NCT06516042

Targeted Antimalarial Drug Administration for Seasonal Migrant Populations in Amhara Region, Ethiopia

Effectiveness, Feasibility, and Acceptability of Targeted Antimalarial Interventions for Seasonal Migrant Populations in Metema District, Amhara Region, Ethiopia

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,350 (estimated)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the effectiveness, feasibility, and acceptability of targeted drug administration for seasonal migrant populations in Metema District, Amhara Region, Ethiopia

Detailed description

A cluster randomized controlled trial will be used to evaluate the effectiveness, feasibility, and acceptability of targeted antimalarial drug administration (TDA) for seasonal migrant farmworkers in the Delello farm sites in Metema district, Amhara Region. Individual farm sites will be randomized 1:1:1 to either of two intervention options or control, where all farmworkers at intervention sites will receive either two or three rounds of dihydro artemisinin piperaquine over the primary farming season. All study farm-sites will receive enhanced case management conducted by mobile health teams throughout the study period. Cross-sectional surveys will be conducted in all arms at baseline and 4 to 6 weeks following the third round of TDA to assess the effectiveness of the intervention for reducing parasite prevalence.

Conditions

• Plasmodium Falciparum
• Malaria

Interventions

Type	Name	Description
DRUG	Dihydroartemisinin-piperaquine	Participants that provide consent to participate in the TDA and are deemed eligible for treatment will receive a course of dihydroartemisinin-piperaquine (DP) if male, and artemether-lumefantrine (AL) if female. They will take the first dose of the treatment under direct observed therapy, and will receive the rest of the tablets to take on their own for days two and three.

Timeline

• Start date: 2024-08-21
• Primary completion: 2025-01-24
• Completion: 2025-07-01
• First posted: 2024-07-23
• Last updated: 2025-05-06

Locations

1 site across 1 country: Ethiopia