E.W. "Al" Thrasher
Status: Funded - Open
Evaluation of a novel HIV point-of-care test for early infant diagnosis at birth in rural Zambia
Catherine Sutcliffe, PhD, ScM
BACKGROUND: Recent evidence suggests that early treatment can prevent damage to the developing immune system and potentially result in long-term remission when initiated soon after birth, but identifying and treating HIV-infected children is challenging in sub-Saharan Africa due to the lack of affordable and accessible laboratory tests for early infant diagnosis, particularly in rural areas.
GAP: A point-of-care test for early infant diagnosis would greatly improve access to testing, linkage to care, and earlier treatment initiation. Researchers at the Northwestern Global Health Foundation have developed a promising candidate test that has only been evaluated among children receiving routine diagnostic services at 6 weeks and 6 months of age in sub-Saharan Africa. To understand the true utility of this new point-of-care test for allowing HIV-infected infants to initiate treatment early, the validity of the test soon after birth should also be evaluated.
HYPOTHESIS: The primary hypothesis is that the point-of-care test will be valid for diagnosing in utero HIV infection when administered soon after birth. The secondary hypothesis is that it will be feasible to implement the point-of-care test soon after birth in rural and urban healthcare settings.
METHODS: The study, conducted at three rural clinics in the catchment area of Macha Hospital, Choma District, and two urban clinics in Livingstone, will be a cross-sectional study within the first 48 hours of life among infants born to HIV-infected women. All infants will be tested with both an HIV DNA test and the new point-of-care test.
IMPACT: Information on the validity and feasibility of this new point-of-care test for HIV diagnosis soon after birth in rural and urban settings is necessary and would add to the evidence as to whether this test could be recommended for general use and what testing schedules may be feasible.
Neonatal, HIV, Global Health, Diagnosis, Human
Johns Hopkins Bloomberg School of Public Health
United States, Zambia