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The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study (NOW)

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ClinicalTrials.gov Identifier: NCT03987503
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Epclusa (SOF/VEL) Drug: Standard of care Device: Fibroscan® 430 Mini Plus Phase 4

Detailed Description:

This study is a non-randomized interventional study.

NOW is an open-label study evaluating the feasibility, acceptability, and effectiveness of an accelerated community-based treatment program of SOF/VEL x 12 weeks started at time of chronic HCV diagnosis (intervention).

The purpose of the proposed study is to assess the feasibility, acceptability and effectiveness of accelerated initiation of commercially available direct-acting antiviral (DAA) therapy targeting socially marginalized communities (e.g., medically underserved, homeless, people actively injecting drugs). The proposed study will be carried out at two community sites that perform HCV testing: (a) fixed community site and (b) community mobile site. The fixed site is located in the Tenderloin Neighborhood of San Francisco: The Quaker Meeting House (QMH). The QMH is the current location for an established drop-in center for young adult (< 30 years old) people who inject drugs, a group at highest risk for acquiring new HCV infection but representing a group with the lowest engagement in HCV treatment. The QMH site is complete with two phlebotomy stations, centrifuge, clinical exam station, interview rooms, and office space. The QMH research site will prioritize study enrollment for young adult people who inject drugs (PWID). The community mobile site (DeLIVER Van) is situated in a mobile van; a 145 sqft space equipped with a phlebotomy station, clinical exam table, centrifuge, and portable Fibroscan® 430 Mini Plus. The DeLIVER Van will serve two neighborhoods in San Francisco with high HCV burden but few community-based medical service organizations: the Bayview neighborhood and Outer Mission neighborhood.

The investigators will (1) implement new tools, notably FIBROSCANS, to measure fibrosis in an at-risk group (HCV positive patients); (2) implement a new standard of care, treatment on-demand in an at-risk group (HCV positive active drug users); (3) assess the feasibility and acceptability of expanding standard of care into non-clinical settings.

At study entry, participants will undergo a combined eligibility screening/entry visit, which includes HCV testing (antibody and RNA), rapid anti-HIV test, and HBsAG (hepatitis B virus surface antigen) testing and consent for medical record linkage. If HCV RNA reactive, participants are offered enrollment into the treatment cohort and provided 2 week supply of SOF/VEL (provided by Gilead as part of the NOW Study) upon completion of a clinical evaluation, baseline survey, and venipuncture for baseline labs. If the participant is actively insured, the study investigators will obtain insurance-authorized SOF/VEL to complete the remainder of the 12 week treatment course. If the participant is not actively insured, the study team will assist with insurance acquisition and subsequently obtain insurance-authorized SOF/VEL to complete the remainder of the 12 week treatment course. For any participants, if insurance-authorized SOF/VEL is delayed beyond the initial 2 week study-provided SOF/VEL, additional supplies of SOF/VEL as needed to ensure an uninterrupted 12 week treatment course. Participants will return every 2 weeks during treatment (12 week course) for medication dispensation and study visit activities. And for two post-treatment visits for clinical monitoring (e.g., HCV RNA testing) and research activities.

Study participants in the intervention study (cohort): Chronic HCV (anti-HCV positive and HCV RNA positive) men and women ages ≥18 years newly diagnosed or re-engaged in care at a fixed or mobile community-based site. Participants should be HBsAg negative, have no known history of decompensated cirrhosis or end stage renal disease, not be pregnant or breastfeeding, and not be taking medications that are contraindicated with SOF/VEL.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 29, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C

Arm Intervention/treatment
Experimental: at Point-of-Diagnosis HCV treatment
At the point of HCV infection diagnosis, (HCV RNA positive and anti-HCV positive) individuals who meet eligibility criteria and elect to start HCV treatment at the same visit and monitored at two-week intervals at the community-site.
Drug: Epclusa (SOF/VEL)
a trained physician will provide research participants with two-week supply of SOF/VEL. Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks. The initial 2-week supply is provided by Gilead Sciences and will be dispensed to participants upon enrollment. Prescriptions and insurance prior authorizations for SOF/VEL will be submitted by the study pharmacist though the UCSF Specialty Pharmacy. The study team will be notified once insurance-authorized drug is available and will bring participants' medication in 2 supplies to the study site prior to study visits.

Device: Fibroscan® 430 Mini Plus

Trained research staff will measure participants liver stiffness using liver ultrasonographic elastography. Research staff place ultrasound gel directly on participant's skin on the area of the torso. Research staff will position the participant's body on the exam table to assure the liver can be located, placing the small probe on the body's surface (skin with gel) and begin recording images of the participant's liver.

