Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
Impact of Point-of-Care Birth Test-and-Treat on Clinical Outcomes Among Infants With HIV: A Cluster-Randomized Trial in Mozambique and Tanzania.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04032522 (Neonatal HIV Early Infant Diagnosis), which is not on this map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID - Long Term Impact on inFant hEalth: a Feasibility Study of point-of Care Testing at Birth Versus at 6 Weeks of Age, on the Uptake of ART and Infant Prophylaxis, and on Rates of Infant Survival, Morbidity and Retention in Care
Who cites it
3 citing papers in PubMed.
- Point-of-care early infant HIV diagnosis at birth in a pragmatic cluster-randomized trial in Mozambique and Tanzania: A comparative cost and cost-effectiveness study.PLoS medicine · 2026Trial
- Impact of point-of-care maternal viral load testing at delivery on vertical HIV transmission risk assessment and neonatal prophylaxis: a cluster randomized trial.Journal of the International AIDS Society · 2025Trial
- Closing Diagnostic Gaps in Pediatric HIV: Innovations in Point-of-Care and Digital Monitoring with an Asia-Pacific Implementation Lens-A Systematic Review.Diagnostics (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe 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.
methodsThis 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.
resultsAmong 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.
conclusionsPoC 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. Clinical Trials Registration. NCT04032522.
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