Globally an estimated 35% of HIV-positive infants are on antiretroviral therapy (ART), while only approximately 50% of HIV-exposed infants under 2 months of age received early infant diagnosis (EID) results in 2015. Novel point-of-care (POC) assays may increase access to EID and positively impact clinical care. We measured the effect of POC EID on ART initiation rates in infants and retention along the cascade of care.
We conducted a prospective cluster-randomized trial at 16 primary health care clinics (PHC) in Mozambique. Eight intervention PHCs implemented the Alere q HIV-1/2 Detect POC EID test conducted by nurses using whole blood collected from infants at 4-6 weeks of age (POC arm). Eight control PHCs collected dried blood spot specimens for EID testing at standard of care (SOC arm) reference laboratories. The primary outcome was the proportion of infants initiating ART within 60 days of specimen collection. Statistical analyses used a Generalized Estimating Equations model and Kaplan-Meier curves with log-rank test.
Significantly more infants in the POC arm (99.5%) received EID results within 60 days of specimen collection, compared to those in the SOC arm (11.8%; adjusted RR 9.50; p<0.001), with a median (IQR) time between sample collection and results receipt of 0 (0-0) and 122 (74-178) days, respectively. Moreover, 87.4% of infants with a positive result in the POC arm started ART within 60 days of specimen collection, compared to 12.8% of infants in the SOC arm (adjusted RR 7.12; p<0.001), with a median (IQR) time between sample collection and ART initiation of 0 (0-1) and 116 (35-154) days, respectively (Figure 1). A higher proportion of HIV-positive infants were retained at three months post-ART initiation in the POC arm compared to the SOC arm (63.1% versus 45.7%; adjusted RR 1.37; p=0.033).
POC EID significantly improved infant retention between testing and ART initiation and enabled earlier and increased ART initiation compared to laboratory EID testing. Decentralization of EID using POC technologies may accelerate ART initiation in challenging environments and contribute to achieving global pediatric ART targets.