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

Hepatitis C Clinical Trial

— Cam-C  

Official title:

Community Versus Facility-based Services to Improve the Screening of Active HCV Infection in Cambodia: a Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03992313
• Other study ID #: ANRS 12384
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: June 2019
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: Sansothy Neth, MD
• Phone: 85561898668
• Email: nsothy[@]uhs.edu.kh
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4500
• Est. completion date: October 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• Testing

Intervention

Other:
• Community-based HCV rapid test
HCV rapid tests will be done in the village
• Facility-based HCV rapid test
HCV rapid tests will be done in the health center
• Plasmatic HCV viral load
HCV viral load will be done in provincial hospital on plasma using GenXpert
• DBS HCV viral load
HCV viral load will be done in Phnom Penh by DBS using Omunis kit

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Fondation Mérieux, Hopital Paul Brousse, Institut National de la Santé Et de la Recherche Médicale, France, University of Health Sciences, Phnom Penh, Cambodia, University of Marseille

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Liver-related morbidity and mortality	Proportion of patients with decompensated cirrhosis, HCC (measured for the total population and not compared)	18 months
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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