Journal Article Ahead of print
PubMed: 42090430 DOI: 10.1371/journal.pmed.1005069
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(5):e1005069
Authors: Kira Elsbernd, Issa Sabi, Ilesh V Jani, Chishamiso Mudenyanga, Siriel Boniface, Arlete Mahumane, Joaquim Lequechane, Falume Chale, Bindiya Meggi, Kassia Pereira, Raphael Edom, Anange F Lwilla, W Chris Buck, Nyanda Elias Ntinyinya, Michael Hoelscher, Till Baernighausen, Arne Kroidl, Stefan Kohler
Affiliations
- Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany. Institute for Medical Information Processing, Biometry, and Epidemiology, LMU Munich, Munich, Germany. German Center for Infection Research (DZIF), partner site Munich, Munich, Germany.
- National Institute for Medical Research, Mbeya, Tanzania.
- Instituto Nacional de Saúde, Maputo, Mozambique.
- Clinton Health Access Initiative, Maputo, Mozambique.
- David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, United States of America.
- Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany.
- German Center for Infection Research (DZIF), partner site Munich, Munich, Germany.
- Immunology, Infection and Pandemic Research, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Munich, Germany.
- Unit Global Health, Helmholtz Center Munich, German Research Center for Environmental Health (HMGU), Neuherberg, Germany.
- Heidelberg Institute of Global Health, Faculty of Medicine and University Hospital, Heidelberg University, Heidelberg, Germany.
- German Center for Infection Research (DZIF), partner site Heidelberg, Heidelberg, Germany‌‌.
- Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Abstract
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.
MeSH
Research Design, Parturition, Point-Of-Care Systems, Infectious Disease Transmission, Vertical, Respect, Hiv, Diagnosis, Infant