A Randomized Trial of Point-of-Care Early Infant HIV Diagnosis in Zambia.

Background Point-of-care (POC) early infant diagnosis (EID) provides same-day results and the potential for immediate initiation of antiretroviral therapy (ART). Methods We conducted a pragmatic trial at six public clinics in Zambia. HIV-exposed infants were individually randomized to either: (a) POC EID - on-site testing with the Alere q HIV-1/2 Detect or (b) enhanced standard of care (SOC) EID - off-site testing at a public laboratory. HIV-infected infants were referred for ART and followed for 12 months. Our primary outcome was defined as alive, in care, and virally suppressed at 12 months. Results Between March 2016 and November 2018, we randomized 4,000 HIV-exposed infants to POC (n=1,989) or SOC (n=2,011). All but two infants in the POC group received same-day results, while the median time to result in the SOC group was 27 (IQR: 22-30) days. Eighty-one (2%, 95% CI: 1.6-2.5%) infants were diagnosed with HIV. Although ART initiation was high, there were 15 (19%) deaths, 15 (19%) follow-up losses, and 31 (38%) virologic failures. By 12 months, only 20 of 81 (25%, 95% CI: 15-34%) HIV-infected infants were alive, in care, and virally suppressed: 13 (30%, 95% CI: 16-43%) infants in the POC group vs. 7 (19%, 95% CI: 6-32%) in the SOC group (RR: 1.56, 95% CI: 0.7-3.50). Conclusions POC EID eliminated diagnostic delays and accelerated ART initiation but did not translate into definitive improvement in 12-month outcomes. In settings where centralized EID is well functioning, POC EID is unlikely to improve pediatric HIV outcomes.