Impact of Point-of-Care Birth Test-and-Treat on Clinical Outcomes Among Infants With HIV: A Cluster-Randomized Trial in Mozambique and Tanzania

Background. We assessed the impact of point-of-care (PoC) test-and-treat at birth on clinical outcomes and viral suppression among human immunodeficiency virus (HIV)-positive infants in Mozambique and Tanzania. Methods. This cluster-randomized trial allocated health facilities to intervention, providing PoC testing and antiretroviral treatment (ART) at birth and week 4-8, or control, starting these at week 4-8. The primary outcome was proportions of clinical events (mortality, morbidity, retention, virological failure, toxicity) among HIV-positive infants at month 18. We estimated incidence rate ratios adjusted for timing of HIV detection (aIRR) and reported viral suppression <1000 copies/mL. Results. Among 6602 neonates enrolled during October 2019-September 2021, 125 were diagnosed with HIV by week 12. In the intervention arm, 38 of 69 (55.1%) were diagnosed at birth. In the control arm, 27 of 56 (48.2%) were retrospectively detected to be HIV-positive at birth, of whom 6 of 56 (10.7%) died or were lost to follow-up before testing. Median age at ART initiation was 6 (intervention) versus 33 days (control). Birth test-and-treat was not associated with a significant reduction in clinical outcomes up to month 18 (53 [76.8%] vs 48 [85.7%]; aIRR, 0.857 [95% confidence interval, .505-1.492]), but showed a 68% relative reduction in 6-month mortality. Viral suppression was poor overall. Conclusions. PoC test-and-treat at birth is feasible in resource-poor settings and resulted in clinically relevant reduction of early mortality, though improved clinical outcomes were not sustained to month 18. Poor viral suppression may undermine early benefits, calling for better pediatric treatments and adherence interventions.