NCT06634342

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). We aim to answer the following questions: 1\. How will point-of-care HCV RNA testing with Xpert, provided at an SSP, effect how people who use drugs receive their results, get linked to HCV care services, and initiate and complete HCV treatment\> Aim 2: What are the most effective ways to implement point of care HCV RNA testing in syringe services programs?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

October 7, 2024

Last Update Submit

October 7, 2024

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 are connected with HCV treatment who are cured of HCV.

    6 months

Secondary Outcomes (2)

  • Testing willingness

    6 months

  • Testing results

    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 testingDIAGNOSTIC_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

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sara Glick, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Glick, PhD, MPH

CONTACT

206-263-2044snglick@uw.edu

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

November 1, 2024

Primary Completion

April 1, 2025

Study Completion

July 1, 2025

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share