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Evaluation of HCV Care and Treatment for HIV-HCV Co-infected Patients in Decentralised Areas in Vietnam

NCT05506475 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-03-06

No results posted yet for this study

Summary

With the advent of direct acting antiviral (DAA) treatment in 2013, HCV elimination has become feasible. Still, achieving HCV elimination in resource-limited countries appears to be arduous as several challenges need to be addressed.

In remote settings, absence of HCV VL testing to identify those who require DAA and to monitor DAA success is a first issue. As of today, HCV VL testing is still restricted to central facilities in major cities. Blood sampling using DBS is an appealing option to allow HCV VL monitoring in remote settings as this option is inexpensive, does not require a cold chain for storage and transportation of the samples and can be implemented rapidly.

A second issue is DAA access that remains scarce due to logistical and financial limitations. However, more affordable generic DAA, some of them being WHO pre-qualified, are now available.

Vietnam is amongst the 20 countries with the highest HCV burden with an estimate of 1.5 million chronic HCV-infected people (HCV prevalence: 1.1%). As observed in many other settings, HCV prevalence is higher among vulnerable populations such as HIV-infected individuals and people who inject drugs (PWID).

Vietnam has the will to increase access to DAA in the whole country. However, in remote settings, only some clinical sites will be allowed to dispense DAA. Discussions with the MoH of Vietnam brought to our knowledge that not all clinical sites caring for HIV patients and providing ART will dispense DAA.

Thus, some HIV-HCV co-infected patients will be followed in clinical sites where they will receive both antiretroviral therapy and DAA, while some other patients will continue to be followed for HIV in their usual clinical site but will be asked to visit another clinical site for HCV care and to receive DAA. We anticipate that the proportion of patients who will comply with the 12-week DAA will be lower in patients followed for HIV and HCV in two clinical sites than in those followed in a single clinical site.

Conditions

  • HIV Infection
  • Hepatitis C Infection

Interventions

PROCEDURE

Blood samples

venous blood collected in a 5 mL EDTA tube

Sponsors & Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER

  • ANRS, Emerging Infectious Diseases

    collaborator OTHER_GOV

  • Institut Pasteur

    lead INDUSTRY

Principal Investigators

  • Yoann MADEC, PhD · Institut Pasteur

  • Tuan Anh NGUYEN, PhD · National Institute of Hygiene and Epidemiology, Vietnam

  • Thang Hong PHAM, PhD · National Institute of Hygiene and Epidemiology, Vietnam

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05506475 on ClinicalTrials.gov