CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled / 200 target
Drug / intervention
HCV RNA Rapid testingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06634342
NCT06634342N/ACompletedHigh Momentum (11.9/mo)Completion was 13mo ago

Clinical Utility and Feasibility of a One-step HCV Testing Algorithm for Clients of a U.S. Syringe Services Program

University of Washington·interventional·Posted Oct 9, 2024·Updated Jun 24, 2026

In Brief

A clinical study evaluating HCV RNA Rapid testing for Testing Effect of Intervention. Completed, enrolled 200 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedOct 9, 2024
Enrollment StartFeb 5, 2025
Primary CompletionMay 31, 2025
Study CompletionApr 30, 2026
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 1.7 years ago

Arms & Interventions

Participants of a syringe services programexperimental

Participants of the syringe services program who will be offered point-of-care hepatitis C RNA testing will be adults 22 or older who do not already know they have HCV infection.

Diagnostic Test: HCV RNA Rapid testing

Interventions

HCV RNA Rapid testingother

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