Hepatitis CCam-CNCT03992313
Community Versus Facility-based Services to Improve the Screening of Active HCV Infection in Cambodia
A study testing Community-based HCV rapid test, Facility-based HCV rapid test and Plasmatic HCV viral load in people with Hepatitis C and Testing, run by ANRS, Emerging Infectious Diseases at 2 sites in Cambodia.
Trial summary
Objectives Principal objective: to compare the effectiveness of a community-based intervention to a facility-based intervention to improve the combined-testing uptake (Antibody + RNA) of HCV infection among general population aged more than 40 years old in Cambodia Secondary objectives To compare the HCV antibody… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Testing
- What is being tested?
- Community-based HCV rapid test, Facility-based HCV rapid test and Plasmatic HCV viral load
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,692 participants
- Where
- 2 sitesCambodia
- Study dates
- 21 Apr 2022to 23 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All persons aged more than 40 years old
- Residing in the study area
- Informed consent obtained with oral information given and explained and the consent form signed by the participant and the nurse hired by the study at the latest the time of the RDT realization
Who cannot join
- Known positive HCV status with previous HCV treatment
- Severe disease present at inclusion involving life threatening
- Concurrent participation in any other clinical study without written agreement of the two study teams
Trial locations and contacts
2 sites in 1 country.
Cambodia2 sites
Chrey Vean Health Center
Kampong Cham, Kampong Cham
Han Chey Health Center
Kampong Cham, Kampong Cham
About this study
Official title: Community Versus Facility-based Services to Improve the Screening of Active HCV Infection in Cambodia: a Cluster Randomized Controlled Trial
Objectives Principal objective: to compare the effectiveness of a community-based intervention to a facility-based intervention to improve the combined-testing uptake (Antibody + RNA) of HCV infection among general population aged more than 40 years old in Cambodia Secondary objectives
- To compare the HCV antibody testing uptake between the 2 arms for the eligible population
- To compare the active case detection rate between the 2 arms for the eligible population
- To compare the linkage to care between the 2 arms for those with active infection
- To compare the cost-effectiveness of the two strategies
- To evaluate the treatment uptake
- To evaluate the effectiveness and safety of a 12-week dual-therapy of direct-acting antiviral (DAA) treatment
Read the detailed description
Methodology: two-arms cluster-randomized controlled trial. Clusters are defined as a group of 50 households
Expected enrolment : 8000 patients in 160 clusters, 80 villages in each of the 2 provinces (Kompong Cham and Siem Reap)
Intervention
Arm 1: Facility-based testing intervention A team of community Health Workers (CHWs) will prepare a schedule to visit the selected villages and provide mass information on the possibility to be tested in health centers for HCV infection. Information will be provided using information sheet and a dedicated leaflet. If the participant agrees to participate, the signed consent form will be collected at this step. HCV testing will be done in one of the referrals health centers. HCV screening will be done using the SD Bioline HCV RDT on a finger stick capillary whole blood. Results will be available in 15 minutes. In case of positive HCV RDT, an immediate blood sample collection will be done in health center and sent to Provincial Hospital to perform HCV RNA using GenXpert viral load assay on plasma. Results will be sent back to the health center and nurses will be in charge to give result to the participant and to refer to care in case of active infection
Arm 2: Community-based testing intervention After a dedicated training, CHWs will do the SD Bioline HCV RDT on a finger stick capillary whole blood directly in the household of participant. Information will be provided by the CHW using information sheet and a dedicated leaflet. If the participant agrees to participate, the signed consent form will be collected at this step before any RDT collection. In case of structural or societal barriers for household testing, it will be possible to provide testing in a specific location in the village. The onsite visits will be planned with the head of village who will be in charge to inform the population about the study. In case of absence of participant during the first visit, a second visit will be scheduled. In absence of participant during the second visit, no additional visit will be planned. In case of positive HCV RDT, 5 blood spots will be collected immediately on DBS, dried at ambient temperature and put in an individual plastic bag with the ID number and sent to Phnom Penh (Rodolphe Merieux laboratory) for HCV RNA extraction and amplification (Omunis). Results will be sent back to the referral health center and nurses will be in charge to give result to the participant and to refer to care in case of active infection.
