Piloting the Feasibility and Preliminary Impact of Adding Birth HIV Polymerase Chain Reaction Testing to the Early Infant Diagnosis Guidelines in Kenya

Abstract

Background: In Kenya, standard early infant diagnosis (EID) with polymerase chain reaction (PCR) testing at 6-week postnatal achieves early treatment initiation (<12 weeks) in <20% of HIV+ infants. Kenya’s new early infant diagnosis guidelines tentatively proposed adding PCR testing at birth, pending results from pilot studies. Methods: We piloted birth testing at 4 Kenyan hospitals between November 2017 and November 2018. Eligible HIV-exposed infants were offered both point-of-care and PCR HIV testing at birth (window 0 to <4 weeks) and 6 weeks (window 4–12 weeks). We report the: proportion of infants tested at birth, 6-week, and both birth and 6-week testing; median infant age at results; seropositivity and antiretroviral therapy initiation. Results: Final sample included 624 mother-infant pairs. Mean maternal age was 30.4 years, 73.2% enrolled during antenatal care and 89.9% had hospital deliveries. Among the 590 mother–infants pairs enrolled before 4 weeks postnatal, 452 (76.6%) completed birth testing before 4 weeks, with 360 (79.6%) testing within 2 weeks, and 178 (39.4%) before hospital discharge (0–2 days). Mothers were notified of birth PCR results at a median infant age of 5.4 weeks. Among all 624 enrolled infants, 575 (92.1%) were tested during the 6-week window; 417 (66.8%) received testing at both birth and 6-weeks; and 207 received incomplete testing (93.3% only 1 PCR and 6.7% no PCR). Four infants were diagnosed with HIV, and 3 infants were initiated on antiretroviral therapy early, before 12 weeks of age. Conclusions: Uptake of PCR testing at birth was high and a majority of infants received repeat testing at 6 weeks of age.

The Cascade of Care for Early Infant Diagnosis in Zimbabwe: Point of Care HIV Testing at Birth and 6–8 Weeks

“…A modeling study comparing various testing algorithms showed that testing at birth and 6 weeks maximized life expectancy for HEI, but only if more than 60% of infants who tested negative at birth were retained in care through follow-up testing. 35 The lower rate of return for 10-week testing in South Africa contrasts with other sites piloting routine birth testing of HEI. A recent feasibility study of routine POC birth testing for HEI in Eswatini showed comparable rates of 6-8-week testing after implementation of routine birth testing-91% of exposed infants were tested pre-intervention, compared with 96% post-intervention.…”

‘The baby will have the right beginning’: Infant caregiver and health worker views on point-of-care HIV birth testing across 10 sites in Zimbabwe

“…Challenges with stockouts, broken machines, expensive cartridges, and electrical blackouts remain persistent barriers to sustainable implementation. A study in Kenya comparing piloting POC machines against conventional lab-based processing found higher rates of missed testing opportunities, largely due to machine/stock outs and invalid results (27).…”

‘The baby will have the right beginning’: a qualitative study on mother and health worker views on point-of-care HIV birth testing across 10 sites in Zimbabwe

“…The conventional testing study in Eswatini found that return rates for the follow-up appointment dropped from 78 to 74% after the introduction of BT [ 23 ], but the POC birth testing study in Eswatini found a 91% return rate for infants at 6-8 weeks who tested negative at birth [ 12 ]. A POC birth testing study in Kenya also found that 92% returned at the six-week follow-up period [ 27 ]. Thus, it appears feasible to encourage and achieve high levels of follow up testing for those testing negative at birth, given proper guidance and information.…”

“…Challenges with stockouts, broken machines, expensive cartridges, and electrical blackouts remain persistent barriers to sustainable implementation. A study in Kenya comparing piloting POC machines against conventional lab-based processing found higher rates of missed testing opportunities, largely due to machine/stock outs and invalid results [ 27 ]. Thus, introducing new diagnostic options must be accompanied by standardized systems for forecasting and ordering supplies.…”