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Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot
Matthew R Sandbulte1, Brad J Gautney2, May Maloba3
11Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS USA.
Insights
Early infant diagnosis of HIV in Kenya is being improved by piloting HIV DNA PCR testing at birth using point-of-care (POC) systems. This aims to reduce infant mortality by enabling faster diagnosis and linkage to care.
Area of Science:
- Global Health
- Infectious Diseases
- Diagnostics
Background:
- Standard infant HIV diagnosis at 6 weeks is often too late to prevent early mortality in HIV-positive infants.
- Kenya's revised guidelines include HIV DNA PCR testing at birth, 6 weeks, 6 months, and 12 months, with an 18-month antibody test.
- World Health Organization-approved point-of-care (POC) diagnostic platforms offer potential for simplified logistics and expedited infant HIV diagnosis in resource-limited settings.
Purpose of the Study:
- To pilot the implementation of HIV DNA PCR testing at birth and evaluate two POC testing systems (Xpert HIV-1 Qual and Alere q HIV-1/2 Detect) in Kenyan infants.
- To assess the feasibility, clinical impact, and optimal implementation strategies for birth testing and POC technologies in diverse clinical settings.
- To inform the refinement of Kenya's early infant diagnosis (EID) guidelines and the scale-up of POC testing.
Main Methods:
- A pilot study involving HIV DNA PCR testing at birth (0-2 weeks) and 6 weeks (4-<24 weeks) in Kenyan infants.
- Evaluation of two POC testing systems (Xpert and Alere q) alongside standard HIV DNA PCR testing.
- Qualitative interviews with healthcare providers, parents, and community members to identify barriers and facilitators to implementation.
Main Results:
- The study will assess uptake, efficiency, quality, implementation variables, user experiences, and costs associated with birth testing and POC systems.
- Data will be generated on the clinical impact and feasibility of integrating HIV testing at birth using POC and traditional PCR methods.
- The pilot aims to provide evidence for the optimal implementation of Kenya's birth testing guidelines and POC testing systems.
Conclusions:
- This pilot study will provide crucial data on the effectiveness and practicality of early infant HIV testing strategies in resource-limited environments.
- Findings will guide the optimal implementation of Kenya's revised EID guidelines, focusing on birth testing and the use of POC technologies.
- The study aims to improve early infant diagnosis outcomes and reduce mortality associated with HIV in infants.
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.
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