Clinical trial NCT03992313: Community Versus Facility-based Services to Improve the Screening of Active HCV Infection in Cambodia
Official title: Community Versus Facility-based Services to Improve the Screening of Active HCV Infection in Cambodia: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C
Testing
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: University of Health Sciences, Phnom Penh, Cambodia
name: Hopital Paul Brousse
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Fondation Mérieux
name: University of Marseille
First posted: 2019-06-20
Enrollment: 4500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Combined-testing uptake
timeFrame: 12 months
Secondary outcomes:
measure: HCV antibody testing uptake
timeFrame: 12 months
measure: Active case detection rate
timeFrame: 12 months
measure: Linkage to care
timeFrame: 12 months
Other outcomes:
measure: Treatment uptake
timeFrame: 18 months
measure: Liver-related morbidity and mortality
timeFrame: 18 months
measure: Sustained virologic response 12
timeFrame: 18 months
measure: Treatment failure
timeFrame: 18 months
Locations:
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Vonthanak Saphonn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Paul Brousse hospital
name: Jean-Charles Duclos-Vallee, PhD
role: PRINCIPAL_INVESTIGATOR
References: