Monitoring Of Viral Load In Decentralised Area in Vietnam

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. 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.

Official Title
-----------------
Monitoring Of Viral Load In Decentralised Area in Vietnam : Improving Access to Viral Load Monitoring in HIV-infected Patients on ART

Conditions
-----------------
HIV/AIDS, Dried Blood Spot, Viral Load

Intervention / Treatment
-----------------
* Other: Blood sample on DBS


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV Injection drug users<br>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 | Other: Blood sample on DBS<br>* 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<br>|
| HIV Non injection drug users<br>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 | Other: Blood sample on DBS<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virological success at 24 months of ART | Patients with a VL <1000 copies/mL at 24 months of ART | 24 months (+/- 1 month) after ART initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 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) | 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) | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | ART initiation | 
| Mortality | Patients who died while on ART during the follow-up | 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 | through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decentralised Area