Hepatitis C Virus InfectionPhase 4ACCESS+NCT07098481
Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy
A Phase 4 study testing ACCESS+ strategy Epclusa 400/100 Oral Tablet, ACCESS+ Strategy Vosevi 400/100/100 Oral Tablet and Standard Strategy Vosevi 400/100/100 Oral Tablet in people with Hepatitis C Virus Infection, run by ANRS, Emerging Infectious Diseases.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- ACCESS+ strategy Epclusa 400/100 Oral Tablet, ACCESS+ Strategy Vosevi 400/100/100 Oral Tablet and Standard Strategy Vosevi 400/100/100 Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tounes SAIDI contact
About this study
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.
Read the detailed 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.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- ACCESS+ strategy Epclusa 400/100 Oral Tablet, ACCESS+ Strategy Vosevi 400/100/100 Oral Tablet, Standard Strategy Vosevi 400/100/100 Oral Tablet, Standard Strategy Epclusa 400/100 Oral Tablet
- Keywords
- simplified test and treat strategy, hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACCESS+ strategy Epclusa 400/100 Oral TabletDrug
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 TabletDrug
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 TabletDrug
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 TabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard Strategy Vosevi 400/100/100 Oral Tablet; Drug: Standard Strategy Epclusa 400/100 Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 12 weeks after the end of treatment
Secondary outcomes (10)
HCV cascade (HCV RNA Test) of care between both strategies
% of anti-HCV positive patients who had an HCV RNA test
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 12 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- IRD, Epidemiologie et Prevention, Montpelier, France, SESSTIM (IRD, Inserm, Université Aix-Marseille), Centre de Recherche sur les Maladies Emergentes et Re-Emergentes (CREMER), Faculté de Médecine et des Sciences Biomédicales, Université de Yaoundé I, Yaoundé, Cameroun, PharmAccess, Service d'hépato-gastroentérologie, Hôpital Saint Joseph, Marseille, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098481
- Sponsor's protocol ID
- ANRS 0388s ACCESS+
- Acronym
- ACCESS+
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy
- ClinicalTrials.gov ID
- NCT07098481
- Acronym / sponsor ID
- ACCESS+ / ANRS 0388s ACCESS+
- Conditions
- Hepatitis C Virus Infection
- Keywords
- simplified test and treat strategy, hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- IRD, Epidemiologie et Prevention, Montpelier, France, SESSTIM (IRD, Inserm, Université Aix-Marseille), Centre de Recherche sur les Maladies Emergentes et Re-Emergentes (CREMER), Faculté de Médecine et des Sciences Biomédicales, Université de Yaoundé I, Yaoundé, Cameroun, PharmAccess, Service d'hépato-gastroentérologie, Hôpital Saint Joseph, Marseille, France
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| ACCESS+ Strategy | Experimental | Drug: ACCESS+ strategy Epclusa 400/100 Oral Tablet, Drug: ACCESS+ Strategy Vosevi 400/100/100 Oral TabletACCESS+ 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. |
| Standard Strategy | Experimental | Drug: Standard Strategy Vosevi 400/100/100 Oral Tablet, Drug: Standard Strategy Epclusa 400/100 Oral TabletIn 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Participationin a previous study on HCV treatment
- Previous sofosbuvir treatment
- HBsAg positive or indeterminate;
- Pregnancy test positive ;
- Life-threatening condition ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACCESS+ strategy Epclusa 400/100 Oral TabletThe 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). | Drug | ACCESS+ Strategy |
| ACCESS+ Strategy Vosevi 400/100/100 Oral TabletThe 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). | Drug | ACCESS+ Strategy |
| Standard Strategy Vosevi 400/100/100 Oral TabletIn 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. | Drug | Standard Strategy |
| Standard Strategy Epclusa 400/100 Oral TabletIn 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. | Drug | Standard Strategy |
Primary outcome
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'
10 secondary outcomes
HCV cascade (HCV RNA Test) of care between both strategies
Time frame: 12 weeks after end of treatment
HCV Cascade (HCV RNA positive) of care between both strategies
Time frame: 12 weeks after end of treatment
HCV Cascade (communication of HCV RNA Status) of care between the two strategies
Time frame: 12 weeks after end of treatment
HCV Cascade (start of treatment) of care between the two strategies
Time frame: 12 weeks after end of treatment
HCV Cascade (treatment completed) of care between the two strategies
Time frame: 12 weeks after the end of treatment
HCV Cascade (patients cured) of care between the two strategies
Time frame: 12 weeks after the end of treatment
Patient-reported outcomes between both strategies
Time frame: 12 weeks after end of treatment
Patient-reported outcomes (quality of life) between both strategies
Time frame: 12 weeks after end of treatment
Patient-reported outcomes (fatigue) between both strategies
Time frame: 12 weeks after end of treatment
Cost-effectiveness of the ACCESS+ strategy
Time frame: 12 weeks after end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tounes SAIDI contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACCESS+ strategy Epclusa 400/100 Oral Tablet, ACCESS+ Strategy Vosevi 400/100/100 Oral Tablet and Standard Strategy Vosevi 400/100/100 Oral Tablet in people with Hepatitis C Virus Infection, run by ANRS, Emerging Infectious Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian LAURENT (+33 (0)4 67 41 61 50, christian.laurent@ird.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of ACCESS+ strategy (time frame: 12 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.