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Trial record 15 of 3477 for:    Facility

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

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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)

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

Condition or disease Intervention/treatment Phase
Hepatitis C Testing Other: Community-based HCV rapid test Other: Facility-based HCV rapid test Other: Plasmatic HCV viral load Other: DBS HCV viral load Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Community Versus Facility-based Services to Improve the Screening of Active HCV Infection in Cambodia: a Cluster Randomized Controlled Trial
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : October 31, 2020

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Other Outcome Measures:
  1. 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)

  2. Liver-related morbidity and mortality [ Time Frame: 18 months ]
    Proportion of patients with decompensated cirrhosis, HCC (measured for the total population and not compared)

  3. 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)

  4. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992313


Contacts
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Contact: Sansothy Neth, MD 85561898668 nsothy@uhs.edu.kh
Contact: Olivier Segeral, MD 85512479313 olivier_segeral@uhs.edu.kh

Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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
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Principal Investigator: Vonthanak Saphonn, PhD University of Health Sciences
Principal Investigator: Jean-Charles Duclos-Vallee, PhD Paul Brousse hospital

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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03992313     History of Changes
Other Study ID Numbers: ANRS 12384
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections