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

NCT ID: NCT06516042

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 10350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-21
• Study Completion Date: 2025-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention with 2 TDA rounds

TDA with DP will be administered two times with a 4 - 6 week interval between rounds to all workers in the selected farm sites

Group Type: ACTIVE_COMPARATOR

Dihydroartemisinin-piperaquine

Intervention Type: DRUG

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.

Intervention with 3 TDA rounds

TDA with DP will be administered three times with a 4 - 6 week interval between rounds to all workers in the selected farm sites

Group Type: ACTIVE_COMPARATOR

Dihydroartemisinin-piperaquine

Intervention Type: DRUG

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.

Control (no TDA)

TDA with DP will not be administered to any workers in the selected farm sites

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Piperaquine/dihydroartemisinin

Eligibility Criteria

Inclusion Criteria

• At the time of the study, be a seasonal farm worker at one of the selected farm sites in Metema district
• Available and willingness to participate in the study and provide consent (or parental/guardian consent and asset in the case of minors)

Exclusion Criteria

• Severe illness (will be referred for care)
• Inability to provide informed consent
• Age 14-17 years old and not having a parent/guardian at the farm who can provide consent
• Age <14 years old

• Having received an antimalarial drug within the last 2 weeks
• Having any of the contraindications to receiving DP:

• History of cardiac rhythm disturbances, bradycardia, or heart failure
• Concomitant treatment with drugs that prolong the QT interval (fluconazole, fluoroquinolones, hydroxyzine, macrolides, ondansetron, etc.) or drugs containing any of the following: flecainide, metoprolol, imipramine, amitriptyline, clomipramine
• Known allergic reactions to DP or other artemisinin derivatives
• Pregnancy

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal Minstry of Health of Ethiopia

OTHER_GOV

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Bennett, PhD

Role: PRINCIPAL_INVESTIGATOR

PATH

Henry Ntuku, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

PATH

Gudissa Assefa Bayissa

Role: PRINCIPAL_INVESTIGATOR

Ethiopia Federal Ministry of Health

Hiwot Teka

Role: PRINCIPAL_INVESTIGATOR

President's Malaria Initiative

Locations

Delello Farm Sites

Gonder, Metema District, Ethiopia

Countries

Ethiopia

Other Identifiers

RES-00764

Identifier Type: -

Identifier Source: org_study_id