Monitoring Of Viral Load In Decentralised Area in Vietnam : Improving Access to Viral Load Monitoring in HIV-infected Patients on ART
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Pasteur
- Enrollment
- 584
- Locations
- 1
- Primary Endpoint
- Virological success at 24 months of ART
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •confirmed HIV-1 infection,
- •age at enrolment ≥18 years,
- •ART naïve (women exposed through PMTCT are eligible),
- •consent to participate.
Exclusion Criteria
- •negative for HIV,
- •age at enrolment <18 years,
- •ART experienced (excepted PMTCT),
- •not consenting to participate.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Impact of viral load result on second-line ART initiation(through study completion, an average of 2 years)
- Virological failure at 6, 12 and 24 months of ART(At 6, 12 and 24 months of ART)
- Outcomes related to quality of DBS samples(through study completion, an average of 2 years)
- virological success at 6 and at 12 months of ART(At 6 and 12 months of ART)
- Mortality(through study completion, an average of 2 years)
- Outcomes related to DBS transfer(through study completion, an average of 2 years)
- Outcomes related to ability of DBS to provide viral load result(through study completion, an average of 2 years)
- Outcomes related to delay concerning the return of viral load result(through study completion, an average of 2 years)
- Impact of viral load result on second-line ART initiation in term of delay(through study completion, an average of 2 years)
- Baseline HIV drug resistance(ART initiation)
- Outcomes related to ability of DBS to provide HIV drug resistance result(through study completion, an average of 2 years)
- HIV drug resistance in case of virological failure at 6, 12 and 24 months of ART(At 6, 12 and 24 months of ART)
- Baseline HIV drug resistance in case of virological failure(ART initiation)
- Attrition(through study completion, an average of 2 years)
- Description of HIV drug resistance in case of virological failure at 6, 12 and 24 months of ART(At 6, 12 and 24 months of ART)