Article Category:
Research Article

Costs, Coverage, and Acceptability of Azithromycin Mass Administration to Children 1–11 Versus 1–59 Months Old to Reduce Mortality: A Cluster-Randomized Trial in Niger

Ahmed M. Arzika Centre de Recherche et Interventions en Santé Publique, Birni N’Gaoure, Niger;

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Ramatou Maliki Centre de Recherche et Interventions en Santé Publique, Birni N’Gaoure, Niger;

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Abdou Amza Programme Nationale de Santé Oculaire, Niamey, Niger;

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Alio Karamba Centre de Recherche et Interventions en Santé Publique, Birni N’Gaoure, Niger;

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Nasser Gallo Centre de Recherche et Interventions en Santé Publique, Birni N’Gaoure, Niger;

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Bawa Aichatou Centre de Recherche et Interventions en Santé Publique, Birni N’Gaoure, Niger;

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Ismael I. Sara Centre de Recherche et Interventions en Santé Publique, Birni N’Gaoure, Niger;

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Diallo Beidi Centre de Recherche et Interventions en Santé Publique, Birni N’Gaoure, Niger;

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Laminou M. Haroun Centre de Recherche et Interventions en Santé Publique, Birni N’Gaoure, Niger;

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Farissatou Oumarou Centre de Recherche et Interventions en Santé Publique, Birni N’Gaoure, Niger;

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Carolyn Brandt Francis I. Proctor Foundation, University of California, San Francisco, California;

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Brittany Peterson Francis I. Proctor Foundation, University of California, San Francisco, California;

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Elodie Lebas Francis I. Proctor Foundation, University of California, San Francisco, California;

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Emily Colby Francis I. Proctor Foundation, University of California, San Francisco, California;

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William Nguyen Francis I. Proctor Foundation, University of California, San Francisco, California;

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Zijun Liu Francis I. Proctor Foundation, University of California, San Francisco, California;

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Benjamin F. Arnold Francis I. Proctor Foundation, University of California, San Francisco, California;
Department of Ophthalmology, University of California, San Francisco, California;
Institute for Global Health Sciences, University of California, San Francisco, California;

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Thomas M. Lietman Francis I. Proctor Foundation, University of California, San Francisco, California;
Department of Ophthalmology, University of California, San Francisco, California;
Institute for Global Health Sciences, University of California, San Francisco, California;
Department of Epidemiology and Biostatistics, University of California, San Francisco, California;

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Meagan C. Fitzpatrick Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland

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Kieran S. O’Brien Francis I. Proctor Foundation, University of California, San Francisco, California;
Department of Ophthalmology, University of California, San Francisco, California;
Institute for Global Health Sciences, University of California, San Francisco, California;
Department of Epidemiology and Biostatistics, University of California, San Francisco, California;

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on behalf of the AVENIR Study Group
DOI:
https://doi.org/10.4269/ajtmh.24-0723
Volume/Issue:
Ahead of Print
Open access
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Azithromycin mass drug administration (MDA) for 1- to 59-month-olds reduces child mortality. However, guidelines restrict eligibility to 1- to 11-month-olds because of concerns about antimicrobial resistance. This cluster-randomized implementation trial was conducted in parallel with a larger efficacy trial and compared implementation outcomes between these approaches. Rural communities in Niger were randomly assigned to receive biannual azithromycin MDA for either 1- to 59-month-olds or 1- to 11-month-olds over 1 year. The primary outcome was the community-level cost per dose delivered. Secondary outcomes included reach (coverage), as well as acceptability, appropriateness, and feasibility according to participants and providers. In November 2020, 40 eligible communities were randomly assigned to each arm, with 37 communities in the 1- to 59-month arm and 39 communities in the 1- to 11-month arm contributing to analyses. The mean cost per dose delivered was $6.50 lower (95% CI –$10.40 to –$3.70; P-value <0.001) in the 1- to 59-month arm ($1.60; 95% CI $1.00 to $2.30) compared with the 1- to 11-month arm ($8.20; 95% CI $7.60 to $8.80). Treatment coverage was similar by arm and exceeded 90% in both distributions. More caregivers in the 1- to 59-month arm found the intervention acceptable (mean difference 4.2%; 95% CI 0 to 8.4%; P-value 0.04) and appropriate (3.4%; 95% CI 0.1 to 6.8%; P-value 0.04) compared with the 1- to 11-month arm. When combining arms, all groups indicated that including 1- to 59-month-olds was more acceptable, appropriate, and feasible than restricting to 1- to 11-month-olds. No serious adverse events were reported. Overall, including 1- to 59-month-olds resulted in a lower cost per dose delivered than restricting to 1- to 11-month-olds. Community groups perceived both interventions to be acceptable, appropriate, and feasible, but they strongly preferred the 1- to 59-month treatment.

