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

2025-05Contributo em revista Acesso aberto
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datacite.subject.fosCiências Médicas::Ciências da Saúde
datacite.subject.sdg03:Saúde de Qualidade
dc.contributor.authorJani, Ilesh V.
dc.contributor.authorSabi, Issa
dc.contributor.authorElsbernd, Kira
dc.contributor.authorMeggi, Bindiya
dc.contributor.authorMahumane, Arlete
dc.contributor.authorLwilla, Anange Fred
dc.contributor.authorPereira, Kassia
dc.contributor.authorBoniface, Siriel
dc.contributor.authorEdom, Raphael
dc.contributor.authorLequechane, Joaquim
dc.contributor.authorChale, Falume
dc.contributor.authorChiwerengo, Nhamo
dc.contributor.authorNtinginya, Nyanda E.
dc.contributor.authorMudenyanga, Chishamiso
dc.contributor.authorMueller, Mariana
dc.contributor.authorRauscher, Martina
dc.contributor.authorHoelscher, Michael
dc.contributor.authorTaveira, Nuno
dc.contributor.authorBuck, W. Chris
dc.contributor.authorKroidl, Arne
dc.contributor.authorLIFE Study Consortium
dc.date.accessioned2026-05-12T10:30:03Z
dc.date.available2026-05-12T10:30:03Z
dc.date.issued2025-05
dc.description.abstractBackground: 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. Clinical Trials Registration. NCT04032522.eng
dc.identifier.citationIlesh V Jani, Issa Sabi, Kira Elsbernd, Bindiya Meggi, Arlete Mahumane, Anange Fred Lwilla, Kassia Pereira, Siriel Boniface, Raphael Edom, Joaquim Lequechane, Falume Chale, Nhamo Chiwerengo, Nyanda E Ntinginya, Chishamiso Mudenyanga, Mariana Mueller, Martina Rauscher, Michael Hoelscher, Nuno Taveira, W Chris Buck, Arne Kroidl, the LIFE Study Consortium, Impact of Point-of-Care Birth Test-and-Treat on Clinical Outcomes Among Infants With HIV: A Cluster-Randomized Trial in Mozambique and Tanzania, Clinical Infectious Diseases, Volume 80, Issue 5, 15 May 2025, Pages 1114–1124, https://doi.org/10.1093/cid/ciae530
dc.identifier.doi10.1093/cid/ciae530
dc.identifier.issn1537-6591
dc.identifier.urihttp://hdl.handle.net/10400.26/63071
dc.language.isoeng
dc.peerreviewedyes
dc.publisherOxford University Press
dc.relation.hasversionhttps://doi.org/10.1093/cid/ciae530
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectHIV
dc.subjectpoint-of-care testing
dc.subjectbirth testing
dc.subjecttest-and-treat
dc.subjectneonatal treatment
dc.titleImpact of point-of-care birth test-and-treat on clinical outcomes among infants with HIV : a cluster-randomized trial in Mozambique and Tanzaniaeng
dc.typecontribution to journal
dspace.entity.typePublication
oaire.citation.endPage1124
oaire.citation.issue5
oaire.citation.startPage1114
oaire.citation.titleClinical Infectious Diseases
oaire.citation.volume80
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85

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