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

The Principal objective is 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

Study Overview

• Status: Unknown
• 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 : 4500 patients in 80 clusters located in 2 provinces (Kompong Cham and Siem Reap)

Intervention

Arm 1: Facility-based testing intervention Community Health Workers (CHWs) will provide information inside their groups on the possibility to be tested in health centers for HCV infection. 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 that 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 village of participants. In case of positive HCV RDT, 5 blood spots will be collected immediately on DBS and sent to Phnom Penh for HCV RNA extraction and amplification (Omunis). Results will be sent back to the referral health center of each cluster and CHWs 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 rapid consultation 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 in a hepatology unit. For the others patients, DAA treatment using sofosbuvir and daclatasvir combination for 12 weeks will be proposed, after checking the result of creatinine and the possible drug-drug interactions. All adverse events will be assessed by the investigator and documented regardless of the possible causality with the concomitant treatments.

• Study Type: Interventional
• Enrollment (Anticipated): 4500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sansothy Neth, MD; Phone Number: 85561898668; Email: nsothy@uhs.edu.kh
• Study Contact Backup: Name: Olivier Segeral, MD; Phone Number: 85512479313; Email: olivier_segeral@uhs.edu.kh

Participation Criteria

Eligibility Criteria

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

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; Community Health Workers (CHWs) will provide information inside their groups on the possibility to be tested in health centers for HCV infection. 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 that will be 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; After a dedicated training, CHWs will do the SD Bioline HCV RDT on a finger stick capillary whole blood directly in the village of participants. In case of positive HCV RDT, 5 blood spots will be collected immediately on DBS and sent to Phnom Penh for HCV RNA extraction and amplification (Omunis). Results will be sent back to the referral health center of each cluster and CHWs will be 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	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 and compared between the 2 arms)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV antibody testing uptake	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 and compared between the 2 arms)	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)	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

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; 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 (Anticipated): August 1, 2019
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): October 31, 2020

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 20, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; 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