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Combating Related Epidemics in HCV (CREST)

30. april 2026 opdateret af: Duke University

Combating Related Epidemics in HCV Through Simplified Testing and Treatment. A Cluster Randomized Trial of Point-of-care Hepatitis C Testing and Treatment Among Key Populations

This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm). 1:1 randomization occurs at the site level.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1280

Fase

  • Fase 4

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Can provide written informed consent or assent
  2. Minimum of 16 years of age
  3. Willing to undergo HIV, HCV, HBV testing
  4. Willing to undergo treatment for HCV and complete study activities

Exclusion Criteria:

  1. History of HCV treatment for current infection
  2. Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, or clinical evidence per the site PI
  3. Contraindication for treatment with sofosbuvir/velpatasvir due to allergy or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.
  4. History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI
  5. Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent). NOTE: PPI can be discontinued or dose reduced to 20 mg/day of omeprazole (or equivalent) at time of study entry.

Retreatment Inclusion Criteria:

  1. Completion of sofosbuvir/velpatasvir treatment regimen as enrolled participant in CREST and willingness to receive retreatment. FIB-4 & CTP score available within 90-days of retreatment initiation.
  2. Meeting any of the below criteria during post-cessation treatment follow-up. Relapse, defined as HCV RNA <LLOQ/D (TD or TND) during and/or at end of treatment followed by HCV RNA >LLOQ/D or target detected based on qualitative POC test at any time point from end of treatment to 12 weeks after end of treatment OR Re-infection, defined as meeting the primary outcome criteria for SVR4+ followed by HCV RNA >LLOQ/D or target detected based on qualitative POC test at any time point beyond meeting SVR4+ OR Post-treatment virologic failure, defined as HCV RNA >LLOQ/D at any point after end of treatment (after week 24 visit) or during follow-up, not otherwise meeting definition of relapse or re-infection

Retreatment Exclusion Criteria:

