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Rapid HCV RNA Testing and LInkage to Care (TEAL)

Primary Purpose

Hepatitis C, Chronic

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HCV RNA screening
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Diagnostics, Point-of-care system

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • having stable housing

Sites / Locations

  • Albuquerque HealthCare for the Homeless
  • University of New Mexico Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as usual

Rapid PoC RNA testing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The proportion of patients in each study arm who achieve sustained viral response (SVR-12)
SVR-12 weeks after end of treatment based on medical record review.

Full Information

First Posted
March 4, 2020
Last Updated
October 26, 2022
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04302948
Brief Title
Rapid HCV RNA Testing and LInkage to Care
Acronym
TEAL
Official Title
Rapid HCV RNA Testing and LInkage to Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 quarantines disrupted study and funding ended.
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The goal of this study is to simplify the HCV testing process using combined rapid screening and confirmation in order to reduce early barriers and improve linkage to care among a vulnerable high-risk homeless population. The investigators are partnering with Albuquerque Health Care for the Homeless (AHCH) to conduct rapid testing and provide counseling, test results, and referrals directly on site. After Rapid HCV testing the investigators will randomize participants to 1) counseling and referral to a provider, or 2) Rapid RNA testing plus counseling and referrals to a provider. The study's primary is to to assess linkage to care, which is the percent of subjects who are evaluated by a provider specifically for HCV infection in both groups. Linkage to care will be determined via medical chart abstraction 30 days after testing. The investigators hypothesize that there will be a 30% absolute difference in linkage to care between study arms, with a higher percent of participants in the combined rapid testing group being linked to a provider for evaluation relative to the control group (rapid anti-HCV alone). The study's second aim is exploratory in nature and sequentially follows the first aim. The investigators will also assess HCV Cascade of care in both group, and by medical chart abstraction (up to 36 weeks after study entry) to determine the number and proportion of individuals who achieved sustained virologic response (SVR12), which is a marker for cure. The study's third aim is a qualitative inquiry into the use of supportive services by participants during treatment. Such services may include social work, case management, patient navigation, participation in support groups, etc. The investigators will review medical charts for this information. The investigators are interested to see if more individuals in one study arm will access one or more of these supportive services compared to the other study arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Diagnostics, Point-of-care system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial.
Masking
Outcomes Assessor
Masking Description
Study staff who abstract outcomes from medical record will not be aware of patients' study arm allocation.
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
Rapid PoC RNA testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HCV RNA screening
Other Intervention Name(s)
Cepheid Xpert system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of participants in each study arm who are evaluated by a provider specifically for HCV infection after screening
Description
Evaluation HCV infection by a health care provider will be assessed as having attended a clinic visit based on medical record review
Time Frame
Within 30 days of anti-HCV screening
Secondary Outcome Measure Information:
Title
The proportion of patients in each study arm who achieve sustained viral response (SVR-12)
Description
SVR-12 weeks after end of treatment based on medical record review.
Time Frame
12 weeks after end of treatment, representative of 24-36 weeks after anti-HCV screening
Other Pre-specified Outcome Measures:
Title
Proportion of patients in each study arm who have receive any HCV-treatment related support services
Description
Case-management, patient navigation, participation in support groups or other supportive services.
Time Frame
24 to 36 weeks after anti-HCV screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Report being homeless and meet the Albuquerque Healthcare for the homeless HCH operating definition of homeless Exclusion Criteria: having stable housing
Facility Information:
Facility Name
Albuquerque HealthCare for the Homeless
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Rapid HCV RNA Testing and LInkage to Care

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