Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy

Overview

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

• Drug ACCESS+ 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).
• Drug ACCESS+ 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).
• Drug Standard 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.
• Drug Standard 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.

Primary outcome measures

• Effectiveness of ACCESS+ strategy [Time frame: 12 weeks after the end of treatment]

Secondary outcome measures (10)

• HCV cascade (HCV RNA Test) of care between both strategies [Time frame: 12 weeks after end of treatment]
• HCV Cascade (HCV RNA positive) of care between both strategies [Time frame: 12 weeks after end of treatment]
• HCV Cascade (communication of HCV RNA Status) of care between the two strategies [Time frame: 12 weeks after end of treatment]
• HCV Cascade (start of treatment) of care between the two strategies [Time frame: 12 weeks after end of treatment]
• HCV Cascade (treatment completed) of care between the two strategies [Time frame: 12 weeks after the end of treatment]
• HCV Cascade (patients cured) of care between the two strategies [Time frame: 12 weeks after the end of treatment]
• Patient-reported outcomes between both strategies [Time frame: 12 weeks after end of treatment]
• Patient-reported outcomes (quality of life) between both strategies [Time frame: 12 weeks after end of treatment]
• Patient-reported outcomes (fatigue) between both strategies [Time frame: 12 weeks after end of treatment]
• Cost-effectiveness of the ACCESS+ strategy [Time frame: 12 weeks after end of treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07098481 · ANRS 0388s ACCESS+

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