HIV/AIDSMOVIDA-2NCT03249493
Monitoring Of Viral Load In Decentralised Area in Vietnam
An observational study of HIV/AIDS and Dried Blood Spot, run by Institut Pasteur at 1 site in Vietnam.
Trial summary
As of today, HIV-infected patients followed in decentralized area have little or even no access to viral load monitoring because laboratories able to perform this biological measurement are only in large cities, and because plasma transfer to these laboratories is complex and very costly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Dried Blood Spot, Viral Load
- What is being tested?
- Blood sample on DBS
- How many people
- 584 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Aug 2017to 1 Sep 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The key population for this research project is HIV-positive patients who initiate ART followed in 24 out-patient clinics (OPCs) located in decentralised areas in two provinces, where laboratories facilities are not easily accessible and where VL monitoring is extremely scarce.
Who may be able to join
- confirmed HIV-1 infection,
- age at enrolment ≥18 years,
- ART naïve (women exposed through PMTCT are eligible),
- consent to participate.
Who cannot join
- negative for HIV,
- age at enrolment <18 years,
- ART experienced (excepted PMTCT),
- not consenting to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Of Viral Load In Decentralised Area in Vietnam : Improving Access to Viral Load Monitoring in HIV-infected Patients on ART
As of today, HIV-infected patients followed in decentralized area have little or even no access to viral load monitoring because laboratories able to perform this biological measurement are only in large cities, and because plasma transfer to these laboratories is complex and very costly.
Blood sampling using dried blood spots (DBS) could overcome these difficulties. The goal of this operational research is to document the feasibility of DBS use in decentralised area to monitor viral load, to evaluate the virological response on ART, and to compare the virological response between injecting drug users (IDU) and the other patients, as IDU represent a large proportion of HIV-infected patients who may have a lower access/adherence to care.
Read the detailed description
The MOVIDA project is a longitudinal observational study enrolling patients who initiate ART in decentralized areas requiring individual data and blood samples collected in routine HIV care.
This project aims at evaluating and providing operability data of the use of Dried Blood Spots (DBS) as sampling tool to measure and monitor the HIV viral load in real life in rural decentralized areas in Vietnam.
This operational project would contribute to:
- the provision of viral load measurements in patients from rural decentralized areas,
- the improvement of the proportion of patients in virological success on ART, and hence to reduce the proportion of patients with acquired HIV drug resistance,
- the improvement of general HIV care and to establish an observatory of HIV drug resistance,
- strengthen national capacities through capitalization and exchange of good practices of blood sampling using DBS system to expand to other indications than HIV VL measurement.
To achieve this goal, clinical and laboratory staff will be trained to the management of the MOVIDA project (enrollment of patients; sample collection, management and analysis; data collection) before the operational observational study. Patients on the antiretroviral (ART) initiation visit will be informed about the study and invited to participate, before collection of blood to prepare DBS and collection of clinical data already routinely collected in the patient medical records. The blood collection (5ml) will be repeated at 6, 12 and 24 months during follow-up visits already planned according to the current national guidelines for the ART delivery.
The samples collected (5ml of blood) will be analyzed in a local central laboratory using the m2000rt Abbott techniques. Analysis results (VL and when necessary HIV Drug Resistance genotyping) will be available to the medical doctor in order to adapt the patient treatment appropriately. A set of randomly selected DBS will be shipped to France for centralized quality control analyses.
A socio-anthropological qualitative study will also be implemented targeting patients, health-care staff and peer health workers to apprehend their understanding of VL, and to better define determinants of adherence and attendance to clinical visits. This will help local health authorities adapt the messages and the initiatives to improve adherence to ART and attendance to care follow-up.
The study duration is 36 months with a 6 months period of enrollment and will be conducted in 6 provinces where 1000 patients are to be enrolled.
- Conditions
- HIV/AIDS, Dried Blood Spot, Viral Load
- Being tested
- Blood sample on DBS
- Keywords
- Decentralised Area
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample on DBSOther
We will take 5 mL of whole blood at ART initiation, 6, 12 and 24 months of follow up after ART initiation. Blood will be transferred on DBS cards.
