HIV Viral Load Monitoring in Resource-Poor Settings

Inclusion Criteria:

• Documented HIV-1 infection (according to local standard rapid testing algorithms)
• Age 18 years or greater
• Able and willing to provide informed consent to participate

• Eligible for antiretroviral therapy per Zambian national guidelines, which are any of the following:

  • CD4+ cell count less than 200 cells/mm3;
  • WHO Stage IV disease; or
  • WHO Stage III disease and CD4+ cell count less than 350 cells/mm3
• Residence in the geographical catchment area of the VLS clinic and intent to remain there for the duration of the study
• Willingness to adhere to the study visit schedule and to be followed-up at home in the event of a missed study visit
• Initiating ART on the day of VLS enrollment, informed consent, and baseline blood collection

Exclusion Criteria:

• Receipt of more than 7 days (cumulative) of prior antiretroviral therapy at any time prior to study entry, with the exception of zidovudine and/or single dose nevirapine for prevention of mother-to-child transmission;
• Any exposure to antiretroviral therapy in the past one month
• A condition that, in the opinion of the investigators, would interfere with adherence to study requirements (e.g., mental illness or active drug or alcohol use or dependence)
• Serious illness requiring referral to hospital at the time of ART initiation
• For patients seeking care at sites randomized to the standard of care arm: participation in another research protocol that offers routine viral load testing
• Unwillingness to consent to all aspects of study protocol including blood specimen storage