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Evaluation of Hepatitis C Viral Load Quantification on DBS in Vietnam (MOVIDA-Hep)

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ClinicalTrials.gov Identifier: NCT03670251
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : June 26, 2019
Sponsor:
Collaborators:
National Institute of Hygiene and Epidemiology - Vietnam (NIHE)
Hanoi University of Public Health (HUPH)
Information provided by (Responsible Party):
Institut Pasteur

Brief Summary:

In Vietnam, the prevalence of hepatitis C virus (HCV) infection is estimated between 0.4% and 5%, which is much higher than the prevalence in Europe or in the USA. After HCV diagnosis, HCV viral load quantification is crucial in order to distinguish recovered from active (on-going) HCV infection and hence identify those who need antiviral treatment to cure HCV infection. HCV viral load quantification is also important to assess treatment efficacy.

Currently, anti-HCV antibodies detection is available around the country. However, access to confirmation of HCV viremia remains scarce particularly in decentralized areas. One of the reason is the limited number of laboratories able to perform this complex biological measurement; moreover, these laboratories are situated only in large urban centres.

Blood sampling using DBS could help overcome this difficulty of access to a laboratory, and widen access to HCV viral load monitoring.

The present MOVIDA Hep study aims at validating the use of DBS to measure HCV viral load as compared to plasma (gold standard). A secondary objective is to evaluate the measurement of HCV core antigen on DBS. For this, 315 patients need to be enrolled form outpatient clinics in Hanoi. The laboratory in charge of these measurements would be the virology laboratory of the National Institute of Hygiene and Epidemiology (NIHE) in Hanoi (Vietnam).


Condition or disease Intervention/treatment Phase
Hepatitis C Dried Blood Spot Procedure: Blood sampling Not Applicable

Detailed Description:

The "Monitoring Of Viral load In Decentralised Area" (MOVIDA) project aims at giving access to viral load (VL) monitoring to the patients coming from remote areas using Dried Blood Spot as tool of sampling.

In resource-limited settings, many biological exams are not accessible to the entire population due to logistic and financial constraints. Regarding infection with hepatitis B and C viruses (HBV and HCV), serological screening tests are easy to perform and are available nationwide in either laboratory format or rapid diagnosis tests. However, hepatitis B DNA and C RNA assessment is not available in decentralised area as no laboratory is able to perform this complex biological measurement.

WHO, in their latest guidelines, recommends using dried blood spots (DBS) as an alternative to serum or plasma. Blood is easy to collect on DBS, either after veni- or capillary puncture. Capillary blood collection can be of great interest when venipuncture is complex, for example in injecting drug users (IDUs) in whom finding an accessible vein can be difficult. Then it is easily transferred, and at a low cost as it does not require a cold chain, to a laboratory able to perform the HCV VL quantification. As of today, little is known about the performance of standard commercial HCV diagnostic assays when using DBS and none of these studies were performed in routine setting in resource-limited setting.

In Vietnam, HCV seroprevalence in the general population is estimated between 0.4% and 5%, which is much higher than the prevalence in Europe or in the US. Genotype 1 is the more prevalent in Vietnam, genotype 6 that is only found in South East Asia is the second most frequent, but other genotypes are circulating . In Vietnam, HCV prevalence is much higher in the HIV-infected population and in injecting drug users (IDUs). Currently, anti-HCV antibodies detection is available around the country even if some difficulties remain. However, access to HCV HCV viral load measurement in routine remains scarce particularly in decentralized areas because the technique is complex, expensive and need well-trained personnel and high standard of equipment. Thus, HCV viral load measurement remains non accessible to the vast majority of patients diagnosed with HCV.

This study (MOVIDA Hep) aims at evaluating the quality of HCV VL monitoring when using DBS (collection of venous and capillary blood) as compared to plasma (gold standard), in routine condition and using the existing machines. This, to find out if DBS can be used for HCV viremia confirmation in Vietnam, in the virology laboratory of the National Institute of Hygiene and Epidemiology (NIHE) in Hanoi (Vietnam) where these measurements would be performed.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 315 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improving Access to Viral Load Monitoring in HIV-infected Patients on ART in Decentralised Area Using Dried Blood Spot : Evaluation of Hepatitis C Viral Load Quantification on DBS
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Blood sampling
blood samples from venepuncture (10mL) and from fingertip (approximatively 0.4mL) on a dried blood spots
Procedure: Blood sampling
Blood sample of 10 mL by venipuncture and 0,4 mL by finger prick




Primary Outcome Measures :
  1. Quantification of HCV RNA on DBS compared to plasma as gold standard [ Time Frame: Up to 4 weeks ]
    Sensitivity and specificity of HCV RNA VL measured on DBS collected by venipuncture


Secondary Outcome Measures :
  1. Quantification of HCV RNA measured on DBS using plasma as gold standard [ Time Frame: Up to 4 weeks ]
    Sensitivity and specificity of HCV RNA VL measured on DBS collected by finger prick

  2. Correlation between HCV RNA VL measured on DBS and on plasma. [ Time Frame: Up to 6 months ]
    Correlation between HCV RNA VL measured on DBS (collected by venipuncture and finger prick) and on plasma.

  3. Quantification of HCV core antigen using HCV RNA VL as gold standard [ Time Frame: Up to 8 weeks ]
    Sensitivity and specificity of HCV core antigen using HCV RNA VL as gold standard

  4. Correlation between HCV core antigen and HCV RNA VL on plasma [ Time Frame: Up to 6 months ]
    Correlation between HCV core antigen and HCV RNA VL, both measured on plasma.

  5. Quantification of HCV core antigen measured on DBS using HCV RNA VL measured on plasma as gold standard. [ Time Frame: Up to 8 weeks ]
    Sensitivity and specificity of HCV core antigen measured on DBS collected by venipuncture using HCV RNA VL measured on plasma as gold standard.

  6. Correlation between HCV core antigen measured on DBS and HCV RNA VL measured on plasma. [ Time Frame: Up to 6 months ]
    Correlation between HCV core antigen measured on DBS collected by venipuncture and HCV RNA VL measured on plasma.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years of age
  • Known HCV infection
  • Willing to participate to the study by giving his/her consent.

Exclusion Criteria:

None


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): NCT03670251


Contacts
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Contact: Fabien TAIEB, MD, PhD, MPH +33(0)140613456 fabien.taieb@pasteur.fr
Contact: Yoann MADEC, PhD +33(0)140613828 yoann.madec@pasteur.fr

Locations
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Vietnam
Dong Da Hospital Recruiting
Hanoi, Vietnam
Contact: Dong Thi Van Anh, MD         
Nam Tu Liem Hospital Recruiting
Hanoi, Vietnam
Contact: Mai Thi Bich Hong, MD         
Sponsors and Collaborators
Institut Pasteur
National Institute of Hygiene and Epidemiology - Vietnam (NIHE)
Hanoi University of Public Health (HUPH)
Investigators
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Principal Investigator: Fabien TAIEB, MD, PhD, MPH Institut Pasteur
Principal Investigator: Tuan Anh NGUYEN, MD, PhD National Institute of Hygiene and Epidemiology (NIHE)

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03670251     History of Changes
Other Study ID Numbers: 2017-076
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: June 26, 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
Keywords provided by Institut Pasteur:
HCV Viral Load, Dried Blood Spot, HCV Core Ag
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections