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

ANRS, Emerging Infectious Diseases

Status and phase: Not yet enrolling; Phase 4

Conditions: Hepatitis C Virus Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07098481

ANRS 0388s ACCESS+

Details and patient eligibility

About

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.

Full 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.

Enrollment: 576 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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576 participants in 2 patient groups

ACCESS+ Strategy

Experimental group

Description:

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.

Treatment:

Drug: ACCESS+ Strategy Vosevi 400/100/100 Oral Tablet

Drug: ACCESS+ strategy Epclusa 400/100 Oral Tablet

Standard Strategy

Experimental group

Description:

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.

Treatment:

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

Drug: Standard Strategy Epclusa 400/100 Oral Tablet