HIV Viral Load Monitoring in Resource-Poor Settings
HIV, AIDS, HIV Infections
About this trial
This is an interventional health services research trial for HIV focused on measuring HIV, AIDS, Zambia, viral load, antiretroviral therapy, cluster randomization, ART monitoring, treatment failure, randomized clinical trial, treatment naive
Eligibility Criteria
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
Sites / Locations
- Centre for Infectious Disease Research in Zambia
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Standard of care
Routine HIV-1 viral load testing
Standard of care arm: utilizes the current standard of care per Zambian national guidelines to determine treatment failure and eligibility for second-line ART. HIV-1 viral load measurement is performed if the criteria for either immunologic (i.e., CD4+ lymphocyte count-based) or clinical treatment failure are fulfilled. If both immunologic and clinical treatment failure criteria are fulfilled, the ART regimen is changed to second-line without VL testing.
Routine viral load testing arm: Routine HIV viral load testing at ART initiation (baseline) and at 3, 6, 12, 18, 24, 30 and 36 months thereafter.