Author Notes

Financial support: This work was funded by Bill & Melinda Gates Foundation grants OPP1210548 and INV-002454. The funder reviewed and approved the study design but had no role in data collection, analysis, interpretation, the writing of the report, or the decision to submit the manuscript for publication.

Disclosure: Ethical approval was obtained from the Institutional Review Boards (IRB) at the Niger Ministry of Health (Comité Nationale Éthique pour la Recherche en Santé, N 041/2020/CNERS) and the University of California, San Francisco (19-28387). At the community level, verbal consent was obtained from community and health center leaders before the study started. At the individual level, informed consent was obtained from caregivers before study procedures were conducted. Written informed consent was obtained from caregivers for children aged 30–42 days, and verbal consent was obtained for children older than 42 days. The University of California, San Francisco IRB required written consent for the youngest age group because of concerns about the potential for macrolide-associated infantile hypertrophic pyloric stenosis.38 Age was verified using the child’s health card when available or via caregiver reports guided by a calendar of events. Consent conversations were conducted in local languages, including Zarma, Hausa, and Peul, by fluent study team members. A Data and Safety Monitoring Committee provided independent oversight and reviewed the study protocol, procedures, and participant safety in the concurrent effectiveness and implementation trials. The trial was conducted in accordance with the Declaration of Helsinki and was registered at clinicaltrials.gov (NCT04224987).

Authors’ contributions: A. M. Arzika, R. Maliki, E. Lebas, W. Nguyen, B. F. Arnold, T. M. Lietman, M. C. Fitzpatrick, and K. S. O’Brien contributed to the study conception and design. A. M. Arzika, R. Maliki, A. Amza, E. Lebas, B. Peterson, E. Colby, W. Nguyen, M. C. Fitzpatrick, and K. S. O’Brien provided oversight for study implementation. R. Maliki, K. Alio, N. Gallo, B. Aichatou, I. S. Sara, D. Beidi, L. M. Haroun, F. Oumarou, B. Peterson, C. Brandt, E. Colby, W. Nguyen, and Z. Liu contributed to study implementation. Z. Liu and B. F. Arnold contributed to randomization. B. Peterson and C. Brandt led data analysis. K. S. O’Brien wrote the first draft of the manuscript, and all authors contributed to its review and revision. B. Peterson, C. Brandt, and K. S. O’Brien have directly accessed and verified the data underlying the manuscript. All authors had full access to all study data and accept responsibility to submit this manuscript for publication.

Data availability: The de-identified dataset and data dictionary will be publicly available at https://osf.io/7vu2p/ at the time of publication.

Current contact information: Ahmed M. Arzika, Ramatou Maliki, Alio Karamba, Nasser Gallo, Bawa Aichatou, Ismael I. Sara, Diallo Beidi, Laminou M. Haroun, and Farissatou Oumarou, Centre de Recherche et Interventions en Santé Publique, Birni N’Gaoure, Niger, Emails: ahmedarzika@gmail.com, maliki.ramatou@yahoo.fr, mankarambalio@gmail.com, nassermgalo@gmail.com, bawaaichatou2@gmail.com, ismaelmamanebello96@gmail.com, diallobeidi@gmail.com, hmamanlaminou@yahoo.com, and farissatououmarou29@gmail.com, Abdou Amza, Programme Nationale de Santé Oculaire, Ministere de la Sante Publique, Niamey, Niger, E-mail: dr.amzaabdou@gmail.com. Carolyn Brandt, Brittany Peterson, Elodie Lebas, Emily Colby, William Nguyen, Zijun Liu, Benjamin F. Arnold, Thomas M. Lietman, and Kieran S. O’Brien, Proctor Foundation, University of California, San Francisco, San Francisco, CA, E-mails: Carolyn.Brandt@ucsf.edu, Brittany.Peterson@ucsf.edu, Elodie.Lebas@ucsf.edu, emily.michele.colby@gmail.com, willsanguyener@gmail.com, zijunliu2015@gmail.com, Ben.Arnold@ucsf.edu, Tom.Lietman@ucsf.edu, and kieran.obrien@ucsf.edu. Meagan C. Fitzpatrick, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, E-mail: meagan.fitzpatrick@som.umaryland.edu.

Address correspondence to Kieran S. O’Brien, Francis I. Proctor Foundation, Departments of Ophthalmology and Epidemiology & Biostatistics, Institute for Global Health Sciences, University of California, San Francisco, 490 Illinois St., 2nd Floor, San Francisco, CA 94158. E-mail: kieran.obrien@ucsf.edu
Copyright:
© The author(s) 2025
Received:
29 Oct 2024
|
Accepted:
04 Jan 2025
|
Published Online:
08 Apr 2025
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
Online ISSN:
1476-1645
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