HIV Viral Load measurements will be done and HIV Drug Resistance measurements will be performed in case of 2 consecutive VL results > 1000 cp/mL
| Study group | Role | What they receive |
|---|---|---|
| HIV Injection drug users | Blood sample on DBS. Blood sample for HIV Viral Load measurements and HIV Drug Resistance at baseline, 6, 12 and 24 months of follow up after ART initiation using Dried Blood Spot Receives: Other: Blood sample on DBS | |
| HIV Non injection drug users | Blood sample on DBS. Blood sample for HIV Viral Load measurements and HIV Drug Resistance at baseline, 6, 12 and 24 months of follow up after ART initiation using Dried Blood Spot Receives: Other: Blood sample on DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological success at 24 months of ART
Patients with a VL <1000 copies/mL at 24 months of ART
Measured: 24 months (+/- 1 month) after ART initiation
Secondary outcomes (15)
Outcomes related to DBS transfer
- Delay (days) between DBS collection and transfer to central laboratory
- Delay (days) between DBS collection and reception at central laboratory
Measured: through study completion, an average of 2 years
Outcomes related to quality of DBS samples
- Aspect of DBS at reception at central laboratory (qualitative evaluation)
Measured: through study completion, an average of 2 years
Outcomes related to delay concerning the return of viral load result
- Delay (days) between reception at central laboratory and viral load quantification
- Delay (days) between DBS collection and reception of the result at the care site
Measured: through study completion, an average of 2 years
Outcomes related to ability of DBS to provide viral load result
- Proportion of DBS not allowing viral load quantification (number of DBS not allowing VL quantification/total number of DBS samples)
Measured: through study completion, an average of 2 years
Outcomes related to ability of DBS to provide HIV drug resistance result
- Proportion of DBS not allowing HIV drug resistance (number of DBS not allowing HIV drug resistance /total number of DBS samples with VL confirmed>1000cp/mL)
Measured: through study completion, an average of 2 years
Impact of viral load result on second-line ART initiation
- Number of patients who initiate second-line ART during the study
Measured: through study completion, an average of 2 years
Impact of viral load result on second-line ART initiation in term of delay
- Delay (days) between reception of the viral load results at the care site and second-line ART initiation
Measured: through study completion, an average of 2 years
virological success at 6 and at 12 months of ART
Patients with a VL <1000 copies/mL at 6 and at 12 months of ART
Measured: At 6 and 12 months of ART
Virological failure at 6, 12 and 24 months of ART
- Proportion of patients with 2 consecutive viral load >= 1000 copies/mL (the second viral load being measured within 2 to 3 months from the first one after strengthening of adherence)
Measured: At 6, 12 and 24 months of ART
HIV drug resistance in case of virological failure at 6, 12 and 24 months of ART
- Proportion of patients in virological failure and for whom the virus is harbouring HIV drug resistances
Measured: At 6, 12 and 24 months of ART
Description of HIV drug resistance in case of virological failure at 6, 12 and 24 months of ART
- Profiles of HIV durg resistance in patients in virological failure
Measured: At 6, 12 and 24 months of ART
Baseline HIV drug resistance in case of virological failure
- Proportion of patients identified in virological failure during the follow-up on ART, and for whom the virus presented HIV drug resistance at ART initiation
Measured: ART initiation
Baseline HIV drug resistance
- proportion of patients for whom the virus presented HIV drug resistance at ART initiation, in a random selection of patients enrolled
Measured: ART initiation
Mortality
Patients who died while on ART during the follow-up
Measured: through study completion, an average of 2 years
Attrition
patients who are lost to follow-up (not seen for >3 months) after they initiated ART
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start15 Aug 2017
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Global Fund, National Institute of Hygiene and Epidemiology, Vietnam, Hanoi University of Public Health, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Fabien TAIEB, MD, Principal investigator, Institut PasteurYoann Madec, PhD, Principal investigator, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249493
- Sponsor's protocol ID
- 2016-001
- Acronym
- MOVIDA-2
- Status last verified
- Mar 2021
- First submitted
- 7 Aug 2017
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Non applicable
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 27704001Nguyen TA, Tran TH, Nguyen BT, Pham TTP, Hong Le NT, Ta DV, Phan HTT, Nguyen LH, Ait-Ahmed M, Ho HT, Taieb F, Madec Y; MOVIDA 2 study group. Feasibility of dried blood spots for HIV viral load monitoring in decentralized area in North Vietnam in a test-and-treat era, the MOVIDA project. PLoS One. 2020 Apr 9;15(4):e0230968. doi: 10.1371/journal.pone.0230968. eCollection 2020.
