Health TrialsbyHealthPanel

Combating Related Epidemics in HCV

ConditionsHIV - Human Immunodeficiency VirusHepatitis B Virus (HBV)HEPATITIS C (HCV)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,280 Participants
are divided into 2 treatment groups
Group A: Standard of Care (control arm)Active comparator 1 intervention
Group B: Single-visit POC test & treat (intervention arm)Experimental treatment 4 interventions

Trial outcomes

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.

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

Secondary outcomes

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)

Time frame
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.

Time frame
12 weeks
3

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

HCV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].

Time frame
24
4

Time from enrollment to treatment initiation

HCV related \[all outcomes are assessed in the primary analysis population (as defined by dried blood spot testing at screening) and compared between intervention and SOC arms\].

Time frame
up to 24 weeks

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Yale University

Collaborator

West Virginia University

Collaborator

University of San Diego

Collaborator

Cepheid

Collaborator

Gilead Sciences

Collaborator

Abbott

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Flinders University International Centre for Point-of-care Testing

Collaborator

Kirby Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: