Hepatitis C, Chronic Clinical Trial
— NOWOfficial title:
The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study
Verified date | January 2023 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) offers a cure to those with chronic HCV infection. For marginalized communities, linkage to care services often aren't enough to overcome barriers to accessing the medical system. For difficult to link populations, offering treatment at the same non-clinical community space may improve uptake and reduce loss-to-follow-up. The purpose of this 2 year study is to assess the feasibility, acceptability and effectiveness of accelerated initiation of commercially available DAA therapy targeting socially marginalized communities (e.g., medically underserved, homeless, people actively injecting drugs). The study will be carried out at two community sites that perform HCV testing: (a) fixed community site and (b) community mobile site via clinical research van. Participants (n=150) who test anti-HCV positive and HCV RNA positive (chronic infection) are invited to enroll into the no one waits (NOW) Study and begin HCV treatment at point of diagnosis. All evaluation, medication dissemination, and follow-up care will take place at the project site. The investigators will estimate the effect of on-site point-of-diagnosis (POD) treatment on (1) time from HCV testing to treatment initiation, (2) completing treatment, and (3) attaining (sustained virologic response) SVR-12; overall and by study site. A secondary product will be a lesson learned guide of recommendations for implementing a POD on-site test and treat program for dissemination beyond San Francisco.
Status | Completed |
Enrollment | 86 |
Est. completion date | December 29, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - =18 years of age - anti-HCV and HCV RNA positive, - interested in starting HCV treatment at the time of diagnosis - Women of childbearing potential engaged in sexual activity that could lead to pregnancy - must consent to use contraception and agree to pregnancy testing during treatment - If currently not enrolled in insurance, agree to assistance to enroll in insurance Exclusion Criteria: - HBsAg positive from pre-screening visit and no medically controlled hepatitis B virus (HBV) condition - History of hepatic decompensation (ascites, hepatic encephalopathy, or variceal hemorrhage). - Current use of medications that is not compatible with SOF/VEL use, according to current prescribing guidelines, including amiodarone or a proton pump inhibitor exceeding 20 mg of omeprazole equivalent. - Prior treatment with an NS5a based HCV treatment regimen with subsequent viral rebound. Participants who have clear HCV reinfection as defined by an HCV GT that is different from the original genotype may enroll. If genotype results are not available from the initial and subsequent HCV infection, the individual will not be enrolled unless participant can provide SVR-12 record confirming HCV cure. - Pregnancy or breastfeeding. - Life expectancy of < 12 months as assessed by study clinical health provider. - Late exclusion criteria: Participants with the following lab values at week 0 will be evaluated on a case by case basis for continuation of SOF/VEL at the week 2 visit - Albumin < 3.0 - Hemoglobin < 8.0 (women) and < 9.0 g/dl ( men) - Platelet count < 50,000 - creatinine (Cr) clearance (estimated by Cockcroft-Gault) < 30 ml/min - aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) > 10 x ULN - Total bilirubin > 1.5x ULN (for participants on atazanavir, > 3 x ULN), international normalized ratio (INR) > 1. 5 x ULN |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Gilead Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SVR-12 | The number and proportion attaining SVR12 after POD HCV treatment, overall,using a modified intention to treat analysis (participants taking one or more doses of SOF/VEL). | 24 weeks from the start of treatment | |
Primary | SVR-12, by project site | The number and proportion attaining SVR12 after POD HCV treatment, by site, using a modified intention to treat analysis (participants taking one or more doses of SOF/VEL). | 24 weeks from the start of treatment | |
Secondary | Time from HCV testing to treatment initiation | Time from HCV testing visit to treatment initiation | 24 weeks | |
Secondary | Time from HCV testing to treatment completion | Time from HCV testing visit to treatment completion | 24 weeks | |
Secondary | Time from HCV testing to SVR-12. | Time from HCV testing visit to SVR-12 | 24 weeks | |
Secondary | Treatment adherence | Adherence as estimated by pill count at 4-week intervals, week 4 HCV viral load, and self-disclosure treatment adherence. | 12 weeks | |
Secondary | Treatment adherence at 4 weeks | Adherence as estimated by pill count estimated as the average using self-report pill count taken divided by 28 pills. | 4 weeks from treatment initiation | |
Secondary | Treatment adherence at 8 weeks | Adherence as estimated by pill count estimated as the average using self-report pill count taken divided by 56 pills. | 8 weeks from treatment initiation | |
Secondary | Treatment adherence at 12 weeks | Adherence as estimated by pill count estimated as the average using self-report pill count taken divided by 84 pills. | 12 weeks from treatment initiation | |
Secondary | Treatment adherence | Adherence as estimated by HCV viral load test (PCR) at 4 weeks | 4 weeks from treatment initiation | |
Secondary | Treatment adherence | Adherence as estimated by HCV viral load test (PCR) at 12 weeks | 12 weeks from treatment initiation | |
Secondary | Acceptability: Number of persons who decline POD treatment | Number of persons who decline POD treatment | 1 day | |
Secondary | Acceptability: median age by declined | Comparison of median age by declined POD treatment group vs POD treatment initiate group. | 1 day | |
Secondary | Acceptability: percent female by declined | Comparison of percent female by declined POD treatment group vs POD treatment initiate group. | 1 day | |
Secondary | Acceptability: percent non-white race/ethnicity by | Comparison of percent non-white race/ethnicity by declined POD treatment group vs POD treatment initiate group. | 1 day | |
Secondary | Acceptability: percent homeless in past 30 days | Comparison of percent homeless in past 30 days by declined POD treatment group vs POD treatment initiate group. | 1 day | |
Secondary | Acceptability: percent injected drugs in past 30 days | Comparison of percent injected drugs in past 30 days by declined POD treatment group vs POD treatment initiate group. | 1 day | |
Secondary | Acceptability: percent jail/prison stay in past 30 days | Comparison of percent jail/prison stay in past 30 days by declined POD treatment group vs POD treatment initiate group. | 1 day |
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