Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-06 @ 6:25 PM
Study NCT ID:
NCT03249493
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2017-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Of Viral Load In Decentralised Area in Vietnam
Sponsor:
Institut Pasteur
Organization:
Study Overview
Official Title:
Monitoring Of Viral Load In Decentralised Area in Vietnam : Improving Access to Viral Load Monitoring in HIV-infected Patients on ART
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOVIDA-2
Brief 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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: