A Phase 4 interventional study of Cepheid GeneXpert HCV Test and INSTI HIV - 1/2 Antibody in HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV) and HEPATITIS C (HCV), sponsored by Duke University. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Duke University · Phase 4, Interventional, and Diagnostic
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.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 1,280 is above the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Compared within Hepatitis B, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Nov 9, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Retreatment Inclusion Criteria:
Retreatment Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will complete standard local clinical practice for HCV, HIV, and HBV testing and for initiation of treatment of HCV.
Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] · Drug: Sofosbuvir/Velpatasvir/Voxilaprevir
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.
Device: Cepheid GeneXpert HCV Test · Diagnostic Test: INSTI HIV - 1/2 Antibody · Diagnostic Test: bioLytical Laboratories iStatis Hepatitis B Surface Antigen Test · Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] · Drug: Sofosbuvir/Velpatasvir/Voxilaprevir
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.
The bioLytical Laboratories INSTI HIV-1/HIV-2 Antibody test is a single-use rapid assay for the detection of antibodies to HIV-1/HIV-2. This test is conducted from a fingerstick using whole blood.
The iStatis Hepatitis B Surface Antigen test is a single use, rapid, lateral flow, in vitro qualitative immunoassay for the detection of Hepatitis B Surface Antigen in human EDTA-whole blood, fingerstick whole blood, serum, or plasma.
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.
Also known as: Direct acting antiviral
Drug pages: Sofosbuvir · Velpatasvir · Voxilaprevir
Sofosbuvir/Velpatasvir/Voxilaprevir will be provided to participants who experience a relapse of HCV, re-infection, or virologic failure based on point-of-care (POC) or standard of care (SOC) testing after completion of sofosbuvir/velpatasvir as part of the study.
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+).
Time frame: 24 weeks from study enrollment
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)
Time frame: Day 1
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.
Time frame: 12 weeks
Proportion of participants initiating direct-acting antiviral (DAA) therapy within 24 weeks of entry
HCV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].
Time frame: 24
Time from enrollment to treatment initiation
HCV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].
Time frame: up to 24 weeks
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.
Time frame: 24 weeks
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.
Time frame: 60 weeks
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.
Time frame: within 60 weeks
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.
Time frame: within 60 weeks
Proportion of participants with HCV RNA not detected based on dried blood spot at week 24 and week 60
HCV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].
Time frame: Week 24 and 60
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.
Time frame: 24 weeks of entry
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.
Time frame: 24 weeks of entry
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.
Time frame: 24 weeks of entry
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.
Time frame: 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
HIV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].
Time frame: Week 24 and 60
Time from enrollment to PrEP initiation
HIV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].
Time frame: up to 60 weeks
All cause and liver specific hospitalizations through week 60
Safety \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].
Time frame: 60 weeks
All cause and liver specific mortality through week 60
Safety \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].
Time frame: Week 60
On direct-acting antiviral (DAA) treatment serious suspected adverse events leading to discontinuation of sofosbuvir/velpatasvir
Safety \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].
Time frame: 60 weeks
Adverse maternal and fetal outcomes for those on direct-acting antiviral (DAA) at any time during pregnancy
Safety \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].
Time frame: up to 60 weeks
Adverse device effects related to study devices
Safety \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].
Time frame: up to 60 weeks
Adherence to direct-acting antiviral (DAA) therapy as measured by participant self-report
Time frame: 12 and 24 weeks
Health-related quality of life (EQ5D) and social functioning through week 60
Time frame: Week 60
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
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
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
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Jan 2027; primary completion for Nov 2030, 46 months later.
Of 47 non-industry phase 4 interventional studies under Hepatitis B, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 46 months is close to that.
Counting every sponsor, half of 63 studies reached it within 35 months; a quarter within 12 and three quarters within 59.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Jan 2027, on Oct 15, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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