  1. Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, clinical evidence per the site PI, or by CTP score ≥7.
  2. Pregnant or breast feeding at time of retreatment with sofosbuvir/velpatasvir/voxilaprevir.
  3. Contraindication for treatment with sofosbuvir/velpatasvir (reinfection) or sofosbuvir/velpatasvir/voxilaprevir (relapse or virologic failure) due to FDA package insert, allergy, or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.
  4. History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI
  5. Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent.). NOTE: PPI can be discontinued or dose reduced to 20 mg/day of omeprazole (or equivalent) at time of study entry.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard of Care (control arm)
Participants will complete standard local clinical practice for HCV, HIV, and HBV testing and for initiation of treatment of HCV.
Medicin: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
Participants with detectable HCV RNA on Xpert test will receive sofosbuvir/velpatasvir at the same visit as the POC test in the intervention arm. Participants in the SOC arm will receive sofosbuvir/velpatasvir after standard of care testing and treatment assessment has been completed.
Andre navne:
  • Direct acting antiviral
Eksperimentel: Single-visit POC test & treat (intervention arm)
Sites randomized to the single-visit point-of-care test (POC) & treat arm will undergo fingerstick POC HCV RNA, HIV antibody/antigen, and HBsAg and for those with detectable HCV RNA, HCV treatment will be initiated.
Medicin: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
Participants with detectable HCV RNA on Xpert test will receive sofosbuvir/velpatasvir at the same visit as the POC test in the intervention arm. Participants in the SOC arm will receive sofosbuvir/velpatasvir after standard of care testing and treatment assessment has been completed.
Andre navne:
  • Direct acting antiviral
Enhed: Cepheid GeneXpert HCV Test
Cepheid Xpert HCV Test, performed on the GeneXpert Xpress system, in an automated in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of Hep C (HCV) RNA in human fingerstick.
Enhed: Abbott Determine HIV - 1/2 Ag/Ab
Abbott Determine HIV - 1/2 Ag/Ab combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of Human Immunodeficiency Virus type-1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV type-1 and type-2 in fingerstick. Intended use is point-of-care test to aid in the diagnosis of infection.
Enhed: Abbott Determine HbsAg 2
Determine HBsAg 2 is an in vitro, visually read, qualitative immunoassay for detection of Hepatitis B Surface Antigen (HBsAg) in human fingerstick. The test is intended as an aid to detect HBAg from infected individuals.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants who complete the Hepatitis C Virus (HCV) care cascade within 24 weeks of study entry in intervention versus Standard of Care (SOC) arm.
Tidsramme: 24 weeks from study enrollment
Proportion of participants in the primary analysis population (as defined as detectable HCV RNA on dried blood spot testing at screening) who complete the HCV care cascade within 24 weeks of study entry in intervention versus SOC arm. Completion of the care cascade will be defined as HCV RNA<lower limit of quantification/detection (LLOQ/D) at a minimum of 4 weeks post-cessation of direct-acting antiviral (DAA) therapy sustained virologic response (SVR4+).
24 weeks from study enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time from enrollment to treatment initiation
Tidsramme: up to 24 weeks
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
up to 24 weeks
Proportion of participants with HCV RNA not detected based on dried blood spot at week 24 and week 60
Tidsramme: Week 24 and 60
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
Week 24 and 60
Proportion of participants who have received any HIV test result within 24 weeks of entry
Tidsramme: 24 weeks of entry
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
24 weeks of entry
Proportion of participants who initiate PrEP within 24 weeks of entry
Tidsramme: 24 weeks of entry
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
24 weeks of entry
Time from enrollment to PrEP initiation
Tidsramme: up to 60 weeks
HIV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
up to 60 weeks
All cause and liver specific hospitalizations through week 60
Tidsramme: 60 weeks
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
60 weeks
All cause and liver specific mortality through week 60
Tidsramme: Week 60
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
Week 60
Adverse device effects related to study devices
Tidsramme: up to 60 weeks
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
up to 60 weeks
Proportion of participants initiating same-visit direct-acting antiviral (DAA) treatment following enrollment (intervention arm only)
Tidsramme: Day 1
Proportion of participants initiating same-visit DAA treatment following enrollment (intervention arm only)
Day 1
Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 weeks of entry
Tidsramme: 12 weeks
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
12 weeks
Proportion of participants initiating direct-acting antiviral (DAA) therapy within 24 weeks of entry
Tidsramme: 24
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
24
Proportion of participants completing direct-acting antiviral (DAA) therapy within 24 weeks of entry
Tidsramme: 24 weeks
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
24 weeks
Proportion of participants achieving sustained virologic response (SVR4+) within 60 weeks of entry
Tidsramme: 60 weeks
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
60 weeks
Cumulative incidence of HCV reinfection following sustained virologic response (SVR4+) within 60 weeks of entry
Tidsramme: within 60 weeks
HCV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
within 60 weeks
Cumulative retreatment following sustained virologic response (SVR4+) or relapse within 60 weeks of entry
Tidsramme: within 60 weeks
HCV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms]. This analysis for retreatment is limited to participants 18 years old and older.
within 60 weeks
Proportion of participants with HIV who commence direct-acting antiviral (DAA) therapy within 24 weeks of entry
Tidsramme: 24 weeks of entry
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
24 weeks of entry
Proportion of participants with HIV not on antiretroviral therapy (ART) at screening who commence ART within 24 weeks of entry
Tidsramme: 24 weeks of entry
HIV related outcomes are assessed in the primary analysis population (as defined by entry dried blood spot testing at screening) and compared between intervention and SOC arms.
24 weeks of entry
Proportion of participants with HIV on antiretroviral therapy (ART) at screening who remain on ART at week 24 and week 60
Tidsramme: Week 24 and 60
HIV related [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
Week 24 and 60
On direct-acting antiviral (DAA) treatment serious suspected adverse events leading to discontinuation of sofosbuvir/velpatasvir
Tidsramme: 60 weeks
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
60 weeks
Adverse maternal and fetal outcomes for those on direct-acting antiviral (DAA) at any time during pregnancy
Tidsramme: up to 60 weeks
Safety [all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms].
up to 60 weeks

Andre resultatmål

Resultatmål
Tidsramme
Health-related quality of life (EQ5D) and social functioning through week 60
Tidsramme: Week 60
Week 60
Changes in health-related quality of life (EQ5D) from baseline to week 24 and week 60
Tidsramme: from baseline to Week 24 and 60
from baseline to Week 24 and 60
Among participants pregnant at time of enrollment: Proportion of participants completing DAA therapy within 24 weeks of entry and achieving SVR4+ within 60 weeks of entry
Tidsramme: Week 24 and 60
Week 24 and 60
Adherence to direct-acting antiviral (DAA) therapy as measured by participant self-report
Tidsramme: 12 and 24 weeks
12 and 24 weeks
Among participants pregnant at time of enrollment: Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 and 24 weeks of entry
Tidsramme: Weeks 12 and 24
Weeks 12 and 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Duke University

Samarbejdspartnere

National Institute of Allergy and Infectious Diseases (NIAID)
Yale University
Gilead Sciences
Abbott
Kirby Institute
West Virginia University
Cepheid
University of San Diego
Flinders University International Centre for Point-of-care Testing

Efterforskere

  • Ledende efterforsker: Susanna Naggie, MD, MHS, Duke University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

30. november 2030

Studieafslutning (Anslået)

30. december 2030

Datoer for studieregistrering

Først indsendt

2. april 2026

Først indsendt, der opfyldte QC-kriterier

23. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00118863
  • 1U01AI195193 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HEPATITIS C (HCV)

Kliniske forsøg med Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]

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