An interventional study of HCV RNA screening in Hepatitis C, Chronic, sponsored by University of New Mexico. Terminated at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment
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.
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).
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 31 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: HCV RNA screening
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
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
Time frame: Within 30 days of anti-HCV screening
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.
Time frame: 12 weeks after end of treatment, representative of 24-36 weeks after anti-HCV screening
Proportion of patients in each study arm who have receive any HCV-treatment related support services
Case-management, patient navigation, participation in support groups or other supportive services.
Time frame: 24 to 36 weeks after anti-HCV screening
Plan to share: No
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This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of New Mexico