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Monitoring Of Viral Load In Decentralised Area in Vietnam (MOVIDA-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249493
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : January 28, 2020
Sponsor:
Collaborators:
Global Fund
National Institute of Hygiene and Epidemiology, Vietnam
Hanoï University of Public Health
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Institut Pasteur

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.


Condition or disease Intervention/treatment
HIV/AIDS Dried Blood Spot Viral Load Other: Blood sample on DBS

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.

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Study Type : Observational
Estimated Enrollment : 584 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring Of Viral Load In Decentralised Area in Vietnam : Improving Access to Viral Load Monitoring in HIV-infected Patients on ART
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : August 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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
Other: Blood sample on DBS

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


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
Other: Blood sample on DBS

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





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Outcomes related to DBS transfer [ Time Frame: through study completion, an average of 2 years ]
    • Delay (days) between DBS collection and transfer to central laboratory
    • Delay (days) between DBS collection and reception at central laboratory

  2. Outcomes related to quality of DBS samples [ Time Frame: through study completion, an average of 2 years ]
    - Aspect of DBS at reception at central laboratory (qualitative evaluation)

  3. Outcomes related to delay concerning the return of viral load result [ Time Frame: through study completion, an average of 2 years ]
    • 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

  4. Outcomes related to ability of DBS to provide viral load result [ Time Frame: through study completion, an average of 2 years ]
    - Proportion of DBS not allowing viral load quantification (number of DBS not allowing VL quantification/total number of DBS samples)

  5. Outcomes related to ability of DBS to provide HIV drug resistance result [ Time Frame: through study completion, an average of 2 years ]
    - 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)

  6. Impact of viral load result on second-line ART initiation [ Time Frame: through study completion, an average of 2 years ]
    - Number of patients who initiate second-line ART during the study

  7. Impact of viral load result on second-line ART initiation in term of delay [ Time Frame: through study completion, an average of 2 years ]
    - Delay (days) between reception of the viral load results at the care site and second-line ART initiation

  8. virological success at 6 and at 12 months of ART [ Time Frame: At 6 and 12 months of ART ]
    Patients with a VL <1000 copies/mL at 6 and at 12 months of ART

  9. Virological failure at 6, 12 and 24 months of ART [ Time Frame: 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)

  10. 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 ]
    - Proportion of patients in virological failure and for whom the virus is harbouring HIV drug resistances

  11. 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 ]
    - Profiles of HIV durg resistance in patients in virological failure

  12. Baseline HIV drug resistance in case of virological failure [ Time Frame: ART initiation ]
    - 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

  13. Baseline HIV drug resistance [ Time Frame: ART initiation ]
    - proportion of patients for whom the virus presented HIV drug resistance at ART initiation, in a random selection of patients enrolled

  14. Mortality [ Time Frame: through study completion, an average of 2 years ]
    Patients who died while on ART during the follow-up

  15. Attrition [ Time Frame: through study completion, an average of 2 years ]
    patients who are lost to follow-up (not seen for >3 months) after they initiated ART


Biospecimen Retention:   Samples With DNA
Whole blood samples on Dried Blood spot cards


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249493


Contacts
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Contact: Tuan Anh Nguyen, PhD +849 13562981 nat@nihe.org.vn
Contact: Hien T Ho, MD, PhD +849 13542882 hienthiho@gmail.com

Locations
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Vietnam
Yen Bai medical center Recruiting
Yen Bai City, Vietnam
Contact: Hue T Due         
Sponsors and Collaborators
Institut Pasteur
Global Fund
National Institute of Hygiene and Epidemiology, Vietnam
Hanoï University of Public Health
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Fabien TAIEB, MD Institut Pasteur
Principal Investigator: Yoann Madec, PhD Institut Pasteur
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03249493    
Other Study ID Numbers: 2016-001
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Non applicable

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Pasteur:
Decentralised Area
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases