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NCT Number: NCT07098481

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

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Effectiveness of ACCESS+ strategy

    Time frame: 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 outcomes

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

    Time frame: 12 weeks after end of treatment

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

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

    Time frame: 12 weeks after end of treatment

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

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

    Time frame: 12 weeks after end of treatment

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

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

    Time frame: 12 weeks after end of treatment

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

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

    Time frame: 12 weeks after the end of treatment

    % of HCV RNA positive patients who completed the treatment; % of HCV RNA positive patients who were cured

  6. HCV Cascade (patients cured) of care between the two strategies

    Time frame: 12 weeks after the end of treatment

    % of HCV RNA positive patients who were cured

  7. Patient-reported outcomes between both strategies

    Time frame: 12 weeks after end of treatment

    Barriers to HCV testing and treatment reported by patients and healthcare workers through qualitative interviews

  8. Patient-reported outcomes (quality of life) between both strategies

    Time frame: 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

  9. Patient-reported outcomes (fatigue) between both strategies

    Time frame: 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)

  10. Cost-effectiveness of the ACCESS+ strategy

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Christian LAURENT

CONTACT

[email protected]

+33 (0)4 67 41 61 50

Tounes SAIDI

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

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

Registry information

Acronym: ACCESS+

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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