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

NCT06634342 | Completed Results FDA Device

• 1 other identifier: STUDY00021203
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Receipt of HCV RNA Test Results

  Percentage of individuals who complete a HCV RNA test and who also receive their test results.

  6 months

• Linkage to HCV Care

  Percentage of individuals who test positive for HCV who are connected with HCV treatment services

  6 months

• Cure Rate

  Percentage of individuals who test positive for HCV who are cured of HCV.

  6 months

Secondary Outcomes (2)

• Testing Results

  6 months

• Testing Willingness

  6 months

Study Arms (1)

Participants of a syringe services program

EXPERIMENTAL

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 testing DIAGNOSTIC_TEST

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

Participants of a syringe services program

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum age of 22

You may not qualify if:

• Already knows they are infected with hepatitis C virus.
• Past participation in this study.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Public Health-Seattle & King County

Seattle, Washington, 98104, United States

Location

Results Point of Contact

• Title: Dr. Sara Glick
• Organization: University of Washington

snglick@uw.edu

206-263-2044

Study Officials

• Sara Glick, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: Medicine- Allergy and Infectious Disease

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: February 5, 2025
• Primary Completion: May 31, 2025
• Study Completion: April 30, 2026
• Last Updated: June 24, 2026
• Results First Posted: June 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)