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

NCT07098481 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: ANRS 0388s ACCESS+
• Study Type: interventional
• Target: 576
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C Virus Infection

Keywords

simplified test and treat strategy; hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• HCV cascade (HCV RNA Test) of care between both strategies

  12 weeks after end of treatment

• HCV Cascade (HCV RNA positive) of care between both strategies

  12 weeks after end of treatment

• HCV Cascade (communication of HCV RNA Status) of care between the two strategies

  12 weeks after end of treatment

• HCV Cascade (start of treatment) of care between the two strategies

  12 weeks after end of treatment

• HCV Cascade (treatment completed) of care between the two strategies

  12 weeks after the end of treatment

Study Arms (2)

ACCESS+ Strategy

EXPERIMENTAL

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.

Drug: ACCESS+ strategy Epclusa 400/100 Oral Tablet; Drug: ACCESS+ Strategy Vosevi 400/100/100 Oral Tablet

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.

Drug: Standard Strategy Vosevi 400/100/100 Oral Tablet; Drug: Standard Strategy Epclusa 400/100 Oral Tablet

Interventions

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).

ACCESS+ Strategy

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).

ACCESS+ Strategy

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

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.

Standard Strategy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• IRD, Epidemiologie et Prevention, Montpelier, France: collaborator
• SESSTIM (IRD, Inserm, Université Aix-Marseille): collaborator
• Centre de Recherche sur les Maladies Emergentes et Re-Emergentes (CREMER): collaborator
• Faculté de Médecine et des Sciences Biomédicales, Université de Yaoundé I, Yaoundé, Cameroun: collaborator
• PharmAccess: collaborator
• Service d'hépato-gastroentérologie, Hôpital Saint Joseph, Marseille, France: collaborator

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Christian LAURENT

CONTACT

+33 (0)4 67 41 61 50; christian.laurent@ird.fr

Tounes SAIDI

CONTACT

tounes.saidi@inserm.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: August 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07