Rapid HCV RNA Testing and LInkage to Care

NCT04302948 | Terminated

• 1 other identifier: 19-232
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators propose to conduct a pilot randomized controlled trial comparing treatment as usual (TaU) for HCV screening (rapid anti-HCV screening and referral) to a intervention screening that includes TaU plus a rapid point-of-care HCV RNA test in persons experiencing homelessness. The primary outcome of interest is linkage-to-care. Linkage to care is defined as evaluation by a health care provider for HCV infection within 30 days of baseline screening and referral. We will compare the proportion of patients who are evaluated by a provider within the 30 day window in each study arm: (1) participants who screened positive with rapid anti-HCV and are referred for evaluation) and (2) Rapid HCV RNA plus TaU (those who tested positive with both rapid anti-HCV and confirmatory RNA and are also referred to a provider.) Secondarily, the investigators will also assess HCV RNA levels in both groups twelve weeks after treatment ends (24 to 36 weeks after anti-HCV screening) to determine the percent of individuals who achieved sustained virologic response (SVR12), which is a marker for cure.

Conditions

Hepatitis C, Chronic

Keywords

Diagnostics; Point-of-care system

Outcome Measures

Primary Outcomes (1)

• Percentage of participants in each study arm who are evaluated by a provider specifically for HCV infection after screening

  Evaluation HCV infection by a health care provider will be assessed as having attended a clinic visit based on medical record review

  Within 30 days of anti-HCV screening

Secondary Outcomes (1)

• The proportion of patients in each study arm who achieve sustained viral response (SVR-12)

  12 weeks after end of treatment, representative of 24-36 weeks after anti-HCV screening

Other Outcomes (1)

• Proportion of patients in each study arm who have receive any HCV-treatment related support services

  24 to 36 weeks after anti-HCV screening

Study Arms (2)

Treatment as usual

NO INTERVENTION

TaU includes screening for anti-HCV using a rapid point-of-care (PoC) test to screen for exposure to HCV followed by counseling, brief education and referral to provider for further evaluation for HCV treatment.

Rapid PoC RNA testing

EXPERIMENTAL

Intervention arm includes Tau ( screening for anti-HCV using a rapid point-of-care (PoC) test, and a rapid PoC screening test for HCV RNA, counseling plus, brief education and referral to a provider for further evaluation for HCV treatment. Rapid HCV RNA testing will be conducted using Cepheid Xpert (r) system.

Other: HCV RNA screening

Interventions

HCV RNA screening OTHER

The Cepheid Xpert testing requires a fingerstick to obtain blood spots which are then tested for HCV RNA. Results available within one to two hours, facilitating counseling for patients to link to care.

Also known as: Cepheid Xpert system

Rapid PoC RNA testing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Report being homeless and meet the Albuquerque Healthcare for the homeless HCH operating definition of homeless

You may not qualify if:

• having stable housing

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (2)

Albuquerque HealthCare for the Homeless

Albuquerque, New Mexico, 87102, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study staff who abstract outcomes from medical record will not be aware of patients' study arm allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 10, 2020
• Study Start: March 2, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)