[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600514":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":53,"studyPopulation":45,"armGroups":54,"interventions":68,"overallOfficials":45,"centralContacts":86,"locations":45,"responsibleParty":95,"collaborators":97,"id":111,"slug":45,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":45,"enrollmentInfo":119,"targetDuration":45,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":131,"whyStopped":45,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":45},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Effectiveness of ACCESS+ strategy","% of anti-HCV positive patients at enrolment who were correctly managed (classified as follows): Success if either one of the following statement is reached 'baseline HCV RNA negative and informed of this result' or 'baseline HCV RNA positive, treated and HCV RNA negative 24 weeks after start of treatment' Failure in the other situations including 'baseline HCV RNA not tested', 'baseline HCV RNA negative but not informed of this result', 'baseline HCV RNA positive and untreated', 'baseline HCV RNA positive, treated and HCV RNA positive or not tested 24 weeks after start of treatment', and 'missing data'","12 weeks after the end of treatment",[14,18,21,24,27,30,33,36,39,42],{"measure":15,"description":16,"timeFrame":17},"HCV cascade (HCV RNA Test) of care between both strategies","% of anti-HCV positive patients who had an HCV RNA test","12 weeks after end of treatment",{"measure":19,"description":20,"timeFrame":17},"HCV Cascade (HCV RNA positive) of care between both strategies","% of anti-HCV positive patients who were HCV RNA positive",{"measure":22,"description":23,"timeFrame":17},"HCV Cascade (communication of HCV RNA Status) of care between the two strategies","% of anti-HCV positive patients who were aware of HCV RNA status",{"measure":25,"description":26,"timeFrame":17},"HCV Cascade (start of treatment) of care between the two strategies","% of HCV RNA positive patients who started direct-acting antiviral (DAA) treatment",{"measure":28,"description":29,"timeFrame":12},"HCV Cascade (treatment completed) of care between the two strategies","% of HCV RNA positive patients who completed the treatment; % of HCV RNA positive patients who were cured",{"measure":31,"description":32,"timeFrame":12},"HCV Cascade (patients cured) of care between the two strategies","% of HCV RNA positive patients who were cured",{"measure":34,"description":35,"timeFrame":17},"Patient-reported outcomes between both strategies","Barriers to HCV testing and treatment reported by patients and healthcare workers through qualitative interviews",{"measure":37,"description":38,"timeFrame":17},"Patient-reported outcomes (quality of life) between both strategies","Changes in health-related quality of life in Short Form-12 scale (SF-12), giving a physical and mental health summary of the participant",{"measure":40,"description":41,"timeFrame":17},"Patient-reported outcomes (fatigue) between both strategies","Changes in fatigue reported in Fatigue scale (scale graduated from 0 to 10, with 0 corresponding to no fatigue and 10 an extreme fatigue)",{"measure":43,"description":44,"timeFrame":17},"Cost-effectiveness of the ACCESS+ strategy","Total cost of the two strategies over the trial period and over the long term, in terms of disability adjusted life years, and quality-adjusted life years",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"RANDOMIZED","PARALLEL","two-arm, cluster-randomized, controlled phase 4 trial will be conducted in blood banks and HIV clinics (the clusters) in the two largest cities in Cameroon (Yaoundé and Douala).","TREATMENT",{"masking":52,"maskingDescription":45,"whoMasked":45},"NONE","A two-arm, cluster-randomized, controlled trial will be conducted in blood banks and HIV clinics (the clusters) in the two largest cities in Cameroon (Yaoundé and Douala).\n\nPersons aged 21 years or older, anti-HCV positive, and living in the study area will be eligible. The ACCESS+ strategy will rely on four components: (1) same-day on-site rapid anti-HCV and HCV RNA testing, (2) same-day on-site pan-genotypic DAA treatment initiation, (3) minimal clinical and biological monitoring, and (4) management by trained general medical doctors and counselors (community health workers, nurses or social workers) in non-specialist services. In contrast, in the standard strategy, the process for screening and treatment initiation will take longer, and anti-HCV positive participants will be managed by gastroenterologists and will have a closer follow-up.\n\nBiological and clinical data (using standardized case report forms), socioeconomic data (using standardized questionnaires), and qualitative data (using interviews and focus groups) will be collected. A total of 576 anti-HCV positive participants (288 per arm) will be recruited in 16 facilities (8 blood banks and 8 HIV clinics) after testing approximately 32,000 blood donors and 8,400 patients living with HIV. The total duration of the trial will be 36 months.",[55,62],{"label":56,"type":57,"description":58,"interventionNames":59},"ACCESS+ Strategy","EXPERIMENTAL","ACCESS+ strategy will rely on four components:\n\n1. same-day on-site rapid anti-HCV and HCV RNA testing,\n2. same-day on-site pan-genotypic DAA treatment initiation,\n3. minimal clinical and biological monitoring, and\n4. management by trained general medical doctors and counselors (community health workers, nurses or social workers) in non-specialist services.",[60,61],"Drug: ACCESS+ strategy Epclusa 400\u002F100 Oral Tablet","Drug: ACCESS+ Strategy Vosevi 400\u002F100\u002F100 Oral Tablet",{"label":63,"type":57,"description":64,"interventionNames":65},"Standard Strategy","In the standard strategy based on routine medical practice in Cameroon, anti-HCV positive participants will be referred to and managed by gastroenterologists, and the patients' management will be closer. However, the process for screening and treatment initiation will be longer.",[66,67],"Drug: Standard Strategy Vosevi 400\u002F100\u002F100 Oral Tablet","Drug: Standard Strategy Epclusa 400\u002F100 Oral Tablet",[69,74,78,82],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":45},"DRUG","ACCESS+ strategy Epclusa 400\u002F100 Oral Tablet","The ACCESS+ strategy will rely on four components: (1) same-day on-site rapid anti-HCV and HCV RNA testing (rapid diagnostic test and GeneXpert), (2) same-day on-site pan-genotypic DAA treatment initiation (sofosbuvir 400 mg\u002Fvelpatasvir 100 mg once daily for 12 weeks), (3) minimal clinical and biological monitoring, and (4) management of patients in non-specialist services by trained general medical doctors and counselors (community health workers, nurses or social workers).",[56],{"type":70,"name":75,"description":76,"armGroupLabels":77,"otherNames":45},"ACCESS+ Strategy Vosevi 400\u002F100\u002F100 Oral Tablet","The ACCESS+ strategy will rely on four components: (1) same-day on-site rapid anti-HCV and HCV RNA testing (rapid diagnostic test and GeneXpert), (2) same-day on-site pan-genotypic DAA treatment initiation (sofosbuvir 400 mg\u002Fvelpatasvir 100 mg\u002Fvoxilaprevir 100mg) once daily for 12 weeks, (3) minimal clinical and biological monitoring, and (4) management of patients in non-specialist services by trained general medical doctors and counselors (community health workers, nurses or social workers).",[56],{"type":70,"name":79,"description":80,"armGroupLabels":81,"otherNames":45},"Standard Strategy Vosevi 400\u002F100\u002F100 Oral Tablet","In the standard strategy based on routine medical practice in Cameroon, anti-HCV positive participants will be referred to and managed by gastroenterologists who will initiate pan-genotypic DAA treatment initiation (sofosbuvir 400 mg\u002Fvelpatasvir 100 mg\u002Fvoxilaprevir 100mg) once daily for 12 weeks, and the patients' management will be closer. However, the process for screening and treatment initiation will be longer.",[63],{"type":70,"name":83,"description":84,"armGroupLabels":85,"otherNames":45},"Standard Strategy Epclusa 400\u002F100 Oral Tablet","In the standard strategy based on routine medical practice in Cameroon, anti-HCV positive participants will be referred to and managed by gastroenterologists who will initiate pan-genotypic DAA treatment initiation (sofosbuvir 400 mg\u002Fvelpatasvir 100 mg) once daily for 12 weeks, and the patients' management will be closer. However, the process for screening and treatment initiation will be longer.",[63],[87,92],{"name":88,"role":89,"phone":90,"phoneExt":45,"email":91},"Christian LAURENT","CONTACT","+33 (0)4 67 41 61 50","christian.laurent@ird.fr",{"name":93,"role":89,"phone":45,"phoneExt":45,"email":94},"Tounes SAIDI","tounes.saidi@inserm.fr",{"type":96,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[98,101,103,105,107,109],{"name":99,"class":100},"IRD, Epidemiologie et Prevention, Montpelier, France","UNKNOWN",{"name":102,"class":100},"SESSTIM (IRD, Inserm, Université Aix-Marseille)",{"name":104,"class":100},"Centre de Recherche sur les Maladies Emergentes et Re-Emergentes (CREMER)",{"name":106,"class":100},"Faculté de Médecine et des Sciences Biomédicales, Université de Yaoundé I, Yaoundé, Cameroun",{"name":108,"class":100},"PharmAccess",{"name":110,"class":100},"Service d'hépato-gastroentérologie, Hôpital Saint Joseph, Marseille, France","100600514",false,"NCT07098481","Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy","ACCESS+","Inclusion Criteria:\n\n* Persons of both genders aged 21 years or older\n* Anti-HCV positive;\n* Living in the study area\n* Agreeing to participate in the trial and signing the informed consent form.\n\nExclusion Criteria:\n\n* Participationin a previous study on HCV treatment\n* Previous sofosbuvir treatment\n* HBsAg positive or indeterminate;\n* Pregnancy test positive ;\n* Life-threatening condition ;\n* Impairment of the person making it difficult, if not impossible, for them to participate in the trial or to understand the information given to them.","ALL","21 Years",{"count":120,"type":121},576,"ESTIMATED","INTERVENTIONAL",[124],"PHASE4","Hepatitis C is a common and potentially serious disease. However, there are treatments that can cure it. That's why it's so important to detect the hepatitis C virus (HCV) and treat those affected. Today, many hepatitis C sufferers in Cameroon (and elsewhere) remain untreated.\n\nThe aim of this research is therefore to evaluate a simplified screening and treatment strategy (developed specifically for the Cameroonian context) in comparison with a standard strategy (based on usual care), in order to improve access to hepatitis C treatment in Cameroon. If the results of this research are positive, this strategy could be recommended to health authorities in Cameroon and other comparable countries.",[127],"Hepatitis C Virus Infection",[129,130],"simplified test and treat strategy","hepatitis C","NOT_YET_RECRUITING","2025-07-31",{"date":134,"type":135},"2025-08-01","ACTUAL",{"date":137,"type":121},"2025-09-01",{"date":139,"type":121},"2028-06-30",{"name":5,"class":6}]