HIV Point of Care tests in Babies Study (BABY)

Operational evaluation of HIV Point of Care tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya, Tanzania

HIV in infants is mainly vertically transmitted by infected mothers and is associated with high mortality rates if no antiretroviral treatment is provided. Accurate HIV diagnosis in infants is only feasible by detection of HIV nucleic acid (HIV-RNA or -DNA) and therefore HIV early infant diagnostic (EID) screening is routinely performed at the age of 6 weeks from dried blood samples requiring specialized laboratory facilities and multiple step linkage procedures for result dissemination. In the present BABY study HIV point of care tests (POC) will be evaluated in infants born to HIV infected mothers to evaluate for the operational feasibility as well as specificity, sensitivity and predictive values to detect infant HIV at birth, weeks 1, 2, 3 and 6. The rationally is to implement infant HIV bed side tests at obstetric/maternity clinics providing immediate diagnostic test results and in consequence avoiding the need of specialized laboratory facilities as error prone linkage procedures. Furthermore, the possibility of infant HIV diagnosis as early as the time of birth opens the possibility for earlier infant antiretroviral treatment initiation resulting into a possible further reduction of HIV related infant mortality/morbidity.

 

Objective: The primary objective of this study is to validate the operational specificity, sensitivity and predictive values of the POC HIV tests to identify vertical HIV transmission in the newborn confirmed by standard of care HIV Early Infant Diagnostic (HEID) and plasma viral load until 6 weeks post-partum in a public health setting at obstetric clinics in Mbeya, Tanzania.

Methods: An  in-vitro diagnostic study in infants born to HIV infected mothers evaluating the operational feasibility of HIV point of care tests (Xpert HIV-1 Qual) for HIV early infant diagnosis in a public health setting at obstetric clinics in Mbeya, Tanzania with a follow up of 6 weeks after birth. Recruitment will be performed at 4 obstetric/maternity study sites in Mbeya over 12 months. The operational study duration will therefore be approximately 14 months. The HIV POC test will be validated against established qualitative and quantitative DBS EID diagnostic tests and plasma HIV-RNA tests.

Preliminary Findings / Results: Not yet available

Future plans: The study outcome will provide operational evidence whether the investigated POC tests can be used for very early infant HIV diagnosis and will therefore prepare the ground for further planned activities. This includes studies investigating an expected improvement of EID test result linkage to care and treatment and related benefits for HIV infant mortality/morbidity; studies in neonates on treatment efficacy, toxicity and pharmacokinetics. The study will furthermore implement research capacity in Mbeya related to PMTCT and early infant treatment.

 

Team: Issa Sabi, MD, MMed (Principal Investigator), Leonard Maboko, MD, MSc, PhD (Sub-investigator,) John France, MD, MMed (Sub-investigator), Mkunde Chachage, PhD (Laboratoty manager), Cornelia Luer (Laboratory Manager), Dickens Kowuor (Data Manager).

Sponsors:  Medical Centre of the University of Munich (LMU), Division of Infectious Diseases and Tropical Medicine

Partners: Medical Centre of the University of Munich (LMU), Cepheid (Pty) LTD, Mbeya Referral Hospital

Publications: Pending

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