Community Versus Facility-based Services to Improve the Screening of Active HCV Infection in Cambodia (Cam-C)

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

Study Overview

• Status: Completed
• Conditions: Hepatitis C; Testing
• Intervention / Treatment: Other: Facility-based HCV rapid test; Other: Plasmatic HCV viral load; Other: Community-based HCV rapid test; Other: DBS HCV viral load

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 Type: Interventional
• Enrollment (Actual): 7692
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cambodia
  • Kampong Cham, Cambodia
    • Chrey Vean Health Center
  • Kampong Cham, Cambodia
    • Han Chey Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facility-based testing intervention; 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	Other: Facility-based HCV rapid test; HCV rapid tests will be done in the health center; Other: Plasmatic HCV viral load; HCV viral load will be done in provincial hospital on plasma using GenXpert
Experimental: Community-based testing intervention; 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	Other: Community-based HCV rapid test; HCV rapid tests will be done in the village; Other: DBS HCV viral load; HCV viral load will be done in Phnom Penh by DBS using Omunis kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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
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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Fondation Mérieux; University of Marseille; SESSTIM UMR1252 (Aix-Marseille Univ, INSERM, IRD); Hopital Paul Brousse; University of Health Sciences, Phnom Penh, Cambodia
• Investigators: Principal Investigator: Vonthanak Saphonn, PhD, Saglik Bilimleri Universitesi; Principal Investigator: Jean-Charles Duclos-Vallee, PhD, PAUL BROUSSE HOSPITAL

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Actual): September 23, 2023
• Study Completion (Actual): September 23, 2023

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis; Hepatitis C
• Other Study ID Numbers: ANRS 12384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No