Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in Kenya

Matthew R Sandbulte, Brad J Gautney, May Maloba, Catherine Wexler, Melinda Brown, Natabhona Mabachi, Kathy Goggin, Raphael Lwembe, Niaman Nazir, Thomas A Odeny, Sarah Finocchario-Kessler, Matthew R Sandbulte, Brad J Gautney, May Maloba, Catherine Wexler, Melinda Brown, Natabhona Mabachi, Kathy Goggin, Raphael Lwembe, Niaman Nazir, Thomas A Odeny, Sarah Finocchario-Kessler

Abstract

Background: Infant HIV diagnosis by HIV DNA polymerase chain reaction (PCR) testing at the standard 6 weeks of age is often late to mitigate the mortality peak that occurs in HIV positive infants' first 2-3 months of life. Kenya recently revised their early infant diagnosis (EID) guidelines to include HIV DNA PCR testing at birth (pilot only), 6 weeks, 6 months, and 12 months postnatal and a final 18-month antibody test. The World Health Organization (WHO) approved point-of-care (POC) diagnostic platforms for infant HIV testing in resource-limited countries that could simplify logistics and expedite infant diagnosis. Sustainable scale-up and optimal utility in Kenya and other high-prevalence countries depend on robust implementation studies in diverse clinical settings.

Methods: We will pilot the implementation of birth testing by HIV DNA PCR, as well as two POC testing systems (Xpert HIV-1 Qual [Xpert] and Alere q HIV-1/2 Detect [Alere q]), on specimens collected from Kenyan infants at birth (0 to 2 weeks) and 6 weeks (4 to < 24 weeks) postnatal. The formative phase will inform optimal implementation of birth testing and two POC testing technologies. Qualitative interviews with stakeholders (providers, parents of HIV-exposed infants, and community members) will assess attitudes, barriers, and recommendations to optimize implementation at their respective sites. A non-blinded pilot study at four Kenyan hospitals (n = 2 Xpert, n = 2 Alere q platforms) will evaluate infant HIV POC testing compared with standard of care HIV DNA PCR testing in both the birth and 6-week windows. Objectives of the pilot are to assess uptake, efficiency, quality, implementation variables, user experiences of birth testing with both POC testing systems or with HIV DNA PCR, and costs.

Discussion: This study will generate data on the clinical impact and feasibility of adding HIV testing at birth utilizing POC and traditional PCR HIV testing strategies in resource-limited settings. Data from this pilot will inform the optimal implementation of Kenya's birth testing guidelines and of POC testing systems for the improvement of EID outcomes.

Trial registration: ClinicalTrials.gov, NCT03435887. Registered 26 February 2018.

Keywords: Birth testing; Early infant diagnosis; HIV; Implementation; Point-of-care testing.

Conflict of interest statement

The study was approved by the Institutional Review Boards at the Kenya Medical Research Institute (protocol KEMRI/SERU/CVR/018/3390) and the University of Kansas Medical Center (protocol # 00140399). Signed written informed consent will be obtained from the participants in formative interviews and parents enrolling in the pilot study. Data collected for analysis purposes will be de-identified and will not contain personal information.Not applicable.The authors declare that they have no actual or potential competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Patient flow during evaluation of infant HIV testing strategies. The study will track engagement of enrolled mother-infant pairs in point-of-care (POC) and standard of care HIV DNA polymerase chain reaction (PCR) test technologies through the birth and 6-week testing windows

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