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Jani, I.V.* ; Sabi, I.* ; Elsbernd, K.* ; Meggi, B.* ; Mahumane, A.* ; Lwilla, A.F.* ; Pereira, K.* ; Boniface, S.* ; Edom, R.* ; Lequechane, J.* ; Chale, F.* ; Chiwerengo, N.* ; Ntinginya, N.E.* ; Mudenyanga, C.* ; Mueller, M.* ; Rauscher, M.* ; Hoelscher, M. ; Taveira, N.* ; Buck, W.C.* ; Kroidl, A.*

Impact of point-of-care birth test-and-treat on clinical outcomes among infants with HIV: A cluster randomized trial in Mozambique and Tanzania.

Clin. Infect. Dis., DOI: 10.1093/cid/ciae530 (2024)
Verlagsversion DOI PMC
Open Access Gold (Paid Option)
BACKGROUND: We assessed the impact of point-of-care (PoC) test-and-treat at birth on clinical outcomes and viral suppression among 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. FINDINGS: Among 6602 neonates enrolled October 2019-September 2021, 125 were diagnosed HIV-positive by week 12. In the intervention arm, 38/69 (55.1%) were diagnosed at birth with 35 initiating ART within two days. In the control arm, 27/56 (48.2%) were retrospectively detected HIV-positive at birth, of whom 6/56 (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%) versus 48 (85.7%); aIRR 0.857; 95% CI 0.505-1.492], but showed a 68% relative reduction in 6-month mortality. Viral suppression was poor overall, but improved in the intervention group at month 18 (65.7% versus 29.6%; p=0.005). INTERPRETATION: PoC test-and-treat at birth is feasible in resource-poor settings and resulted in clinically-relevant reduction of early infant mortality, though improved clinical outcomes were not sustained to month-18. Poor viral suppression may undermine early survival benefits, calling for better paediatric treatments and tailored adherence interventions.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Korrespondenzautor
Schlagwörter Hiv ; Birth Testing ; Early Infant Diagnosis ; Neonatal Treatment ; Point-of-care Testing ; Test-and-treat; Combination Antiretroviral Therapy; Early Initiation; Hiv Diagnosis; Mortality; Suppression; Infection; Assay; Age
ISSN (print) / ISBN 1058-4838
e-ISSN 1537-6591
Zeitschrift Clinical Infectious Diseases
Verlag Oxford University Press
Verlagsort Cary, NC
Nichtpatentliteratur Publikationen
Begutachtungsstatus Peer reviewed
Institut(e) Unit Global Health (UGH)
Förderungen German Center for Infection Research
Unitaid
European and Developing Countries Clinical Trials Partnership