Evaluation of Hepatitis C Viral Load Quantification on DBS in Vietnam

NCT03670251 | Completed

• 1 other identifier: 2017-076
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 2

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).

Conditions

Hepatitis C; Dried Blood Spot

Keywords

HCV Viral Load, Dried Blood Spot, HCV Core Ag

Outcome Measures

Primary Outcomes (1)

• Quantification of HCV RNA on DBS compared to plasma as gold standard

  Sensitivity and specificity of HCV RNA VL measured on DBS collected by venipuncture

  Up to 4 weeks

Secondary Outcomes (6)

• Quantification of HCV RNA measured on DBS using plasma as gold standard

  Up to 4 weeks

• Correlation between HCV RNA VL measured on DBS and on plasma.

  Up to 6 months

• Quantification of HCV core antigen using HCV RNA VL as gold standard

  Up to 8 weeks

• Correlation between HCV core antigen and HCV RNA VL on plasma

  Up to 6 months

• Quantification of HCV core antigen measured on DBS using HCV RNA VL measured on plasma as gold standard.

  Up to 8 weeks

Study Arms (1)

Blood sampling

OTHER

blood samples from venepuncture (10mL) and from fingertip (approximatively 0.4mL) on a dried blood spots

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

Blood sample of 10 mL by venipuncture and 0,4 mL by finger prick

Blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Institut Pasteur: lead
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator
• Hanoi University of Public Health: collaborator

Study Sites (2)

Dong Da Hospital

Hanoi, Vietnam

Location

Nam Tu Liem Hospital

Hanoi, Vietnam

Location

Related Publications (4)

• Taieb F, Tran Hong T, Ho HT, Nguyen Thanh B, Pham Phuong T, Viet Ta D, Le Thi Hong N, Ba Pham H, Nguyen LTH, Nguyen HT, Nguyen TT, Tuaillon E, Delaporte E, Le Thi H, Tran Thi Bich H, Nguyen TA, Madec Y. First field evaluation of the optimized CE marked Abbott protocol for HIV RNA testing on dried blood spot in a routine clinical setting in Vietnam. PLoS One. 2018 Feb 9;13(2):e0191920. doi: 10.1371/journal.pone.0191920. eCollection 2018.

  PMID: 29425216 BACKGROUND

• Taieb F, Tram TH, Ho HT, Pham VA, Nguyen L, Pham BH, Tong LA, Tuaillon E, Delaporte E, Nguyen AT, Bui DD, Do N, Madec Y. Evaluation of Two Techniques for Viral Load Monitoring Using Dried Blood Spot in Routine Practice in Vietnam (French National Agency for AIDS and Hepatitis Research 12338). Open Forum Infect Dis. 2016 Jul 7;3(3):ofw142. doi: 10.1093/ofid/ofw142. eCollection 2016 Sep.

  PMID: 27704001 BACKGROUND

• Soulier A, Poiteau L, Rosa I, Hezode C, Roudot-Thoraval F, Pawlotsky JM, Chevaliez S. Dried Blood Spots: A Tool to Ensure Broad Access to Hepatitis C Screening, Diagnosis, and Treatment Monitoring. J Infect Dis. 2016 Apr 1;213(7):1087-95. doi: 10.1093/infdis/jiv423. Epub 2015 Sep 2.

  PMID: 26333945 BACKGROUND

• Tran TH, Nguyen BT, Nguyen TA, Pham TTP, Nguyen TTT, Mai HTB, Pham HB, Nguyen TM, Phan HTT, Do NT, Ait-Ahmed M, Taieb F, Madec Y. Dried blood spots perform well to identify patients with active HCV infection in Vietnam. J Viral Hepat. 2020 May;27(5):514-519. doi: 10.1111/jvh.13263. Epub 2020 Feb 11.

  PMID: 31981287 RESULT

Related Links

• WHO Guidelines on Hepatitis B and C Testing

MeSH Terms

Conditions

Hepatitis C

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Fabien TAIEB, MD, PhD, MPH

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

• Tuan Anh NGUYEN, MD, PhD

  National Institute of Hygiene and Epidemiology (NIHE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 13, 2018
• Study Start: May 9, 2019
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: April 1, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)