MOVIDA1-Ter: MOVIDA 1 Ter - Evaluation of the Cobas® Plasma Separation Card in the Field in Vietnam
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Blood Sampling blood samples from venepuncture (10mL) |
Procedure: Blood sampling
blood samples from venepuncture (10mL)
|
Outcome Measures
Primary Outcome Measures
- Quantification of HIV RNA on DBS compared to plasma as gold standard [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 Outcome Measures
- Correlation between HIV RNA VL measured on DBS and on plasma [up to 4 weeks]
Comparison of quantitative HIV VL results obtained on plasma and when using the cobas® PSC
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥18 years of age
-
HIV-1 infected adults
-
Willing to participate to the study by giving his/her consent
Exclusion Criteria:
- None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institut Pasteur
- National Institute of Hygiene and Epidemiology - Vietnam (NIHE)
Investigators
- Study Director: Yoann MADEC, PhD, Institut Pasteur
- Principal Investigator: Tuan Anh NGUYEN, MD, PhD, National Institute of Hygiene and Epidemiology, Vietnam
Study Documents (Full-Text)
None provided.More Information
Publications
- Nguyen TA, Tran TH, Nguyen BT, Pham TTP, Hong Le NT, Ta DV, Phan HTT, Nguyen LH, Ait-Ahmed M, Ho HT, Taieb F, Madec Y; MOVIDA 2 study group. Feasibility of dried blood spots for HIV viral load monitoring in decentralized area in North Vietnam in a test-and-treat era, the MOVIDA project. PLoS One. 2020 Apr 9;15(4):e0230968. doi: 10.1371/journal.pone.0230968. eCollection 2020.
- Taieb F, Tran Hong T, Ho HT, Nguyen Thanh B, Pham Phuong T, Viet Ta D, Le Thi Hong N, Ba Pham H, Nguyen LTH, Nguyen HT, Nguyen TT, Tuaillon E, Delaporte E, Le Thi H, Tran Thi Bich H, Nguyen TA, Madec Y. First field evaluation of the optimized CE marked Abbott protocol for HIV RNA testing on dried blood spot in a routine clinical setting in Vietnam. PLoS One. 2018 Feb 9;13(2):e0191920. doi: 10.1371/journal.pone.0191920. eCollection 2018.
- 2020-067