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

ANRS, Emerging Infectious Diseases

Status: Completed

Conditions: Testing; Hepatitis C

Treatments: Other: Facility-based HCV rapid test; Other: DBS HCV viral load; Other: Plasmatic HCV viral load; Other: Community-based HCV rapid test

Study type: Interventional

Funder types: Other

Identifiers

NCT03992313

ANRS 12384

Details and patient eligibility

About

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

Full 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.

Enrollment: 7,692 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,692 participants in 2 patient groups

Facility-based testing intervention

Experimental group

Description:

* 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

Treatment:

Other: Plasmatic HCV viral load

Other: Facility-based HCV rapid test

Community-based testing intervention

Experimental group

Description:

* 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

Treatment:

Other: Community-based HCV rapid test

Other: DBS HCV viral load