PubMed 32271796Araujo Chaveron L, Pham TTP, Nguyen BT, Tran TH, Le NTH, Pham TH, Ngo KP, Tong HT, Phan HTT, Ait-Ahmed M, Nguyen TA, Taieb F, Madec Y; MOVIDA 2 study group. Injecting drug use increases the risk of death in HIV patients on antiretroviral therapy in Vietnam. AIDS Care. 2024 May;36(5):631-640. doi: 10.1080/09540121.2023.2224549. Epub 2023 Jun 20.
PubMed 37339000Lefrancois LH, Nguyen BT, Pham TTP, Le NTH, Dao HTT, Tran TH, Ngo KP, Tong HT, Phan HTT, Ait-Ahmed M, Pham TH, Nguyen TA, Taieb F, Madec Y; MOVIDA 2 study group. Assessment of HIV viral load monitoring in remote settings in Vietnam - comparing people who inject drugs to the other patients. PLoS One. 2023 Feb 21;18(2):e0281857. doi: 10.1371/journal.pone.0281857. eCollection 2023.
PubMed 36802388
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Of Viral Load In Decentralised Area in Vietnam : Improving Access to Viral Load Monitoring in HIV-infected Patients on ART
- ClinicalTrials.gov ID
- NCT03249493
- Acronym / sponsor ID
- MOVIDA-2 / 2016-001
- Conditions
- HIV/AIDS, Dried Blood Spot, Viral Load
- Keywords
- Decentralised Area
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Global Fund, National Institute of Hygiene and Epidemiology, Vietnam, Hanoi University of Public Health, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 15 Aug 2017 (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.
As of today, HIV-infected patients followed in decentralized area have little or even no access to viral load monitoring because laboratories able to perform this biological measurement are only in large cities, and because plasma transfer to these laboratories is complex and very costly.
Blood sampling using dried blood spots (DBS) could overcome these difficulties. The goal of this operational research is to document the feasibility of DBS use in decentralised area to monitor viral load, to evaluate the virological response on ART, and to compare the virological response between injecting drug users (IDU) and the other patients, as IDU represent a large proportion of HIV-infected patients who may have a lower access/adherence to care.
Detailed description
The MOVIDA project is a longitudinal observational study enrolling patients who initiate ART in decentralized areas requiring individual data and blood samples collected in routine HIV care.
This project aims at evaluating and providing operability data of the use of Dried Blood Spots (DBS) as sampling tool to measure and monitor the HIV viral load in real life in rural decentralized areas in Vietnam.
This operational project would contribute to:
- the provision of viral load measurements in patients from rural decentralized areas,
- the improvement of the proportion of patients in virological success on ART, and hence to reduce the proportion of patients with acquired HIV drug resistance,
- the improvement of general HIV care and to establish an observatory of HIV drug resistance,
- strengthen national capacities through capitalization and exchange of good practices of blood sampling using DBS system to expand to other indications than HIV VL measurement.
To achieve this goal, clinical and laboratory staff will be trained to the management of the MOVIDA project (enrollment of patients; sample collection, management and analysis; data collection) before the operational observational study. Patients on the antiretroviral (ART) initiation visit will be informed about the study and invited to participate, before collection of blood to prepare DBS and collection of clinical data already routinely collected in the patient medical records. The blood collection (5ml) will be repeated at 6, 12 and 24 months during follow-up visits already planned according to the current national guidelines for the ART delivery.
The samples collected (5ml of blood) will be analyzed in a local central laboratory using the m2000rt Abbott techniques. Analysis results (VL and when necessary HIV Drug Resistance genotyping) will be available to the medical doctor in order to adapt the patient treatment appropriately. A set of randomly selected DBS will be shipped to France for centralized quality control analyses.
A socio-anthropological qualitative study will also be implemented targeting patients, health-care staff and peer health workers to apprehend their understanding of VL, and to better define determinants of adherence and attendance to clinical visits. This will help local health authorities adapt the messages and the initiatives to improve adherence to ART and attendance to care follow-up.
The study duration is 36 months with a 6 months period of enrollment and will be conducted in 6 provinces where 1000 patients are to be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV Injection drug users | – | Other: Blood sample on DBSBlood sample on DBS. Blood sample for HIV Viral Load measurements and HIV Drug Resistance at baseline, 6, 12 and 24 months of follow up after ART initiation using Dried Blood Spot |
| HIV Non injection drug users | – | Other: Blood sample on DBSBlood sample on DBS. Blood sample for HIV Viral Load measurements and HIV Drug Resistance at baseline, 6, 12 and 24 months of follow up after ART initiation using Dried Blood Spot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The key population for this research project is HIV-positive patients who initiate ART followed in 24 out-patient clinics (OPCs) located in decentralised areas in two provinces, where laboratories facilities are not easily accessible and where VL monitoring is extremely scarce.
