Clinical trial NCT03249493: Monitoring Of Viral Load In Decentralised Area in Vietnam
Official title: Monitoring Of Viral Load In Decentralised Area in Vietnam : Improving Access to Viral Load Monitoring in HIV-infected Patients on ART
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Dried Blood Spot
Viral Load
Keywords: Decentralised Area
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Global Fund
name: National Institute of Hygiene and Epidemiology, Vietnam
name: Hanoi University of Public Health
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2017-08-15
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Virological success at 24 months of ART
timeFrame: 24 months (+/- 1 month) after ART initiation
Secondary outcomes:
measure: Outcomes related to DBS transfer
timeFrame: through study completion, an average of 2 years
measure: Outcomes related to quality of DBS samples
timeFrame: through study completion, an average of 2 years
measure: Outcomes related to delay concerning the return of viral load result
timeFrame: through study completion, an average of 2 years
measure: Outcomes related to ability of DBS to provide viral load result
timeFrame: through study completion, an average of 2 years
measure: Outcomes related to ability of DBS to provide HIV drug resistance result
timeFrame: through study completion, an average of 2 years
measure: Impact of viral load result on second-line ART initiation
timeFrame: through study completion, an average of 2 years
measure: Impact of viral load result on second-line ART initiation in term of delay
timeFrame: through study completion, an average of 2 years
measure: virological success at 6 and at 12 months of ART
timeFrame: At 6 and 12 months of ART
measure: Virological failure at 6, 12 and 24 months of ART
timeFrame: At 6, 12 and 24 months of ART
measure: HIV drug resistance in case of virological failure at 6, 12 and 24 months of ART
timeFrame: At 6, 12 and 24 months of ART
measure: Description of HIV drug resistance in case of virological failure at 6, 12 and 24 months of ART
timeFrame: At 6, 12 and 24 months of ART
measure: Baseline HIV drug resistance in case of virological failure
timeFrame: ART initiation
measure: Baseline HIV drug resistance
timeFrame: ART initiation
measure: Mortality
timeFrame: through study completion, an average of 2 years
measure: Attrition
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Yen Bai
country: Vietnam
facility: Yen Bai medical center
Study officials:
affiliation: Institut Pasteur
name: Fabien TAIEB, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Pasteur
name: Yoann Madec, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Nguyen 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.