Broad One Health Endectocide-based Malaria Intervention in Africa (BOHEMIA)

Summary

The BOHEMIA program consists of a combination of studies organized around a central community prevention mass drug administration protocol and four sub-studies (i.e.; social science, entomology, health economics, and environmental), each written as an individual protocol. The protocol is central but used in two separate, individually powered trials in Mozambique and Kenya. The trials have been powered on the efficacy outcome and designed to meet the requirements of World Health Organization's (WHO) preferred product characteristics (PPC) for endectocides.

Timeline

Start

2022-03-17

Primary completion

2024-04-15

Completion

2024-10-03

Outcome

Mixed primary results

paper the adjusted incidence rate ratio (ivermectin vs. albendazole) was 0.74 (95% confidence interval [CI], 0.58 to 0.95, P = 0.02). PMID 40700688 ↗

paper the malaria infection incidence was comparable between all three arms with adjusted incidence rate ratio values of 0.99 (95% CI, 0.86-1.14, P > 0.9) PMID 41278243 ↗

Publications

• Chaccour C, Nicolas P, Martinho S, Mundaca H, Elobolobo E, Ruiz-Castillo P, Houana A, Montana J, Mbanze J, Casellas A, Macucha A, Mael M, Soares A, Kiuru C, Gutierrez AS, Imputiua S, Constantino L, Vegove V, Cole G, Duthaler U, Ribes M, Mutepa V, Brew J, Munguambe H, Stanulovic S, Xerinda A, Materula F, Gorski N, Wanjiku C, Furnival-Adams J, Tunez L, Sam L, Collins L, Xia K, Hammann F, Rudd M, Rist C, Jones C, Maia M, Candrinho B, Rabinovich NR, Saute F. Ivermectin to reduce malaria transmission- safety and efficacy results from the BOHEMIA cluster randomized trial in Mozambique. EClinicalMedicine. 2025 Nov 7;90:103632. doi: 10.1016/j.eclinm.2025.103632. eCollection 2025 Dec.
• Furnival-Adams J, Houana A, Saute F, Elobolobo E, Rudd M, Nicolas P, Montana J, Martinho S, Mundaca H, Mbanze J, Soares A, Imputiua S, Ruiz-Castillo P, Ribes M, Sanz A, Mamudo Sale M, Macucha A, Casellas A, Lopez V, Vegove V, Mutepa V, Munguambe H, Xerinda A, Materula F, Rabinovich NR, Engelman D, Chaccour C. Direct and indirect protection against scabies through ivermectin mass drug administration designed for malaria in Mozambique: a substudy nested within a cluster-randomised, controlled trial. Lancet Microbe. 2025 Dec;6(12):101189. doi: 10.1016/j.lanmic.2025.101189. Epub 2025 Nov 20.
• Chaccour C, Maia M, Kariuki M, Ruiz-Castillo P, Wanjiku C, Kasiwa L, Brazeal A, Casellas A, Ngama M, Onyango T, Elobolobo E, Kazungu K, Mael M, Wangari W, Nuru K, Otuko R, Sanz A, Ringera I, Matano A, Mitora S, Ribes M, Brew J, Gorski N, Nicolas P, Stanulovic S, Omondi I, Furnival-Adams J, Tunez L, Mbarak J, Vegove V, Yaa E, Mramba S, Kibet Y, Nyambura N, Rotich C, Wanjiru S, Vura M, Wanjiku F, Sam L, Collins L, Xia K, Hammann F, Saute F, Rudd M, Rist C, Jones C, Mwangangi J, Rabinovich NR. Ivermectin to Control Malaria - A Cluster-Randomized Trial. N Engl J Med. 2025 Jul 24;393(4):362-375. doi: 10.1056/NEJMoa2411262.
• Furnival-Adams J, Houana A, Nicolas P, Montana J, Martinho S, Casellas A, Mundaca H, Mbanze J, Soares A, Imputiua S, Ruiz-Castillo P, Ribes M, Sanz A, Sale MM, Macucha A, Elobolobo E, Vegove V, Mutepa V, Munguambe H, Xerinda A, Materula F, Rabinovich R, Saute F, Chaccour C. Collateral benefits of ivermectin mass drug administration designed for malaria against headlice in Mopeia, Mozambique: a cluster randomised controlled trial. Infect Dis Poverty. 2025 Mar 27;14(1):25. doi: 10.1186/s40249-025-01290-z.
• Ruiz-Castillo P, Imputiua S, Xie K, Elobolobo E, Nicolas P, Montana J, Jamisse E, Munguambe H, Materrula F, Casellas A, Deng X, Marathe A, Rabinovich R, Saute F, Chaccour C, Sacoor C. BOHEMIA a cluster randomized trial to assess the impact of an endectocide-based one health approach to malaria in Mozambique: baseline demographics and key malaria indicators. Malar J. 2023 Jun 4;22(1):172. doi: 10.1186/s12936-023-04605-3.
• Chaccour C, Casellas A, Hammann F, Ruiz-Castillo P, Nicolas P, Montana J, Mael M, Selvaraj P, Duthaler U, Mrema S, Kakolwa M, Lyimo I, Okumu F, Marathe A, Schurch R, Elobolobo E, Sacoor C, Saute F, Xia K, Jones C, Rist C, Maia M, Rabinovich NR. BOHEMIA: Broad One Health Endectocide-based Malaria Intervention in Africa-a phase III cluster-randomized, open-label, clinical trial to study the safety and efficacy of ivermectin mass drug administration to reduce malaria transmission in two African settings. Trials. 2023 Feb 21;24(1):128. doi: 10.1186/s13063-023-07098-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Albendazole	Small molecule	400 mg	Oral
Subject	Ivermectin	Small molecule	200 ug/kg	Oral
Subject	Ivermectin	Small molecule	400 ug/kg	Oral

Indications