Hepatitis C Virus Infection
Conditions
Keywords
simplified test and treat strategy, hepatitis C
Brief summary
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.
Detailed description
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.
Interventions
DRUGACCESS+ strategy Epclusa 400/100 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/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).
DRUGACCESS+ Strategy Vosevi 400/100/100 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/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).
DRUGStandard Strategy Vosevi 400/100/100 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/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.
DRUGStandard Strategy Epclusa 400/100 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/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.
Sponsors
IRD, Epidemiologie et Prevention, Montpelier, France
SESSTIM (IRD, Inserm, Université Aix-Marseille)
Centre de Recherche sur les Maladies Emergentes et Re-Emergentes (CREMER)
Faculté de Médecine et des Sciences Biomédicales, Université de Yaoundé I, Yaoundé, Cameroun
PharmAccess
Service d'hépato-gastroentérologie, Hôpital Saint Joseph, Marseille, France
ANRS, Emerging Infectious Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persons of both genders aged 21 years or older * Anti-HCV positive; * Living in the study area * Agreeing to participate in the trial and signing the informed consent form.
Exclusion criteria
* Participationin a previous study on HCV treatment * Previous sofosbuvir treatment * HBsAg positive or indeterminate; * Pregnancy test positive ; * Life-threatening condition ; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of ACCESS+ strategy | 12 weeks after the end of treatment | % 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' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCV Cascade (HCV RNA positive) of care between both strategies | 12 weeks after end of treatment | % of anti-HCV positive patients who were HCV RNA positive |
| HCV Cascade (communication of HCV RNA Status) of care between the two strategies | 12 weeks after end of treatment | % of anti-HCV positive patients who were aware of HCV RNA status |
| HCV Cascade (start of treatment) of care between the two strategies | 12 weeks after end of treatment | % of HCV RNA positive patients who started direct-acting antiviral (DAA) treatment |
| HCV Cascade (treatment completed) of care between the two strategies | 12 weeks after the end of treatment | % of HCV RNA positive patients who completed the treatment; % of HCV RNA positive patients who were cured |
| HCV cascade (HCV RNA Test) of care between both strategies | 12 weeks after end of treatment | % of anti-HCV positive patients who had an HCV RNA test |
| Patient-reported outcomes between both strategies | 12 weeks after end of treatment | Barriers to HCV testing and treatment reported by patients and healthcare workers through qualitative interviews |
| Patient-reported outcomes (quality of life) between both strategies | 12 weeks after end of treatment | Changes in health-related quality of life in Short Form-12 scale (SF-12), giving a physical and mental health summary of the participant |
| Patient-reported outcomes (fatigue) between both strategies | 12 weeks after end of treatment | Changes in fatigue reported in Fatigue scale (scale graduated from 0 to 10, with 0 corresponding to no fatigue and 10 an extreme fatigue) |
| Cost-effectiveness of the ACCESS+ strategy | 12 weeks after end of treatment | 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 |
| HCV Cascade (patients cured) of care between the two strategies | 12 weeks after the end of treatment | % of HCV RNA positive patients who were cured |
Contacts
Primary ContactChristian LAURENT
Backup ContactTounes SAIDI
Outcome results
None listed