Combating Related Epidemics in 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
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
Treatments tested in this trial
- Cepheid GeneXpert HCV Test
- Abbott Determine HIV - 1/2 Ag/Ab
- Abbott Determine HbsAg 2
- Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
Treatment groups
1,280 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
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