[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636004":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":44,"centralContacts":28,"locations":28,"responsibleParty":48,"collaborators":50,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":28,"enrollmentInfo":83,"targetDuration":28,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":98,"whyStopped":28,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":28},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care (control arm)","ACTIVE_COMPARATOR","Participants will complete standard local clinical practice for HCV, HIV, and HBV testing and for initiation of treatment of HCV.",[13],"Drug: Sofosbuvir \u002F Velpatasvir Oral Tablet [Epclusa]",{"label":15,"type":16,"description":17,"interventionNames":18},"Single-visit POC test & treat (intervention arm)","EXPERIMENTAL","Sites randomized to the single-visit point-of-care test (POC) \\& treat arm will undergo fingerstick POC HCV RNA, HIV antibody\u002Fantigen, and HBsAg and for those with detectable HCV RNA, HCV treatment will be initiated.",[19,20,21,13],"Device: Cepheid GeneXpert HCV Test","Device: Abbott Determine HIV - 1\u002F2 Ag\u002FAb","Device: Abbott Determine HbsAg 2",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Cepheid GeneXpert HCV Test","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.",[15],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Abbott Determine HIV - 1\u002F2 Ag\u002FAb","Abbott Determine HIV - 1\u002F2 Ag\u002FAb 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.",[15],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Abbott Determine HbsAg 2","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.",[15],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Sofosbuvir \u002F Velpatasvir Oral Tablet [Epclusa]","Participants with detectable HCV RNA on Xpert test will receive sofosbuvir\u002Fvelpatasvir at the same visit as the POC test in the intervention arm. Participants in the SOC arm will receive sofosbuvir\u002Fvelpatasvir after standard of care testing and treatment assessment has been completed.",[15,9],[43],"Direct acting antiviral",[45],{"name":46,"affiliation":5,"role":47},"Susanna Naggie, MD, MHS","PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[51,53,55,57,60,62,64,67,70],{"name":52,"class":6},"Yale University",{"name":54,"class":6},"West Virginia University",{"name":56,"class":6},"University of San Diego",{"name":58,"class":59},"Cepheid","INDUSTRY",{"name":61,"class":59},"Gilead Sciences",{"name":63,"class":59},"Abbott",{"name":65,"class":66},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":68,"class":69},"Flinders University International Centre for Point-of-care Testing","UNKNOWN",{"name":71,"class":72},"Kirby Institute","OTHER_GOV","100636004","phase-4-combating-related-epidemics-in-hcv-100636004",false,"NCT07560046","Combating Related Epidemics in HCV","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","CREST","Inclusion Criteria:\n\n1. Can provide written informed consent or assent\n2. Minimum of 16 years of age\n3. Willing to undergo HIV, HCV, HBV testing\n4. Willing to undergo treatment for HCV and complete study activities\n\nExclusion Criteria:\n\n1. History of HCV treatment for current infection\n2. 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\n3. Contraindication for treatment with sofosbuvir\u002Fvelpatasvir due to allergy or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.\n4. 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\n5. 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\u002Fday of omeprazole (or equivalent) at time of study entry.\n\nRetreatment Inclusion Criteria:\n\n1. Completion of sofosbuvir\u002Fvelpatasvir treatment regimen as enrolled participant in CREST and willingness to receive retreatment. FIB-4 \\& CTP score available within 90-days of retreatment initiation.\n2. Meeting any of the below criteria during post-cessation treatment follow-up. Relapse, defined as HCV RNA \\\u003CLLOQ\u002FD (TD or TND) during and\u002For at end of treatment followed by HCV RNA \\>LLOQ\u002FD 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\u002FD 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\u002FD at any point after end of treatment (after week 24 visit) or during follow-up, not otherwise meeting definition of relapse or re-infection\n\nRetreatment Exclusion Criteria:\n\n1. 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.\n2. Pregnant or breast feeding at time of retreatment with sofosbuvir\u002Fvelpatasvir\u002Fvoxilaprevir.\n3. Contraindication for treatment with sofosbuvir\u002Fvelpatasvir (reinfection) or sofosbuvir\u002Fvelpatasvir\u002Fvoxilaprevir (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.\n4. 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\n5. 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\u002Fday of omeprazole (or equivalent) at time of study entry.","ALL","16 Years",{"count":84,"type":85},1280,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","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.",[91,92,93],"HIV - Human Immunodeficiency Virus","Hepatitis B Virus (HBV)","HEPATITIS C (HCV)",[95,96,97,79],"Hepatitis C","Hepatitis B","HIV","NOT_YET_RECRUITING","2026-04-30",{"date":101,"type":102},"2026-05-05","ACTUAL",{"date":104,"type":85},"2026-08-01",{"date":106,"type":85},"2030-12-30",{"name":5,"class":6}]