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Combating Related Epidemics in HCV (CREST)

30. dubna 2026 aktualizováno: 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.

Přehled studie

Typ studie

Intervenční

Zápis (Odhadovaný)

1280

Fáze

  • Fáze 4

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Diagnostický
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
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.
Ostatní jména:
  • Direct acting antiviral
Experimentální: 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.
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.
Ostatní jména:
  • Direct acting antiviral
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.
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.
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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.
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time from enrollment to treatment initiation
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Časové okno
Health-related quality of life (EQ5D) and social functioning through week 60
Časové okno: Week 60
Week 60
Changes in health-related quality of life (EQ5D) from baseline to week 24 and week 60
Časové okno: 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
Časové okno: Week 24 and 60
Week 24 and 60
Adherence to direct-acting antiviral (DAA) therapy as measured by participant self-report
Časové okno: 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
Časové okno: Weeks 12 and 24
Weeks 12 and 24

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

30. listopadu 2030

Dokončení studie (Odhadovaný)

30. prosince 2030

Termíny zápisu do studia

První předloženo

2. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

23. dubna 2026

První zveřejněno (Aktuální)

30. dubna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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