AzTrials
AzTrials

HIV - Human Immunodeficiency VirusPhase 4CRESTNCT07560046

Combating Related Epidemics in HCV

A Phase 4 study testing Cepheid GeneXpert HCV Test, Abbott Determine HIV - 1/2 Ag/Ab and Abbott Determine HbsAg 2 in people with HIV - Human Immunodeficiency Virus and Hepatitis B Virus (HBV), run by Duke University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Cepheid GeneXpert HCV Test, Abbott Determine HIV - 1/2 Ag/Ab and Abbott Determine HbsAg 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,280 participants
Where
No sites listed yet
Study dates
20 Jan 2027to 30 Dec 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 14Show fewer
  • 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.

About this study

Official 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

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.

Being tested
Cepheid GeneXpert HCV Test, Abbott Determine HIV - 1/2 Ag/Ab, Abbott Determine HbsAg 2, Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
Keywords
Hepatitis C, Hepatitis B, HIV, CREST
Medical subject headings
Acquired Immunodeficiency Syndrome, Hepatitis B, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cepheid GeneXpert HCV TestDevice

    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/AbDevice

    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 2Device

    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

    Also called Direct acting antiviral

    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.

Study groups in NCT07560046
Study groupRoleWhat they receive
Standard of Care (control arm)Active comparatorParticipants will complete standard local clinical practice for HCV, HIV, and HBV testing and for initiation of treatment of HCV.
Receives: Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
Single-visit POC test & treat (intervention arm)ExperimentalSites 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.
Receives: Device: Cepheid GeneXpert HCV Test; Device: Abbott Determine HIV - 1/2 Ag/Ab; Device: Abbott Determine HbsAg 2; Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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+).

    Measured: 24 weeks from study enrollment

Secondary outcomes (20)

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

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

    Measured: Day 1

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

    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.

    Measured: 12 weeks

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

    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].

    Measured: 24

  4. Time from enrollment to treatment initiation

    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].

    Measured: up to 24 weeks

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

    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.

    Measured: 24 weeks

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

    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.

    Measured: 60 weeks

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

    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.

    Measured: within 60 weeks

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

    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.

    Measured: within 60 weeks

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

    Measured: Week 24 and 60

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

    Measured: 24 weeks of entry

  11. Proportion of participants who initiate PrEP within 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.

    Measured: 24 weeks of entry

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

    Measured: 24 weeks of entry

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

    Measured: 24 weeks of entry

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

    Measured: Week 24 and 60

  15. Time from enrollment to PrEP initiation

    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].

    Measured: up to 60 weeks

  16. All cause and liver specific hospitalizations through 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].

    Measured: 60 weeks

  17. All cause and liver specific mortality through 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].

    Measured: Week 60

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

    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].

    Measured: 60 weeks

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

    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].

    Measured: up to 60 weeks

  20. Adverse device effects related to study devices

    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].

    Measured: up to 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2026
  2. Study start20 Jan 2027 (estimated)
  3. Primary completion30 Nov 2030 (estimated)
  4. Study completion30 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07560046
Sponsor's protocol ID
Pro00118863
Other IDs
1U01AI195193
Acronym
CREST
Status last verified
Apr 2026
First submitted
2 Apr 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Solomon SS, Wagner-Cardoso S, Smeaton L, Sowah LA, Wimbish C, Robbins G, Brates I, Scello C, Son A, Avihingsanon A, Linas B, Anthony D, Nunes EP, Kliemann DA, Supparatpinyo K, Kityo C, Tebas P, Bennet JA, Santana-Bagur J, Benson CA, Van Schalkwyk M, Cheinquer N, Naggie S, Wyles D, Sulkowski M. A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):307-317. doi: 10.1016/S2468-1253(21)00397-6. Epub 2022 Jan 10.

    PubMed 35026142

  • Sheehan Y, Cunningham EB, Cochrane A, Byrne M, Brown T, McGrath C, Lafferty L, Tedla N, Dore GJ, Lloyd AR, Grebely J. A 'one-stop-shop' point-of-care hepatitis C RNA testing intervention to enhance treatment uptake in a reception prison: The PIVOT study. J Hepatol. 2023 Sep;79(3):635-644. doi: 10.1016/j.jhep.2023.04.019. Epub 2023 Apr 26.

    PubMed 37116714

  • Coyle C, Moorman AC, Bartholomew T, Klein G, Kwakwa H, Mehta SH, Holtzman D. The Hepatitis C Virus Care Continuum: Linkage to Hepatitis C Virus Care and Treatment Among Patients at an Urban Health Network, Philadelphia, PA. Hepatology. 2019 Aug;70(2):476-486. doi: 10.1002/hep.30501. Epub 2019 Mar 26.

    PubMed 30633811

  • Mahase E. Hepatitis C: Egypt makes "unprecedented progress" towards elimination. BMJ. 2023 Oct 10;383:2353. doi: 10.1136/bmj.p2353. No abstract available.

