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NCT Number: NCT07560046

Combating Related Epidemics in HCV

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.

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Key information

Conditions

HIV - Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Flaviviridae Infections Genital Diseases HEPATITIS C (HCV) HIV Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B Virus (HBV) Hepatitis C Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of HCV treatment for current infection
  • 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
  • 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.
  • 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
  • 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:

  • 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.
  • 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:

  • 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.
  • Pregnant or breast feeding at time of retreatment with sofosbuvir/velpatasvir/voxilaprevir.
  • 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.
  • 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
  • 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.

Treatment and study plan

Cepheid GeneXpert HCV Test

Device

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

Device

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.

Abbott Determine HbsAg 2

Device

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.

Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]

Drug

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.

Other names: Direct acting antiviral

Primary outcomes

  1. 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.

    Time frame: 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+).

Secondary outcomes

  1. Proportion of participants initiating same-visit direct-acting antiviral (DAA) treatment following enrollment (intervention arm only)

    Time frame: Day 1

    Proportion of participants initiating same-visit DAA treatment following enrollment (intervention arm only)

  2. Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 weeks of entry

    Time frame: 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.

  3. Proportion of participants initiating direct-acting antiviral (DAA) therapy within 24 weeks of entry

    Time frame: 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].

  4. Time from enrollment to treatment initiation

    Time frame: 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].

  5. Proportion of participants completing direct-acting antiviral (DAA) therapy within 24 weeks of entry

    Time frame: 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.

  6. Proportion of participants achieving sustained virologic response (SVR4+) within 60 weeks of entry

    Time frame: 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.

  7. Cumulative incidence of HCV reinfection following sustained virologic response (SVR4+) within 60 weeks of entry

    Time frame: 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.

  8. Cumulative retreatment following sustained virologic response (SVR4+) or relapse within 60 weeks of entry

    Time frame: 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.

  9. Proportion of participants with HCV RNA not detected based on dried blood spot at week 24 and week 60

    Time frame: 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].

  10. Proportion of participants who have received any HIV test result within 24 weeks of entry

    Time frame: 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.

  11. Proportion of participants who initiate PrEP within 24 weeks of entry

    Time frame: 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.

  12. Proportion of participants with HIV who commence direct-acting antiviral (DAA) therapy within 24 weeks of entry

    Time frame: 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.

  13. Proportion of participants with HIV not on antiretroviral therapy (ART) at screening who commence ART within 24 weeks of entry

    Time frame: 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.

  14. Proportion of participants with HIV on antiretroviral therapy (ART) at screening who remain on ART at week 24 and week 60

    Time frame: 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].

  15. Time from enrollment to PrEP initiation

    Time frame: 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].

  16. All cause and liver specific hospitalizations through week 60

    Time frame: 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].

  17. All cause and liver specific mortality through week 60

    Time frame: 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].

  18. On direct-acting antiviral (DAA) treatment serious suspected adverse events leading to discontinuation of sofosbuvir/velpatasvir

    Time frame: 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].

  19. Adverse maternal and fetal outcomes for those on direct-acting antiviral (DAA) at any time during pregnancy

    Time frame: 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].

  20. Adverse device effects related to study devices

    Time frame: 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].

Other outcomes

  1. Adherence to direct-acting antiviral (DAA) therapy as measured by participant self-report

    Time frame: 12 and 24 weeks

  2. Health-related quality of life (EQ5D) and social functioning through week 60

    Time frame: Week 60

  3. Changes in health-related quality of life (EQ5D) from baseline to week 24 and week 60

    Time frame: from baseline to Week 24 and 60

  4. Among participants pregnant at time of enrollment: Proportion of participants initiating direct-acting antiviral (DAA) therapy within 12 and 24 weeks of entry

    Time frame: Weeks 12 and 24

  5. 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

    Time frame: Week 24 and 60

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CREST

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 30, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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