion date2024-11→2024-12
Start date2021-12→2022-01
2021-12-01
minor
Study Status v10
Primary completion date2024-06→2024-07
Completion date2024-10→2024-11
Start date2021-11→2021-12
2021-10-29
minor
Study Status v9
Primary completion date2024-05→2024-06
Completion date2024-09→2024-10
Start date2021-10→2021-11
2021-10-06
minor
Study Status v8
Re-verified, no change to tracked fields
2021-07-13
minor
Study Status v7
Primary completion date2024-01→2024-05
Completion date2024-05→2024-09
Start date2021-06→2021-10
2021-04-01
minor
Study Status v6
Primary completion date2023-10→2024-01
Completion date2024-02→2024-05
Start date2021-03→2021-06
2021-02-01
minor
Study Status v5
Primary completion date2023-08→2023-10
Completion date2023-12→2024-02
Start date2021-01→2021-03
2020-10-28
minor
Study Status v4
Primary completion date2023-05→2023-08
Completion date2023-09→2023-12
Start date2020-10→2021-01
2020-07-28
minor
Study Status v3
Primary completion date2023-02→2023-05
Completion date2023-06→2023-09
Start date2020-07→2020-10
2020-04-16
minor
Study Status v2
Primary completion date2022-08→2023-02
Completion date2022-08→2023-06
Start date2020-04→2020-07
2020-01-28
minor
Study Status v1
Primary completion date2022-05→2022-08
Completion date2022-05→2022-08
Start date2020-01→2020-04
2019-11-12
minor
Original filing
The investigators will conduct a randomized controlled clinical trial study in an urban emergency department in Baltimore to determine the impact of an educational app which is based on Leventhal's Common-Sense Model of Illness Representations framework, on HCV-infected ED patient's hepatitis C virus (HCV) health belief and knowledge as well as the downstream outcomes of the HCV Continuum of Care (linkage to care rate, initiation of HCV antiviral treatment, and sustained virologic response). First, the investigators will develop a blueprinted prototype personalized HCV educational app which will (1) provide individualized liver fibrosis staging information, (2) pre-test HCV knowledge, perception of barriers to HCV care, and motivation to receive HCV care survey, (3) provide personalized HCV knowledge, facilitators and supporting information for HCV care via video clips and information sheets based on the pre-test results, and (4) provide post-test knowledge, perception, and motivation to receive HCV care. Second, the investigators will conduct a series of focus group discussion sessions to fine-tune the HCV educational app. Third, the investigators will enroll ED patients who have anti-HCV (newly diagnosed or previously diagnosed) but without HCV RNA testing information for a pilot randomized controlled clinical trial of the personalized HCV educational app.
Trial Details
NCT Number NCT04162938
Lead Sponsor Johns Hopkins University
Conditions Hepatitis C
Enrollment 308 participants
Start Date 2022-03-24
Primary Completion 2027-04 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-29