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

NCT04794725 | Completed

• 1 other identifier: 2020-067
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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

Conditions

HIV Infections

Keywords

Viral Load Monitoring, Dried Blood Spot

Outcome Measures

Primary Outcomes (1)

• 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)

  up to 4 weeks

Secondary Outcomes (1)

• Correlation between HIV RNA VL measured on DBS and on plasma

  up to 4 weeks

Study Arms (1)

Blood Sampling

OTHER

blood samples from venepuncture (10mL)

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

blood samples from venepuncture (10mL)

Blood Sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Institut Pasteur: lead
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator

Study Sites (2)

Dong Da

Hanoi, Vietnam

Location

Nam Tu Liem

Hanoi, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 32271796 BACKGROUND

• 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.

  PMID: 29425216 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yoann MADEC, PhD

  Institut Pasteur

  STUDY DIRECTOR

• Tuan Anh NGUYEN, MD, PhD

  National Institute of Hygiene and Epidemiology, Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: October 5, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)