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

NCT04966702 | Completed Phase 3

• 1 other identifier: BOHEMIA
• Study Type: interventional
• Target: 48,145
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Malaria

Keywords

ivermectin; malaria; vector control

Outcome Measures

Primary Outcomes (2)

• To determine the safety (in humans) and efficacy of ivermectin MDA, administered to humans, or humans and livestock simultaneously (only in Mozambique) for the prevention of malaria.

  Efficacy: The efficacy endpoint is primarily measured in children (under 5 years of age in Mozambique and 5-15 years old in Kenya) and safety is determined by anyone who receives the drug. Infection incidence in the most vulnerable age group (children under 5 years of age in Mozambique and 5-15 years in Kenya) for 6 months from the moment of the first MDA round in their community. Infection incidence has been chosen as primary endpoint based on the WHOs PPC for endectocides.

  6 months

• To determine the safety (in humans) and efficacy of ivermectin MDA, administered to humans, or humans and livestock simultaneously (only in Mozambique) for the prevention of malaria.

  Safety: The safety endpoint is determined by anyone who receives the drug. Rate of adverse events (AEs) and serious adverse events (SAEs) and difference between ivermectin and albendazole.

  6 months

Secondary Outcomes (16)

• To assess the efficacy of the intervention using complementary methods (efficacy).

  6 months

• To assess the efficacy of the intervention using complementary methods (efficacy).

  6 months

• To assess the efficacy of the intervention using complementary methods (efficacy).

  6 months

• To assess the efficacy of the intervention using complementary methods (efficacy).

  6 months

• To assess the efficacy of the intervention using complementary methods (efficacy).

  6 months

Other Outcomes (4)

• To assess the relationship between self-reported pregnancy status, last menstrual period (LMP), and the results of pregnancy tests in women of reproductive age participating in the study.

  3 months

• To assess all-cause and malaria-related mortality in intervention and control arms (Mozambique only).

  18 months

• To assess all-cause and malaria-related mortality in intervention and control arms (Mozambique only).

  18 months

Study Arms (3)

Albendazole

ACTIVE COMPARATOR

The albendazole group will receive a single dose of 400 mg, given once a month for three months. Generic products will be used in both countries, the final product will be GMP certified and fully bioequivalent with GSK's Albenza®. Bendex (CIPLA) in Mozambique and G-Abzole (Guilin) in Kenya.

Drug: Albendazole Pill

Ivermectin human

EXPERIMENTAL

The ivermectin group will receive a single dose of 400 mcg/kg, given once a month for three months. Product to be used is Stromectol (Merck) in Mozambique and Ivermectin 3mg USP (Edenbridge) in Kenya.

Drug: Ivermectin Pill

Ivermectin human and livestock (Mozambique only)

EXPERIMENTAL

The ivermectin group will receive a single dose of 400 mcg/kg, given once a month for three months. Product to be used is Stromectol (Merck). For livestock, locally registered veterinary injectable ivermectin at 1% will be used.

Drug: Ivermectin Pill; Drug: Ivermectin Injectable Product

Interventions

Albendazole Pill DRUG

Using a MDA approach, fieldworkers will administer albendazole using directly observed treatment methodology to participants

Also known as: Alben, Bendex

Albendazole

Ivermectin Pill DRUG

Using a MDA approach, fieldworkers will administer ivermectin using directly observed treatment methodology to participants

Also known as: Stromectol

Ivermectin human; Ivermectin human and livestock (Mozambique only)

Ivermectin Injectable Product DRUG

Veterinary ivermectin injectable will be given to livestock in the relevant cluster

Also known as: Veterinary Ivermectin 1%

Ivermectin human and livestock (Mozambique only)

Eligibility Criteria

• Age: 1 Week - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For human treatment/safety cohort:
• Residents of the study area
• Male or female weighing more than 15kg
• Adult able to provide written consent
• Minors aged 12 to 17 able to provide assent
• Parent/guardian's able to provide consent for minors
• Negative pregnancy test for women aged between 13 and 49
• Agreement to adhere to study visits and procedures
• For pediatric active cohort:
• Children in the age of highest burden at the time of enrollment (under 5 years of age in Mozambique or 5-15 in Kenya)
• Residents of the study area
• Parent/guardian's able to provide consent for minors
• Minors aged 12 to 15 in Kenya able to provide assent
• For cross sectionals:
• Residents of the area for at least 3 months prior to enrolment

You may not qualify if:

• For human treatment/safety cohort:
• Known hypersensitivity to ivermectin or albendazole
• Risk of Loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria or Sudan
• Pregnant women
• Lactating women in the first week postpartum
• Children \< 15 kg
• Currently participating in another clinical trial
• Unwilling to provide informed consent or assent
• Unwilling to adhere to study visits and/or procedures
• Severely ill either self-reported or in the eyes of the investigator, e.g. defined as need for clinical care, or active or progressive disease interfering with activities of daily living. If in doubt, these criteria can be confirmed after a call with either the site PI/MD/safety officer against a pre-defined list.
• Currently under treatment with inhibitors of CYP3A or P-gp or other drugs that can interfere with the study
• For incidence cohort:
• Non-residents
• Currently enrolled in other clinical trial
• For cross sectionals:

Sponsors & Collaborators

• Barcelona Institute for Global Health: lead
• UNITAID: collaborator

Study Sites (2)

KEMRI

Kwale, 90100, Kenya

Location

CISM

Mopeia, Zambezia Province, Mozambique

Location

Related Publications (6)

• 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.

  PMID: 41278243 DERIVED

• 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.

  PMID: 41274299 DERIVED

• 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.

  PMID: 40700688 DERIVED

• 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.

  PMID: 40140904 DERIVED

• 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.

  PMID: 37271818 DERIVED

• 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.

  PMID: 36810194 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Albendazole; Ivermectin

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones

Study Officials

• Regina Rabinovich

  Barcelona Institute of Global Health

  PRINCIPAL INVESTIGATOR

• Carlos Chaccour

  Barcelona Institute of Global Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label, assessor-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The BOHEMIA trials are open-label with random assignment to one of 3 treatment arms in Mozambique and 2 in Kenya: (a) ivermectin in humans, (b) ivermectin in humans + livestock (only in Mozambique), or (c) albendazole control.

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: July 19, 2021
• Study Start: March 17, 2022
• Primary Completion: April 15, 2024
• Study Completion: October 3, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Protocol and ICF: upon ethical approval SAP: before finishing enrolment CSR and code: within 12 months of completion of the trial
• Access Criteria: TBD, Free-to-access, publicly available, searchable institutional website

Locations

KE (1); MO (1)