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Trial record 15 of 3539 for:    Facility

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03992313
Recruitment Status : Not yet recruiting
First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborators:
University of Health Sciences, Phnom Penh, Cambodia
Hopital Paul Brousse
Institut National de la Santé Et de la Recherche Médicale, France
Fondation Mérieux
University of Marseille
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date June 20, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
Combined-testing uptake [ Time Frame: 12 months ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • HCV antibody testing uptake [ Time Frame: 12 months ]
    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)
  • Active case detection rate [ Time Frame: 12 months ]
    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)
  • Linkage to care [ Time Frame: 12 months ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 18, 2019)
  • Treatment uptake [ Time Frame: 18 months ]
    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)
  • Liver-related morbidity and mortality [ Time Frame: 18 months ]
    Proportion of patients with decompensated cirrhosis, HCC (measured for the total population and not compared)
  • Sustained virologic response 12 [ Time Frame: 18 months ]
    Proportion of patients with sustained virologic response 12 weeks after discontinuation of treatment (SVR12) (measured for the total population and not compared)
  • Treatment failure [ Time Frame: 18 months ]
    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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Community Versus Facility-based Services to Improve the Screening of Active HCV Infection in Cambodia
Official Title  ICMJE Community Versus Facility-based Services to Improve the Screening of Active HCV Infection in Cambodia: a Cluster Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Hepatitis C
  • Testing
Intervention  ICMJE
  • Other: Community-based HCV rapid test
    HCV rapid tests will be done in the village
  • 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
  • Other: DBS HCV viral load
    HCV viral load will be done in Phnom Penh by DBS using Omunis kit
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Facility-based HCV rapid test
    • Other: Plasmatic HCV viral load
  • 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.
    Interventions:
    • Other: Community-based HCV rapid test
    • Other: DBS HCV viral load
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
4500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sansothy Neth, MD 85561898668 nsothy@uhs.edu.kh
Contact: Olivier Segeral, MD 85512479313 olivier_segeral@uhs.edu.kh
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03992313
Other Study ID Numbers  ICMJE ANRS 12384
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor  ICMJE French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators  ICMJE
  • University of Health Sciences, Phnom Penh, Cambodia
  • Hopital Paul Brousse
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Fondation Mérieux
  • University of Marseille
Investigators  ICMJE
Principal Investigator: Vonthanak Saphonn, PhD Saglik Bilimleri Universitesi
Principal Investigator: Jean-Charles Duclos-Vallee, PhD Paul Brousse hospital
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP