Hepatitis CMOVIDA-HepNCT03670251
Evaluation of Hepatitis C Viral Load Quantification on DBS in Vietnam
A study testing Blood sampling in people with Hepatitis C and Dried Blood Spot, run by Institut Pasteur at 2 sites in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Dried Blood Spot
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 2 sitesVietnam
- Study dates
- 9 May 2019to 11 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Known HCV infection
- Willing to participate to the study by giving his/her consent.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read more
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).
Read the 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.
- Conditions
- Hepatitis C, Dried Blood Spot
- Being tested
- Blood sampling
- Keywords
- HCV Viral Load, Dried Blood Spot, HCV Core Ag
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Blood sample of 10 mL by venipuncture and 0,4 mL by finger prick
| Study group | Role | What they receive |
|---|---|---|
| Blood sampling | Other | blood samples from venepuncture (10mL) and from fingertip (approximatively 0.4mL) on a dried blood spots Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 4 weeks
Secondary outcomes (6)
Quantification of HCV RNA measured on DBS using plasma as gold standard
Sensitivity and specificity of HCV RNA VL measured on DBS collected by finger prick
Measured: Up to 4 weeks
Correlation between HCV RNA VL measured on DBS and on plasma.
Correlation between HCV RNA VL measured on DBS (collected by venipuncture and finger prick) and on plasma.
Measured: Up to 6 months
Quantification of HCV core antigen using HCV RNA VL as gold standard
Sensitivity and specificity of HCV core antigen using HCV RNA VL as gold standard
Measured: Up to 8 weeks
Correlation between HCV core antigen and HCV RNA VL on plasma
Correlation between HCV core antigen and HCV RNA VL, both measured on plasma.
Measured: Up to 6 months
Quantification of HCV core antigen measured on DBS using HCV RNA VL measured on plasma as gold standard.
Sensitivity and specificity of HCV core antigen measured on DBS collected by venipuncture using HCV RNA VL measured on plasma as gold standard.
Measured: Up to 8 weeks
Correlation between HCV core antigen measured on DBS and HCV RNA VL measured on plasma.
Correlation between HCV core antigen measured on DBS collected by venipuncture and HCV RNA VL measured on plasma.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start9 May 2019
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam, Hanoi University of Public Health
- Responsible party
- Sponsor
- Investigators
- Fabien TAIEB, MD, PhD, MPH, Principal investigator, Institut PasteurTuan Anh NGUYEN, MD, PhD, Principal investigator, National Institute of Hygiene and Epidemiology (NIHE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670251
- Sponsor's protocol ID
- 2017-076
- Acronym
- MOVIDA-Hep
- Status last verified
- Feb 2020
- First submitted
- 10 Sep 2018
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29425216Taieb 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.
PubMed 27704001Soulier 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.
PubMed 26333945Tran 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.
PubMed 31981287
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03670251
- Acronym / sponsor ID
- MOVIDA-Hep / 2017-076
- Conditions
- Hepatitis C, Dried Blood Spot
- Keywords
- HCV Viral Load, Dried Blood Spot, HCV Core Ag
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam, Hanoi University of Public Health
- Study start
- 9 May 2019 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sampling | Other | Procedure: Blood samplingblood samples from venepuncture (10mL) and from fingertip (approximatively 0.4mL) on a dried blood spots |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age
- Known HCV infection
- Willing to participate to the study by giving his/her consent.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sample of 10 mL by venipuncture and 0,4 mL by finger prick | Procedure or surgery | Blood sampling |
Primary outcome
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
6 secondary outcomes
Quantification of HCV RNA measured on DBS using plasma as gold standard
Time frame: Up to 4 weeks
Correlation between HCV RNA VL measured on DBS and on plasma.
Time frame: Up to 6 months
Quantification of HCV core antigen using HCV RNA VL as gold standard
Time frame: Up to 8 weeks
Correlation between HCV core antigen and HCV RNA VL on plasma
Time frame: Up to 6 months
Quantification of HCV core antigen measured on DBS using HCV RNA VL measured on plasma as gold standard.
Time frame: Up to 8 weeks
Correlation between HCV core antigen measured on DBS and HCV RNA VL measured on plasma.
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Background: PubMed 29425216Taieb 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.
- Background: PubMed 27704001Taieb 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.
- Background: PubMed 26333945Soulier 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.
- Results publication: PubMed 31981287Tran 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.
- WHO Guidelines on Hepatitis B and C TestingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien TAIEB, MD, PhD, MPH principal investigator
Institut Pasteur
Tuan Anh NGUYEN, MD, PhD principal investigator
National Institute of Hygiene and Epidemiology (NIHE)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Hepatitis C and Dried Blood Spot, run by Institut Pasteur at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of HCV RNA on DBS compared to plasma as gold standard (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03670251, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.