Hepatitis C, ChronicTEALNCT04302948
Rapid HCV RNA Testing and LInkage to Care
A study testing HCV RNA screening in people with Hepatitis C, Chronic, run by University of New Mexico at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- HCV RNA screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Mar 2020to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Report being homeless and meet the Albuquerque Healthcare for the homeless HCH operating definition of homeless
Who cannot join
- having stable housing
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Albuquerque HealthCare for the Homeless
Albuquerque, New Mexico, 87102
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
About this study
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.
Read the 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.
- Conditions
- Hepatitis C, Chronic
- Being tested
- HCV RNA screening
- Keywords
- Diagnostics, Point-of-care system
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV RNA screeningOther
Also called Cepheid Xpert system
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HCV RNA screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
SVR-12 weeks after end of treatment based on medical record review.
Measured: 12 weeks after end of treatment, representative of 24-36 weeks after anti-HCV screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start2 Mar 2020
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: COVID-19 quarantines disrupted study and funding ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Page, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302948
- Sponsor's protocol ID
- 19-232
- Acronym
- TEAL
- Status last verified
- Jan 2024
- First submitted
- 4 Mar 2020
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid HCV RNA Testing and LInkage to Care
- ClinicalTrials.gov ID
- NCT04302948
- Acronym / sponsor ID
- TEAL / 19-232
- Conditions
- Hepatitis C, Chronic
- Keywords
- Diagnostics, Point-of-care system
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 quarantines disrupted study and funding ended.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: HCV RNA screeningIntervention 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Report being homeless and meet the Albuquerque Healthcare for the homeless HCH operating definition of homeless
Key exclusion criteria (1 listed)
- having stable housing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCV RNA screeningAlso: Cepheid Xpert systemThe 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. | Other | Rapid PoC RNA testing |
Primary outcome
Percentage of participants in each study arm who are evaluated by a provider specifically for HCV infection after screening
Time frame: Within 30 days of anti-HCV screening
Evaluation HCV infection by a health care provider will be assessed as having attended a clinic visit based on medical record review
1 secondary outcome
The proportion of patients in each study arm who achieve sustained viral response (SVR-12)
Time frame: 12 weeks after end of treatment, representative of 24-36 weeks after anti-HCV screening
Results and safety
The study was stopped early (reason given: COVID-19 quarantines disrupted study and funding ended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C, Chronic
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCV RNA screening in people with Hepatitis C, Chronic, run by University of New Mexico at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 quarantines disrupted study and funding ended.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants in each study arm who are evaluated by a provider specifically for HCV infection after screening (time frame: Within 30 days of anti-HCV screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.