Broad One Health Endectocide-based Malaria Intervention in Africa (BOHEMIA)
NCT04966702 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48145
Last updated 2025-03-14
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
Interventions
- DRUG
-
Albendazole Pill
Using a MDA approach, fieldworkers will administer albendazole using directly observed treatment methodology to participants
- DRUG
-
Ivermectin Pill
Using a MDA approach, fieldworkers will administer ivermectin using directly observed treatment methodology to participants
- DRUG
-
Ivermectin Injectable Product
Veterinary ivermectin injectable will be given to livestock in the relevant cluster
Sponsors & Collaborators
-
UNITAID
collaborator OTHER -
Barcelona Institute for Global Health
lead OTHER
Principal Investigators
-
Regina Rabinovich · Barcelona Institute of Global Health
-
Carlos Chaccour · Barcelona Institute of Global Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Week
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-03-17
- Primary Completion
- 2024-04-15
- Completion
- 2024-10-03
Countries
- Kenya
- Mozambique
Study Locations
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