Treatment phase For positive HCV RNA, a consultation in the Provincial Hospital will be planned. The Baseline assessment will include questionnaires (risk behaviours and socio-economic status), clinical exam, blood sampling and liver ultrasound. Symptomatic cirrhotic patients will be referred to a National Hospital in Phnom Penh to a hepatology department. For the others patients, DAA treatment using sofosbuvir and daclatasvir combination for 12 weeks (Cambodian Essential Medicine List 2018) will be proposed, after checking the result of creatinine and the possible drug-drug interactions.
- Conditions
- Hepatitis C, Testing
- Being tested
- Community-based HCV rapid test, Facility-based HCV rapid test, Plasmatic HCV viral load, DBS HCV viral load
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based HCV rapid testOther
HCV rapid tests will be done in the village
Facility-based HCV rapid testOther
HCV rapid tests will be done in the health center
Plasmatic HCV viral loadOther
HCV viral load will be done in provincial hospital on plasma using GenXpert
DBS HCV viral loadOther
HCV viral load will be done in Phnom Penh by DBS using Omunis kit
| Study group | Role | What they receive |
|---|---|---|
| Facility-based testing intervention | Experimental | * mass information on the possibility to be tested in health centers for HCV infection by CHWs ( information sheet and dedicated leaflet provided)
* signed consent form collected at this step
* HCV testing done in one of the referrals health centers, using the SD Bioline HCV RDT on a finger stick capillary whole blood.
* In case of positive HCV RDT, immediate blood sample collection done in health center and sent to Provincial Hospital to perform HCV RNA using GenXpert viral load assay on plasma.
* Results sent back to the health center and nurses in charge to give result to the participant and to refer to care in case of active infection Receives: Other: Facility-based HCV rapid test; Other: Plasmatic HCV viral load |
| Community-based testing intervention | Experimental | * dedicated training for CHWs to do the SD Bioline HCV RDT on a finger stick capillary whole blood directly in the household of participant.
* Information provided by the CHW (information sheet and a dedicated Leaflet)
* Signed consent form collected at this step.
* onsite visits planned with the head of village in charge to inform the population about the study
* In case of positive HCV RDT, 5 blood spots collected immediately on DBS and sent to Phnom Penh (Rodolphe Merieux laboratory) for HCV RNA extraction and amplification (Omunis)
* Results sent back to the referral health center and nurses in charge to give result to the participant and to refer to care in case of active infection Receives: Other: Community-based HCV rapid test; Other: DBS HCV viral load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined-testing uptake
Combined-testing uptake defined as the number of persons tested for HCV RDT AND HCV RNA and aware of their status among the total number of persons eligible residing in the region where the intervention takes place
Measured: 12 months
Secondary outcomes (3)
HCV antibody testing uptake
HCV antibody testing uptake defined as the number of persons tested for HCV RDT and aware of their status among the total number of persons eligible residing in the region where the intervention takes place
Measured: 12 months
Active case detection rate
defined as the number of persons with HCV active infection (positive HCV Ab and positive HCV RNA) and results given and explained among the total number of persons eligible residing in the region where the intervention takes place (measured and compared between the 2 arms)
Measured: 12 months
Linkage to care
the number of persons with at least one consultation in the Provincial Hospital among the estimated total number of persons with active infection residing in the region where the intervention takes place (measured and compared between the 2 arms)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start21 Apr 2022
- Primary completion23 Sep 2023
- Study completion23 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,692 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- University of Health Sciences, Phnom Penh, Cambodia, Hopital Paul Brousse, Institut National de la Santé Et de la Recherche Médicale, France, Fondation Mérieux, University of Marseille, SESSTIM UMR1252 (Aix-Marseille Univ, INSERM, IRD)
- Responsible party
- Sponsor
- Investigators
- Vonthanak Saphonn, PhD, Principal investigator, Saglik Bilimleri UniversitesiJean-Charles Duclos-Vallee, PhD, Principal investigator, Paul Brousse hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992313
- Sponsor's protocol ID
- ANRS 12384
- Acronym
- Cam-C
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2019
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khuon D, Sagaon-Teyssier L, Neth S, Saint S, Meyer L, Mosnier E, Molino D, Phoeung CL, Chhay C, Heang K, Mam S, Duclos-Vallee JC, Segeral O, Saphonn V. Community-based versus facility-based services to improve hepatitis C screening in Cambodia: a cluster randomized controlled trial (ANRS 12384 Cam-C study). Lancet Reg Health West Pac. 2025 Oct 8;63:101703. doi: 10.1016/j.lanwpc.2025.101703. eCollection 2025 Oct.
PubMed 41127705Mosnier E, Segeral O, Neth S, Sagaon-Teyssier L, Khuon D, Phoeung CL, Mam S, Chhay C, Heang K, Duclos-Vallee JC, Saphonn V. Community Versus Facility-Based Services to Improve the Screening of Active Hepatitis C Virus Infection in Cambodia: The ANRS 12384 CAM-C Cluster Randomized Controlled Trial-Protocol for a Mixed Methods Study. JMIR Res Protoc. 2024 Nov 20;13:e63376. doi: 10.2196/63376.
PubMed 39566053
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Versus Facility-based Services to Improve the Screening of Active HCV Infection in Cambodia: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03992313
- Acronym / sponsor ID
- Cam-C / ANRS 12384
- Conditions
- Hepatitis C, Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,692 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- University of Health Sciences, Phnom Penh, Cambodia, Hopital Paul Brousse, Institut National de la Santé Et de la Recherche Médicale, France, Fondation Mérieux, University of Marseille, SESSTIM UMR1252 (Aix-Marseille Univ, INSERM, IRD)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 23 Sep 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 20 Jun 2019 (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.
Objectives Principal objective: to compare the effectiveness of a community-based intervention to a facility-based intervention to improve the combined-testing uptake (Antibody + RNA) of HCV infection among general population aged more than 40 years old in Cambodia Secondary objectives
- To compare the HCV antibody testing uptake between the 2 arms for the eligible population
- To compare the active case detection rate between the 2 arms for the eligible population
- To compare the linkage to care between the 2 arms for those with active infection
- To compare the cost-effectiveness of the two strategies
- To evaluate the treatment uptake
- To evaluate the effectiveness and safety of a 12-week dual-therapy of direct-acting antiviral (DAA) treatment
Detailed description
Methodology: two-arms cluster-randomized controlled trial. Clusters are defined as a group of 50 households
Expected enrolment : 8000 patients in 160 clusters, 80 villages in each of the 2 provinces (Kompong Cham and Siem Reap)
Intervention
Arm 1: Facility-based testing intervention A team of community Health Workers (CHWs) will prepare a schedule to visit the selected villages and provide mass information on the possibility to be tested in health centers for HCV infection. Information will be provided using information sheet and a dedicated leaflet. If the participant agrees to participate, the signed consent form will be collected at this step. HCV testing will be done in one of the referrals health centers. HCV screening will be done using the SD Bioline HCV RDT on a finger stick capillary whole blood. Results will be available in 15 minutes. In case of positive HCV RDT, an immediate blood sample collection will be done in health center and sent to Provincial Hospital to perform HCV RNA using GenXpert viral load assay on plasma. Results will be sent back to the health center and nurses will be in charge to give result to the participant and to refer to care in case of active infection
Arm 2: Community-based testing intervention After a dedicated training, CHWs will do the SD Bioline HCV RDT on a finger stick capillary whole blood directly in the household of participant. Information will be provided by the CHW using information sheet and a dedicated leaflet. If the participant agrees to participate, the signed consent form will be collected at this step before any RDT collection. In case of structural or societal barriers for household testing, it will be possible to provide testing in a specific location in the village. The onsite visits will be planned with the head of village who will be in charge to inform the population about the study. In case of absence of participant during the first visit, a second visit will be scheduled. In absence of participant during the second visit, no additional visit will be planned. In case of positive HCV RDT, 5 blood spots will be collected immediately on DBS, dried at ambient temperature and put in an individual plastic bag with the ID number and sent to Phnom Penh (Rodolphe Merieux laboratory) for HCV RNA extraction and amplification (Omunis). Results will be sent back to the referral health center and nurses will be in charge to give result to the participant and to refer to care in case of active infection.
