Despite WHO recommendations for early infant virologic diagnostic testing (EID) of HIV-exposed infants (HEI), in 2017, only 50% of HEI in 21 high-priority countries received an EID test in the first 2 months of life. This study builds on a Unitaid-funded, 9-country point-of-care (POC) EID implementation project that sought to improve access to EID and reduce turnaround time from sample collection to results availability.
This randomized stepped-wedge trial evaluated the effect of POC EID compared to standard-of-care conventional central lab-based testing on timely receipt of results in HEI. The study was conducted over two years, in two countries, Kenya and Zimbabwe. In each country, 18 health facilities were randomly selected from the list of project sites to serve as study sites. Study sites were randomized to one of four time points to transition from conventional EID testing to POC EID testing. HIV-exposed infants were eligible for inclusion if they presented for EID testing at the 4-8 week time-point recommended by the WHO. The study was powered to detect at least a 50% increase in the proportion of caregivers receiving HIV test results by 12 weeks of infant age after introduction of POC, assuming a design effect of 2.
In Zimbabwe, caregivers with infants tested under POC EID were 4.56 (95% CI: 4.5, 4.6) times more likely to receive the infant HIV test results by 12 weeks of age compared to conventional EID. In Kenya, caregivers with infants tested under POC EID were 1.29 (95% CI: 1.27, 1.3) times more likely to receive the infant HIV test results within 12 weeks of age compared to conventional EID. POC EID significantly reduced the turn-around-time between sample collection and return of infant HIV test results to caregiver by an average of 8.41 weeks (95% CI: 8.87, 7.95) in Zimbabwe and 3.29 weeks (95% CI: 3.55, 3.03). For HIV-infected infants, POC EID significantly reduced the time between sample collection and infant antiretroviral therapy (ART) initiation by an average of 7.97 weeks (95% CI: 3.62, 12.32) in Zimbabwe and 2.43 weeks (95% CI: 1.34 , 3.52) in Kenya.
POC EID improved return of results by 12 weeks of age, turnaround time to receipt of results, as well as rapid initiation on ART for infected infants. Even where conventional lab-based EID systems had been strengthened, as in Kenya, POC EID had significant benefit in providing results to caregivers quickly.