More than 5.6 million people are estimated to be living with HIV in South Africa, the largest epidemic in the world. A substantial proportion (45%) of these are believed to be eligible for initiation of antiretroviral therapy (ART), but despite a major government effort, many are not aware of their HIV status and only 55% of eligible patients are receiving life saving treatment. Community-based voluntary counseling and testing for HIV is a new strategy for improving HIV testing rates, diagnosing patients earlier in the course of disease with the potential to link patients to care and treatment with ART and to reduce HIV morbidity and mortality. A major obstacle to ART initiation among newly diagnosed HIV patients in sub-Saharan Africa is CD4 cell count staging to determine eligibility for treatment. In South Africa, CD4 cell testing is performed in centralized laboratories, requiring sophisticated and expensive laboratory infrastructure and currently, senior level nurses to draw blood. Hard to reach individuals living in impoverished rural areas have limited access to both CD4 cell testing facilities and to the professional nurses required to obtain the blood for analysis. Rapid CD4 cell point of care (POC) diagnostics has the potential to substantially reduce delays associated with CD4 count staging and to facilitate linkage to care. The PIMA diagnostic analyzer can provide an accurate CD4 cell count in 20 minutes and can utilize finger stick obtained samples. In addition, PIMA is portable, simple and relatively inexpensive. POC CD4 testing in a community setting can ensure CD4 results are available immediately after HIV diagnosis. Furthermore, the use of capillary blood for PIMA analysis would allow for task shifting from professional nurses to HIV counselors thereby reducing costs, promoting decentralization of HIV services and freeing nurses to initiate ART and other critical and more expert services. We propose to perform an operational research study of the implementation of the PIMA POC test nested into an existing successful integrated HIV/TB community based case finding platform in an impoverished rural South African region with extremely high HIV prevalence and mortality. Mobile teams which currently perform HIV testing at community congregate settings will be utilized. The implementation measures to be studied include 1) comparison of flow cytometry on venous blood to PIMA analysis of fingerstick capillary blood 2) comparison of nurses and HIV counselors performing PIMA fingerstick capillary blood testing and 3) feasibility and acceptance of the PIMA fingerstick testing in a remote rural area and 4) estimation of the time saved to ART initiation with use of PIMA. The study will be performed by a US and South African team that has successfully collaborated on HIV studies for a decade. It has the potential for providing the evidence to support task shifting of scarce human resources, increase HIV case finding, access to care, and ART provision in an underserved rural area. This project will inform public health policy and practice in high HIV prevalence resource limited settings globally.

Public Health Relevance

PAR-10-040 Rapid point of care CD4 diagnostics can reduce the delays associated with CD4 staging for antiretroviral therapy initiation among newly diagnosed HIV patients in sub-Saharan Africa. This proposal will demonstrate that use of fingerstick obtained capillary blood for rapid point of care CD4 testing by a new technology can be performed by HIV counselors instead of highly trained nurses and can facilitate task shifting and decentralization of HIV services. This project has the potential to inform public health policy and practice in high HIV prevalence resource limited settings and to expand antiretroviral access and treatment in sub Saharan Africa and globally.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Exploratory/Developmental Grants (R21)
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Special Emphasis Panel (ZRG1-AARR-G (93))
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Livnat, Daniella
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Yale University
Internal Medicine/Medicine
Schools of Medicine
New Haven
United States
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