The procedure will take 15-30 minutes, depending on the ease with which the research staff is able to accurately locate the participant's liver.

Results from the FibroScan will be discussed with a trained provider.

Other Name: Fibroscan

Active Comparator: Passive observation
Participants who test positive for HCV chronic infection (HCV RNA positive, and anti-HCV positive) but elect to not enroll in the intervention arm. Electronic medical record data will be reviewed for up to 2 years for HCV related care information (e.g., HCV treatment start date, end date, SVR-12).
Drug: Standard of care
Standard of HCV care provided by medical care provider




Primary Outcome Measures :
  1. SVR-12 [ Time Frame: 24 weeks from the start of treatment ]
    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).

  2. SVR-12, by project site [ Time Frame: 24 weeks from the start of treatment ]
    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).


Secondary Outcome Measures :
  1. Time from HCV testing to treatment initiation [ Time Frame: 24 weeks ]
    Time from HCV testing visit to treatment initiation

  2. Time from HCV testing to treatment completion [ Time Frame: 24 weeks ]
    Time from HCV testing visit to treatment completion

  3. Time from HCV testing to SVR-12. [ Time Frame: 24 weeks ]
    Time from HCV testing visit to SVR-12

  4. Treatment adherence [ Time Frame: 12 weeks ]
    Adherence as estimated by pill count at 4-week intervals, week 4 HCV viral load, and self-disclosure treatment adherence.

  5. Treatment adherence at 4 weeks [ Time Frame: 4 weeks from treatment initiation ]
    Adherence as estimated by pill count estimated as the average using self-report pill count taken divided by 28 pills.

  6. Treatment adherence at 8 weeks [ Time Frame: 8 weeks from treatment initiation ]
    Adherence as estimated by pill count estimated as the average using self-report pill count taken divided by 56 pills.

  7. Treatment adherence at 12 weeks [ Time Frame: 12 weeks from treatment initiation ]
    Adherence as estimated by pill count estimated as the average using self-report pill count taken divided by 84 pills.

  8. Treatment adherence [ Time Frame: 4 weeks from treatment initiation ]
    Adherence as estimated by HCV viral load test (PCR) at 4 weeks

  9. Treatment adherence [ Time Frame: 12 weeks from treatment initiation ]
    Adherence as estimated by HCV viral load test (PCR) at 12 weeks

  10. Acceptability: Number of persons who decline POD treatment [ Time Frame: 1 day ]
    Number of persons who decline POD treatment

  11. Acceptability: median age by declined [ Time Frame: 1 day ]
    Comparison of median age by declined POD treatment group vs POD treatment initiate group.

  12. Acceptability: percent female by declined [ Time Frame: 1 day ]
    Comparison of percent female by declined POD treatment group vs POD treatment initiate group.

  13. Acceptability: percent non-white race/ethnicity by [ Time Frame: 1 day ]
    Comparison of percent non-white race/ethnicity by declined POD treatment group vs POD treatment initiate group.

  14. Acceptability: percent homeless in past 30 days [ Time Frame: 1 day ]
    Comparison of percent homeless in past 30 days by declined POD treatment group vs POD treatment initiate group.

  15. Acceptability: percent injected drugs in past 30 days [ Time Frame: 1 day ]
    Comparison of percent injected drugs in past 30 days by declined POD treatment group vs POD treatment initiate group.

  16. Acceptability: percent jail/prison stay in past 30 days [ Time Frame: 1 day ]
    Comparison of percent jail/prison stay in past 30 days by declined POD treatment group vs POD treatment initiate group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987503


Contacts
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Contact: Meghan D Morris, PhD 415-476-5822 Meghan.Morris@ucsf.edu
Contact: Jennifer Price, MD 415-502-1429 Jennifer.Price@ucsf.edu

Locations
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United States, California
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94153
Contact: Meghan D Morris, PhD    415-476-5822    Meghan.Morris@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Gilead Sciences
Investigators
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Principal Investigator: Meghan D Morris, PhD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03987503     History of Changes
Other Study ID Numbers: IN-US-342-5516
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Summary statistics of primary and secondary outcome data and overall sample demographics (e.g., gender, age, ethnicity/race) will be shared with researchers through annual conference presentations and final results related to the study aims will be disseminated via peer-reviewed manuscripts.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of California, San Francisco:
People who inject drugs
Homeless
Community-based testing and treatment

Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents