Performance of an innovative, instrument-free, low-cost, rapid point-of-care CD4 test for accelerating initiation of antiretroviral interventions for HIV 1-infected pregnant women in resource-constrained settings
HIV infection accounts for 9% of deaths of pregnant women in sub-Saharan Africa (42.5% in South Africa) and substantially hinders progress towards reducing maternal mortality. HIV infection during pregnancy also contributes to poor perinatal health outcomes (stillbirth, preterm birth, low birth weight, HIV infection). Poor uptake and delayed initiation of antiretroviral interventions are the principal determinants of HIV infection of infants and HIV-related maternal deaths. Assessing CD4 count at first antenatal visit for HIV-infected women using rapid point-of-care (POC) CD4 testing would allow immediate initiation of antiretroviral intervention, either for the mother's own health or for the prevention of mother-to-child transmission, substantially reducing maternal and child deaths. A simple and accurate instrument-free, low-cost POC CD4 test that is applicable in poor, hard-to-reach settings could sustainably increase uptake of antiretroviral intervention and reduce loss to follow-up associated with centralized laboratory-based testing. Four antenatal care clinics in Kenya and South Africa will enroll 275 HIV-infected pregnant women to prospectively assess the accuracy of the novel, rapid, inexpensive ($1.50) and instrument-free Burnet POC CD4 test as performed by nurse-midwives in field settings, compared to a WHO pre-qualified POC CD4 instrument-based (PIMA) and a laboratory-based flow cytometric assay. If proven accurate in field settings, the Burnet POC CD4 test could be rapidly scaled-up and markedly enhance care, particularly in rural areas of resource-constrained settings.