A Phase 4 interventional study of ACCESS+ strategy Epclusa 400/100 Oral Tablet and ACCESS+ Strategy Vosevi 400/100/100 Oral Tablet in Hepatitis C Virus Infection, sponsored by ANRS, Emerging Infectious Diseases. Not yet recruiting. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 4, Interventional, and Treatment
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.
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.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's planned enrollment of 576 is above the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
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
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
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).
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).
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.
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.
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
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
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
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
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
HCV Cascade (treatment completed) of care between the two strategies
% of HCV RNA positive patients who completed the treatment; % of HCV RNA positive patients who were cured
Time frame: 12 weeks after the end of treatment
HCV Cascade (patients cured) of care between the two strategies
% of HCV RNA positive patients who were cured
Time frame: 12 weeks after the end of treatment
Patient-reported outcomes between both strategies
Barriers to HCV testing and treatment reported by patients and healthcare workers through qualitative interviews
Time frame: 12 weeks after end of treatment
Patient-reported outcomes (quality of life) between both strategies
Changes in health-related quality of life in Short Form-12 scale (SF-12), giving a physical and mental health summary of the participant
Time frame: 12 weeks after end of treatment
Patient-reported outcomes (fatigue) between both strategies
Changes in fatigue reported in Fatigue scale (scale graduated from 0 to 10, with 0 corresponding to no fatigue and 10 an extreme fatigue)
Time frame: 12 weeks after end of treatment
Cost-effectiveness of the ACCESS+ strategy
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
Time frame: 12 weeks after end of treatment
No study locations are listed for this record.
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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ANRS, Emerging Infectious Diseases