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Elsbernd, K.* ; Sabi, I.* ; Jani, I.V.* ; Mudenyanga, C.* ; Boniface, S.* ; Mahumane, A.* ; Lequechane, J.* ; Chale, F.* ; Meggi, B.* ; Pereira, K.* ; Edom, R.* ; Lwilla, A.F.* ; Buck, W.C.* ; Ntinyinya, N.E.* ; Hoelscher, M. ; Baernighausen, T.* ; Kroidl, A.* ; Kohler, S.*

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 Med. 23:e1005069 (2026)
Verlagsversion Forschungsdaten DOI PMC
Open Access Gold
Creative Commons Lizenzvertrag
BACKGROUND: Timely access to early infant diagnosis (EID) is crucial for newborns with HIV, as late diagnosis can delay lifesaving antiretroviral treatment (ART). We assessed the comparative cost and cost-effectiveness of integrating point-of-care EID at birth into routine care in primary healthcare settings. METHODS AND FINDINGS: This pre-specified secondary analysis was nested in the cluster-randomized LIFE study conducted at 28 primary healthcare facilities in Mozambique and Tanzania from October 2019 to September 2021. We estimated the health system cost of point-of-care birth plus 4-8-week HIV testing (very early infant diagnosis; VEID) compared to standard-of-care (SoC) testing at 4-8 weeks only, both with immediate ART initiation. We assessed the cost-effectiveness of VEID relative to SoC with respect to ART initiation within one week of life using Bayesian hierarchical models. As this is an intermediate outcome, incremental cost-effectiveness ratios (ICERs) cannot be directly compared to available life-year-based cost-effectiveness thresholds. To contextualize results, we derived the minimum life-years gained per early ART initiation required for VEID to meet standard thresholds in a break-even analysis. VEID was associated with a higher cost and resulted in earlier ART initiation than SoC in both countries. In Mozambique, VEID increased the proportion of infants initiating ART within one week of life by 90.0 (95% CrI [67.5, 98.5]) percentage points at an incremental cost of $2,632 (95% CrI [$2,249, $3,062]) per infant with HIV. In Tanzania, VEID increased early ART initiation by 59.9 (95% CrI [20.9, 89.5]) percentage points at an incremental cost of $6,263 (95% CrI [$5,394, $7,243]) per infant with HIV. The ICER was $2,924 and $10,458 in Mozambique and Tanzania, respectively and was sensitive to intrauterine transmission rate. These findings were limited by the lack of long-term health outcome data and reliance on an intermediate outcome. Based on the break-even analysis, we estimated that VEID would need to yield 6-32 life-years gained per additional early ART initiation to meet standard thresholds. CONCLUSIONS: Adding birth testing improved early ART initiation but was unlikely to be cost-effective relative to standard thresholds given current prices, vertical transmission rates, and knowledge of long-term health benefits. Cost-effectiveness could be achieved at current costs if early ART translates to substantial long-term health benefits or if targeted to infants at high risk of vertical transmission.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Schlagwörter Antiretroviral Therapy; Reservoirs; Infection; Mortality; Children; Impact
ISSN (print) / ISBN 1549-1277
e-ISSN 1549-1676
Zeitschrift PLoS Medicine
Quellenangaben Band: 23, Heft: 5, Seiten: , Artikelnummer: e1005069 Supplement: ,
Verlag Public Library of Science (PLoS)
Verlagsort 1160 Battery Street, Ste 100, San Francisco, Ca 94111 Usa
Begutachtungsstatus Peer reviewed
Institut(e) Research Unit Global Health (UGH)
Förderungen European and Developing Countries Clinical Trials Partnership
UNITAID
Deutsches Zentrum fr Infektionsforschung