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

ConditionHepatitis C Virus Infection
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorANRS, Emerging Infectious Diseases

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participationin a previous study on HCV treatment

Previous sofosbuvir treatment

HBsAg positive or indeterminate;

Pregnancy test positive ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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.

Treatment groups

576 Participants
are divided into 2 treatment groups
Group A: ACCESS+ StrategyExperimental treatment 2 interventions
Group B: Standard StrategyExperimental treatment 2 interventions

Trial outcomes

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'

Time frame
12 weeks after the end of treatment

Secondary outcomes

1

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

% of anti-HCV positive patients who had an HCV RNA test

Time frame
12 weeks after end of treatment
2

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

% of anti-HCV positive patients who were HCV RNA positive

Time frame
12 weeks after end of treatment
3

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

Time frame
12 weeks after end of treatment
4

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

% of HCV RNA positive patients who started direct-acting antiviral (DAA) treatment

Time frame
12 weeks after end of treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ANRS, Emerging Infectious Diseases

Lead sponsor

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: