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NCT Number: NCT04794725

MOVIDA 1 Ter - Evaluation of the Cobas® Plasma Separation Card in the Field in Vietnam

In low- and middle-income countries, viral load (VL) monitoring of patients living with HIV and followed on antiretroviral therapy (ART) in remote settings is still scarce. Barriers to VL monitoring are essentially the limited access to a laboratory able to perform this measurement, its cost, as well as the lack of human and material resources. Blood sampling using dried blood spots (DBS), which has been validated and is immediately available, could overcome these barriers. With DBS, transfer and conservation of samples are simplified enabling access to VL monitoring to patients seeking care in sites far from laboratory facilities. Use of DBS also offers the advantage not to require extensive investments.

To guide decision makers in the implementation of strategies to scale-up HIV VL monitoring in remote settings, field evaluations of DBS in routine conditions are needed. It is in this context that we propose this field evaluation of the Cobas® plasma separation card in Vietnam

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dong Da, Hanoi, Vietnam

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About this study

In Vietnam, in 2018, HIV prevalence was estimated at 0.3% among adults and the estimated proportion of PLHIV on ART was 65%, however the HIV epidemic is essentially concentrated in people who inject drugs, men who have sex with men and sex workers.

As of today, routine HIV VL monitoring is not yet available in remote settings in Vietnam. Despite an initiative we conducted and that documented the feasibility of DBS use in remote settings, and although no genuine roll-out of POC machines is yet observed in the field, the Ministry of Health of Vietnam has not yet decided to scale-up HIV VL monitoring using DBS. More field evaluations are needed to convince the Ministry of Health that DBS can effectively be used to scale-up HIV VL monitoring.

The aim of the present study is to evaluate the sensitivity and specificity of HIV VL measurement using the cobas® plasma separation card (PSC) against plasma at the threshold of 1000 copies/mL (threshold currently used to define failure in Vietnam, following the WHO guidelines).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥18 years of age
  • HIV-1 infected adults
  • Willing to participate to the study by giving his/her consent

Exclusion criteria

  • None

Treatment and study plan

blood sampling

Procedure

blood samples from venepuncture (10mL)

Primary outcomes

  1. Quantification of HIV RNA on DBS compared to plasma as gold standard

    Time frame: up to 4 weeks

    sensitivity and specificity of the Cobas® PSC against plasma (as gold standard) at to identify virological failure (HIV VL ≥1000 copies/mL)

Secondary outcomes

  1. Correlation between HIV RNA VL measured on DBS and on plasma

    Time frame: up to 4 weeks

    Comparison of quantitative HIV VL results obtained on plasma and when using the cobas® PSC

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

Registry information

Official study title

Monitoring Of Viral Load In Decentralised Area 1 Ter - Evaluation of the Cobas® Plasma Separation Card in the Field in Vietnam

Acronym: MOVIDA1-Ter

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2021
Registry last updated
Mar 6, 2024

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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