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| Name | Class |
|---|---|
| IRD, Epidemiologie et Prevention, Montpelier, France | UNKNOWN |
| SESSTIM (IRD, Inserm, Université Aix-Marseille) | UNKNOWN |
| Centre de Recherche sur les Maladies Emergentes et Re-Emergentes (CREMER) | UNKNOWN |
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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.
The 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.
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).
Persons 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.
Biological 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACCESS+ Strategy | Experimental | ACCESS+ strategy will rely on four components:
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| Standard Strategy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACCESS+ strategy Epclusa 400/100 Oral Tablet | Drug | 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/velpatasvir 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| HCV Cascade (HCV RNA positive) of care between both strategies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian LAURENT | Contact | +33 (0)4 67 41 61 50 | christian.laurent@ird.fr | |
| Tounes SAIDI | Contact | tounes.saidi@inserm.fr |
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| Faculté de Médecine et des Sciences Biomédicales, Université de Yaoundé I, Yaoundé, Cameroun | UNKNOWN |
| PharmAccess | UNKNOWN |
| Service d'hépato-gastroentérologie, Hôpital Saint Joseph, Marseille, France | UNKNOWN |
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).
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| ACCESS+ Strategy Vosevi 400/100/100 Oral Tablet | Drug | 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/velpatasvir 100 mg/voxilaprevir 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). |
|
| Standard Strategy Vosevi 400/100/100 Oral Tablet | Drug | 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/velpatasvir 100 mg/voxilaprevir 100mg) once daily for 12 weeks, and the patients' management will be closer. However, the process for screening and treatment initiation will be longer. |
|
| Standard Strategy Epclusa 400/100 Oral Tablet | Drug | 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/velpatasvir 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. |
|
% of anti-HCV positive patients who were HCV RNA positive
| 12 weeks after end of treatment |
| 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 | 12 weeks after end of treatment |
| HCV Cascade (start of treatment) of care between the two strategies | % of HCV RNA positive patients who started direct-acting antiviral (DAA) treatment | 12 weeks after end of treatment |
| 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 | 12 weeks after the end of treatment |
| HCV Cascade (patients cured) of care between the two strategies | % of HCV RNA positive patients who were cured | 12 weeks after the end of treatment |
| Patient-reported outcomes between both strategies | Barriers to HCV testing and treatment reported by patients and healthcare workers through qualitative interviews | 12 weeks after end of treatment |
| 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 | 12 weeks after end of treatment |
| 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) | 12 weeks after end of treatment |
| 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 | 12 weeks after end of treatment |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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