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COVID-19 quarantines disrupted study and funding ended.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after end of treatment, representative of 24-36 weeks after anti-HCV screening |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 to 36 weeks after anti-HCV screening |
Inclusion Criteria:
- Report being homeless and meet the Albuquerque Healthcare for the homeless HCH operating definition of homeless
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albuquerque HealthCare for the Homeless | Albuquerque | New Mexico | 87102 | United States | ||
| University of New Mexico Health Sciences Center |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Randomized controlled trial.
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Study staff who abstract outcomes from medical record will not be aware of patients' study arm allocation.
|
| Albuquerque |
| New Mexico |
| 87131 |
| United States |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |