NCT03992313

Brief 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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,692

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
2.8 years until next milestone

Study Start

First participant enrolled

April 21, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2023

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

June 18, 2019

Last Update Submit

June 17, 2025

Conditions

Hepatitis CTesting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • HCV antibody testing uptake

    12 months

  • Active case detection rate

    12 months

  • Linkage to care

    12 months

Other Outcomes (4)

  • Treatment uptake

    18 months

  • Liver-related morbidity and mortality

    18 months

  • Sustained virologic response 12

    18 months

  • +1 more other outcomes

Study Arms (2)

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

Other: Facility-based HCV rapid testOther: 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

Other: Community-based HCV rapid testOther: DBS HCV viral load

Interventions

Community-based HCV rapid testOTHER

HCV rapid tests will be done in the village

Community-based testing intervention
Facility-based HCV rapid testOTHER

HCV rapid tests will be done in the health center

Facility-based testing intervention
Plasmatic HCV viral loadOTHER

HCV viral load will be done in provincial hospital on plasma using GenXpert

Facility-based testing intervention
DBS HCV viral loadOTHER

HCV viral load will be done in Phnom Penh by DBS using Omunis kit

Community-based testing intervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known positive HCV status with previous HCV treatment
  • Concurrent participation in any other clinical study without written agreement of the two study teams

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chrey Vean Health Center

Kampong Cham, Kampong Cham, Cambodia

Location

Han Chey Health Center

Kampong Cham, Kampong Cham, Cambodia

Location

Related Publications (2)

  • 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.

    PMID: 41127705DERIVED

  • 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.

    PMID: 39566053DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Vonthanak Saphonn, PhD

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

  • Jean-Charles Duclos-Vallee, PhD

    Paul Brousse hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 20, 2019

Study Start

April 21, 2022

Primary Completion

September 23, 2023

Study Completion

September 23, 2023

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)