NCT06508996

Brief Summary

A multi-site prospective, all comers study that was conducted at geographically diverse locations in the United States.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,012

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 8, 2024

Last Update Submit

July 12, 2024

Conditions

HCV

Outcome Measures

Primary Outcomes (1)

  • Percent Agreement compared to Patient infected status (PIS)

    Clinical performance comparing Xpert test to PIS (NAAT + Antibody status)

    1 day

Study Arms (1)

Capillary whole blood

Capillary whole blood from individuals with signs and symptoms and/or at-risk of HCV infection

Diagnostic Test: Xpert HCV

Interventions

Xpert HCVDIAGNOSTIC_TEST

Detection of HCV RNA by Xpert HCV test

Capillary whole blood

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Specimens collected from individuals showing signs and symptoms and/or at risk of HCV infection

You may qualify if:

  • Participant was ≥18 years old
  • Participant was not on treatment at time of enrollment based on review of medical records or self-reported
  • Participant had signs and symptoms and/or is considered at-risk of HCV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

capillary and venous whole blood collected from consented individuals with signs and symptoms and/or individuals at-risk of HCV infection, irrespective of HCV antibody status.

Study Officials

  • Jennifer Havens

    University of Kentucky College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 19, 2024

Study Start

February 6, 2024

Primary Completion

May 10, 2024

Study Completion

June 6, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)