Key inclusion criteria (4 listed)
- confirmed HIV-1 infection,
- age at enrolment ≥18 years,
- ART naïve (women exposed through PMTCT are eligible),
- consent to participate.
Key exclusion criteria (4 listed)
- negative for HIV,
- age at enrolment <18 years,
- ART experienced (excepted PMTCT),
- not consenting to participate.
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 sample on DBSWe will take 5 mL of whole blood at ART initiation, 6, 12 and 24 months of follow up after ART initiation. Blood will be transferred on DBS cards. HIV Viral Load measurements will be done and HIV Drug Resistance measurements will be performed in case of 2 consecutive VL results > 1000 cp/mL | Other | HIV Injection drug users, HIV Non injection drug users |
Primary outcome
Virological success at 24 months of ART
Time frame: 24 months (+/- 1 month) after ART initiation
Patients with a VL <1000 copies/mL at 24 months of ART
15 secondary outcomes
Outcomes related to DBS transfer
Time frame: through study completion, an average of 2 years
Outcomes related to quality of DBS samples
Time frame: through study completion, an average of 2 years
Outcomes related to delay concerning the return of viral load result
Time frame: through study completion, an average of 2 years
Outcomes related to ability of DBS to provide viral load result
Time frame: through study completion, an average of 2 years
Outcomes related to ability of DBS to provide HIV drug resistance result
Time frame: through study completion, an average of 2 years
Impact of viral load result on second-line ART initiation
Time frame: through study completion, an average of 2 years
Impact of viral load result on second-line ART initiation in term of delay
Time frame: through study completion, an average of 2 years
virological success at 6 and at 12 months of ART
Time frame: At 6 and 12 months of ART
Virological failure at 6, 12 and 24 months of ART
Time frame: At 6, 12 and 24 months of ART
HIV drug resistance in case of virological failure at 6, 12 and 24 months of ART
Time frame: At 6, 12 and 24 months of ART
Description of HIV drug resistance in case of virological failure at 6, 12 and 24 months of ART
Time frame: At 6, 12 and 24 months of ART
Baseline HIV drug resistance in case of virological failure
Time frame: ART initiation
Baseline HIV drug resistance
Time frame: ART initiation
Mortality
Time frame: through study completion, an average of 2 years
Attrition
Time frame: through study completion, an average of 2 years
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 20 May 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.
- Results publication: PubMed 32271796Nguyen TA, Tran TH, Nguyen BT, Pham TTP, Hong Le NT, Ta DV, Phan HTT, Nguyen LH, Ait-Ahmed M, Ho HT, Taieb F, Madec Y; MOVIDA 2 study group. Feasibility of dried blood spots for HIV viral load monitoring in decentralized area in North Vietnam in a test-and-treat era, the MOVIDA project. PLoS One. 2020 Apr 9;15(4):e0230968. doi: 10.1371/journal.pone.0230968. eCollection 2020.
- Derived from this study: PubMed 37339000Araujo Chaveron L, Pham TTP, Nguyen BT, Tran TH, Le NTH, Pham TH, Ngo KP, Tong HT, Phan HTT, Ait-Ahmed M, Nguyen TA, Taieb F, Madec Y; MOVIDA 2 study group. Injecting drug use increases the risk of death in HIV patients on antiretroviral therapy in Vietnam. AIDS Care. 2024 May;36(5):631-640. doi: 10.1080/09540121.2023.2224549. Epub 2023 Jun 20.
- Derived from this study: PubMed 36802388Lefrancois LH, Nguyen BT, Pham TTP, Le NTH, Dao HTT, Tran TH, Ngo KP, Tong HT, Phan HTT, Ait-Ahmed M, Pham TH, Nguyen TA, Taieb F, Madec Y; MOVIDA 2 study group. Assessment of HIV viral load monitoring in remote settings in Vietnam - comparing people who inject drugs to the other patients. PLoS One. 2023 Feb 21;18(2):e0281857. doi: 10.1371/journal.pone.0281857. eCollection 2023.
- Individual participant dataSharing planned: No. Non applicable
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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 principal investigator
Institut Pasteur
Yoann Madec, PhD principal investigator
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS and Dried Blood Spot, run by Institut Pasteur at 1 site 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 4 inclusion and 4 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 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Virological success at 24 months of ART (time frame: 24 months (+/- 1 month) after ART initiation). 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 NCT03249493, which also lists 5 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 20 May 2022.