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One-step HCV RNA Testing Among SSP Participants (HOT Study)

NCT06634342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-06-24

Study results available
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Summary

The HOT (HCV One-step Test) Study is an observational prospective study to evaluate the use of a recently FDA-approved point-of-care RNA test for hepatitis C virus (HCV) in a sample of clients of a syringe services program (SSP). The investigators aim to answer the following questions:

1\. How will point-of-care HCV RNA testing with the Xpert HCV test, provided at an SSP, affect how people who use drugs receive their results, get linked to HCV care services, and initiate and complete HCV treatment?

2: What are the most effective ways to implement point of care HCV RNA testing in syringe services programs?

Conditions

  • Testing Effect of Intervention

Interventions

DIAGNOSTIC_TEST

HCV RNA Rapid testing

Participants will receive point-of-care hepatitis C RNA testing using the GeneXpert IV Xpress System technology.

Sponsors & Collaborators

Principal Investigators

  • Sara Glick, PhD, MPH · University of Washington

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2025-05-31
Completion
2026-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06634342 on ClinicalTrials.gov