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Completed

NCT Number: NCT03249493

Monitoring Of Viral Load In Decentralised Area in Vietnam

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Dried Blood Spot Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Viral Load Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yen Bai medical center

Yên Bái, Vietnam

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample on DBS

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • Global Fund
  • Hanoi University of Public Health
  • Institut National de la Santé Et de la Recherche Médicale, France
  • National Institute of Hygiene and Epidemiology, Vietnam

Registry information

Official study title

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

Acronym: MOVIDA-2

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2017
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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