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| Name | Class |
|---|---|
| University of Health Sciences, Phnom Penh, Cambodia | UNKNOWN |
| Hopital Paul Brousse | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facility-based testing intervention | Experimental |
|
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| Community-based testing intervention | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-based HCV rapid test | Other | HCV rapid tests will be done in the village |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Active case detection rate |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment uptake | the number of people initiating HCV treatment among the total number of persons with active infection linked to care (measured for the total population and not compared) | 18 months |
| Liver-related morbidity and mortality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vonthanak Saphonn, PhD | Saglik Bilimleri Universitesi | Principal Investigator |
| Jean-Charles Duclos-Vallee, PhD | Paul Brousse hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chrey Vean Health Center | Kampong Cham | Kampong Cham | Cambodia | |||
| Han Chey Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41127705 | Derived | 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. | |
| 39566053 |
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| Fondation Mérieux |
| OTHER |
| University of Marseille | OTHER |
| SESSTIM UMR1252 (Aix-Marseille Univ, INSERM, IRD) | UNKNOWN |
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| Facility-based HCV rapid test | Other | HCV rapid tests will be done in the health center |
|
| Plasmatic HCV viral load | Other | HCV viral load will be done in provincial hospital on plasma using GenXpert |
|
| DBS HCV viral load | Other | HCV viral load will be done in Phnom Penh by DBS using Omunis kit |
|
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) |
| 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) | 12 months |
Proportion of patients with decompensated cirrhosis, HCC (measured for the total population and not compared)
| 18 months |
| Sustained virologic response 12 | Proportion of patients with sustained virologic response 12 weeks after discontinuation of treatment (SVR12) (measured for the total population and not compared) | 18 months |
| Treatment failure | Proportion of patients with treatment failure defined as absence of SVR12 or missing HCV-RNA at 12 weeks post-treatment (PT12) due to treatment discontinuation for AEs or death (measured for the total population and not compared) | 18 months |
| Kampong Cham |
| Kampong Cham |
| Cambodia |
| Derived |
| Mosnier 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. |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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