An interventional study of Blood sampling in HIV Infections, sponsored by Institut Pasteur. Completed at 2 sites in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Institut Pasteur · Not applicable, Interventional, and Diagnostic
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
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).
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 250 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Institut Pasteur is the lead sponsor of 96 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
blood samples from venepuncture (10mL)
Procedure: Blood sampling
blood samples from venepuncture (10mL)
Quantification of HIV RNA on DBS compared to plasma as gold standard
sensitivity and specificity of the Cobas® PSC against plasma (as gold standard) at to identify virological failure (HIV VL ≥1000 copies/mL)
Time frame: up to 4 weeks
Correlation between HIV RNA VL measured on DBS and on plasma
Comparison of quantitative HIV VL results obtained on plasma and when using the cobas® PSC
Time frame: up to 4 weeks
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Institut Pasteur