Treatment phase For positive HCV RNA, a consultation in the Provincial Hospital will be planned. The Baseline assessment will include questionnaires (risk behaviours and socio-economic status), clinical exam, blood sampling and liver ultrasound. Symptomatic cirrhotic patients will be referred to a National Hospital in Phnom Penh to a hepatology department. For the others patients, DAA treatment using sofosbuvir and daclatasvir combination for 12 weeks (Cambodian Essential Medicine List 2018) will be proposed, after checking the result of creatinine and the possible drug-drug interactions.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facility-based testing intervention | Experimental | Other: Facility-based HCV rapid test, Other: Plasmatic HCV viral load* mass information on the possibility to be tested in health centers for HCV infection by CHWs ( information sheet and dedicated leaflet provided) * signed consent form collected at this step * HCV testing done in one of the referrals health centers, using the SD Bioline HCV RDT on a finger stick capillary whole blood. * In case of positive HCV RDT, immediate blood sample collection done in health center and sent to Provincial Hospital to perform HCV RNA using GenXpert viral load assay on plasma. * Results sent back to the health center and nurses in charge to give result to the participant and to refer to care in case of active infection |
| Community-based testing intervention | Experimental | Other: Community-based HCV rapid test, Other: DBS HCV viral load* dedicated training for CHWs to do the SD Bioline HCV RDT on a finger stick capillary whole blood directly in the household of participant. * Information provided by the CHW (information sheet and a dedicated Leaflet) * Signed consent form collected at this step. * onsite visits planned with the head of village in charge to inform the population about the study * In case of positive HCV RDT, 5 blood spots collected immediately on DBS and sent to Phnom Penh (Rodolphe Merieux laboratory) for HCV RNA extraction and amplification (Omunis) * Results sent back to the referral health center and nurses in charge to give result to the participant and to refer to care in case of active infection |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All persons aged more than 40 years old
- Residing in the study area
- Informed consent obtained with oral information given and explained and the consent form signed by the participant and the nurse hired by the study at the latest the time of the RDT realization
Key exclusion criteria (3 listed)
- Known positive HCV status with previous HCV treatment
- Severe disease present at inclusion involving life threatening
- Concurrent participation in any other clinical study without written agreement of the two study teams
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 |
|---|---|---|
| Community-based HCV rapid testHCV rapid tests will be done in the village | Other | Community-based testing intervention |
| Facility-based HCV rapid testHCV rapid tests will be done in the health center | Other | Facility-based testing intervention |
| Plasmatic HCV viral loadHCV viral load will be done in provincial hospital on plasma using GenXpert | Other | Facility-based testing intervention |
| DBS HCV viral loadHCV viral load will be done in Phnom Penh by DBS using Omunis kit | Other | Community-based testing intervention |
Primary outcome
Combined-testing uptake
Time frame: 12 months
Combined-testing uptake defined as the number of persons tested for HCV RDT AND HCV RNA and aware of their status among the total number of persons eligible residing in the region where the intervention takes place
3 secondary outcomes
HCV antibody testing uptake
Time frame: 12 months
Active case detection rate
Time frame: 12 months
Linkage to care
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Derived from this study: PubMed 41127705Khuon D, Sagaon-Teyssier L, Neth S, Saint S, Meyer L, Mosnier E, Molino D, Phoeung CL, Chhay C, Heang K, Mam S, Duclos-Vallee JC, Segeral O, Saphonn V. Community-based versus facility-based services to improve hepatitis C screening in Cambodia: a cluster randomized controlled trial (ANRS 12384 Cam-C study). Lancet Reg Health West Pac. 2025 Oct 8;63:101703. doi: 10.1016/j.lanwpc.2025.101703. eCollection 2025 Oct.
- Derived from this study: PubMed 39566053Mosnier E, Segeral O, Neth S, Sagaon-Teyssier L, Khuon D, Phoeung CL, Mam S, Chhay C, Heang K, Duclos-Vallee JC, Saphonn V. Community Versus Facility-Based Services to Improve the Screening of Active Hepatitis C Virus Infection in Cambodia: The ANRS 12384 CAM-C Cluster Randomized Controlled Trial-Protocol for a Mixed Methods Study. JMIR Res Protoc. 2024 Nov 20;13:e63376. doi: 10.2196/63376.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Vonthanak Saphonn, PhD principal investigator
Saglik Bilimleri Universitesi
Jean-Charles Duclos-Vallee, PhD principal investigator
Paul Brousse hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based HCV rapid test, Facility-based HCV rapid test and Plasmatic HCV viral load in people with Hepatitis C and Testing, run by ANRS, Emerging Infectious Diseases at 2 sites in Cambodia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined-testing uptake (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03992313, which also lists 2 linked publications.
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 22 Jun 2025; AzTrials last refreshed its copy on 27 Oct 2026.