    PubMed 37816531

  • Dore GJ. Elimination of hepatitis C in Australia by 2030: a decade and counting. Aust Prescr. 2021 Apr;44(2):36-37. doi: 10.18773/austprescr.2021.003. Epub 2021 Apr 1. No abstract available.

    PubMed 33911328

  • Eckhardt B, Mateu-Gelabert P, Aponte-Melendez Y, Fong C, Kapadia S, Smith M, Edlin BR, Marks KM. Accessible Hepatitis C Care for People Who Inject Drugs: A Randomized Clinical Trial. JAMA Intern Med. 2022 May 1;182(5):494-502. doi: 10.1001/jamainternmed.2022.0170.

    PubMed 35285851

  • Eckhardt B, Kapadia SN, Mateu-Gelabert P, Pai M, Fong C, Aponte-Melendez Y, Marks KM. Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial. Open Forum Infect Dis. 2022 May 7;9(7):ofac225. doi: 10.1093/ofid/ofac225. eCollection 2022 Jul.

    PubMed 35821731

  • Brooks R, Wegener M, Freeman B, Fowles C, Madden LM, Tetrault JM, Nichols L, Altice FL, Villanueva M. Improving HIV and HCV Testing in Substance Use Disorder Programs (SUDs) That Provide Medications for Opiate Use Disorder (MOUD): Role of Addressing Barriers and Implementing Universal and Site-Specific Approaches. Health Promot Pract. 2023 Sep;24(5):1018-1028. doi: 10.1177/15248399231169791. Epub 2023 Jul 13.

    PubMed 37439759

  • Sivakumar A, Madden L, DiDomizio E, Eller A, Villanueva M, Altice FL. Treatment of Hepatitis C virus among people who inject drugs at a syringe service program during the COVID-19 response: The potential role of telehealth, medications for opioid use disorder and minimal demands on patients. Int J Drug Policy. 2022 Mar;101:103570. doi: 10.1016/j.drugpo.2021.103570. Epub 2021 Dec 20.

    PubMed 34954493

  • Westgard LK, Sato T, Bradford WS, Eaton EF, Pilcher F, Hale AJ, Singh D, Martin M, Appa AA, Meyer JP, Weimer MB, Barakat LA, Felsen UR, Akiyama MJ, Ridgway JP, Grussing ED, Thakarar K, White A, Mutelayi J, Krsak M, Montague BT, Nijhawan A, Balakrishnan H, Marks LR, Wurcel AG. National HIV and HCV Screening Rates for Hospitalized People who Use Drugs Are Suboptimal and Heterogeneous Across 11 US Hospitals. Open Forum Infect Dis. 2024 Apr 16;11(5):ofae204. doi: 10.1093/ofid/ofae204. eCollection 2024 May.

    PubMed 38746950

  • Shrestha R, Karki P, Altice FL, Huedo-Medina TB, Meyer JP, Madden L, Copenhaver M. Correlates of willingness to initiate pre-exposure prophylaxis and anticipation of practicing safer drug- and sex-related behaviors among high-risk drug users on methadone treatment. Drug Alcohol Depend. 2017 Apr 1;173:107-116. doi: 10.1016/j.drugalcdep.2016.12.023. Epub 2017 Feb 2.

    PubMed 28214391

  • McFarland W, Lin J, Santos GM, Arayasirikul S, Raymond HF, Wilson E. Low PrEP Awareness and Use Among People Who Inject Drugs, San Francisco, 2018. AIDS Behav. 2020 May;24(5):1290-1293. doi: 10.1007/s10461-019-02682-7.

    PubMed 31563984

  • Di Martino V, Rufat P, Boyer N, Renard P, Degos F, Martinot-Peignoux M, Matheron S, Le Moing V, Vachon F, Degott C, Valla D, Marcellin P. The influence of human immunodeficiency virus coinfection on chronic hepatitis C in injection drug users: a long-term retrospective cohort study. Hepatology. 2001 Dec;34(6):1193-9. doi: 10.1053/jhep.2001.29201.

    PubMed 11732009

  • Escudero DJ, Lurie MN, Mayer KH, King M, Galea S, Friedman SR, Marshall BDL. The risk of HIV transmission at each step of the HIV care continuum among people who inject drugs: a modeling study. BMC Public Health. 2017 Jul 25;17(1):614. doi: 10.1186/s12889-017-4528-9.

    PubMed 28738861

  • Skarbinski J, Rosenberg E, Paz-Bailey G, Hall HI, Rose CE, Viall AH, Fagan JL, Lansky A, Mermin JH. Human immunodeficiency virus transmission at each step of the care continuum in the United States. JAMA Intern Med. 2015 Apr;175(4):588-96. doi: 10.1001/jamainternmed.2014.8180.

    PubMed 25706928

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cepheid GeneXpert HCV Test, Abbott Determine HIV - 1/2 Ag/Ab and Abbott Determine HbsAg 2 in people with HIV - Human Immunodeficiency Virus and Hepatitis B Virus (HBV), run by Duke University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07560046, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in