The VMVN Study: Virological Monitoring in Viet Nam

The optimal strategy for monitoring antiretroviral therapy (ART) in resource-limited settings (RLS) is unknown. In developed countries, routine monitoring with CD4 count and viral load (VL) testing is standard practice. In RLS, however, limitations in the availability of the technology for VL testing, and in financial resources to pay for VL testing, mean that few developing countries provide VL testing as part of the routine monitoring of patients on ART. Instead, ART is monitored primary by clinical examination with CD4 testing where available. This strategy has been endorsed by the most recent WHO guidelines for ART (WHO, 2010).

Standard laboratory monitoring of patients on ART in Vietnam includes CD4 testing every 6 months, where available. In many rural areas of the country, CD4 testing is not available and only clinical monitoring is used.

In this study we will test the hypothesis that routine viral monitoring every 6 months for patients on first-line ART will result in significantly higher rates of virological suppression and decrease the incidence of death or new or recurrent AIDS-defining illnesses by 50% within three years.

Inclusion criteria

• Age >= 18
• Confirmed HIV infection
• Not currently taking ART
• Meets Vietnam MOH criteria for ART (THROUGH OCTOBER 2011:CD4<250 cells/mm3, WHO Clinical Stage IV, or WHO clinical stage III with CD4<350 cells/mm3; FROM NOVEMBER 2011: CD4<350 cells/mm3, OR WHO Clinical Stage III or IV)
• Completes required Vietnam MOH ART adherence training
• Signs written informed consent form

Exclusion criteria

• Any ART use within the previous 3 months
• History of treatment failure on first-line ART or known resistance to first-line ART.
• Unable or unwilling to give written informed consent