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Last Updated: 20/12/2024

Attractive Targeted Sugar Bait Phase III Trial in Zambia

Objectives

The trial will evaluate the efficacy of ATSB deployment plus universal coverage of WHO core vector control (VC) interventions over two transmission seasons on a minimum 30% reduction in cohort clinical disease incidence, confirmed case incidence, and parasite prevalence, as compared with VC alone. Measurement of entomological outcomes, assessment of acceptability and barriers to uptake and consistent use of ATSB, safety and adverse event monitoring and estimation of the cost and cost-effectiveness of ATSB will also occur.

An open-label two-arm cluster randomized controlled trial (CRCT) design will be used comparing ATSB + LLINS vs LLINS alone (standard of care). A cluster trial design is indicated given the intended community-level effect of ATSBs on malaria transmission. Universal LLIN coverage will be ensured in both arms prior to start of the study and will serve as the standard of care. Arm 1 will receive ATSBs for two years. Arm 2 will receive the standard of care of universal LLIN coverage.

Principal Institution

PATH, United States

Study Design
ClinicalTrials.gov Identifier: NCT04800055
 
Study Type: Interventional
Study Phase: Not Applicable
Allocation: Randomized
Interventional Model: Parallel Assignment
Interventional Model Description: An open-label two-arm cluster randomized controlled trial (CRCT) design will be used comparing ATSB + universal coverage with a WHO core vector control intervention vs universal coverage with VC alone (standard of care). Universal VC (mainly LLIN) will be ensured in both arms prior to start of the study and will serve as the standard of care. Arm 1 will receive ATSBs for up to two years. Arm 2 will receive the standard of care of universal vector control coverage.
Masking: None (Open Label)
Primary Purpose: Prevention
 
Date

Dec 2020 — Dec 2023

Project Site

Zambia

Parent Project

Product Development

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