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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Malaria; Plasmodium Falciparum
• Intervention / Treatment: Drug: Dihydroartemisinin-piperaquine

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.

• Study Type: Interventional
• Enrollment (Estimated): 10350
• Phase: Phase 3

Contacts and Locations

Study Locations

• Ethiopia
  • Metema District
    • Gondar, Metema District, Ethiopia
      • Delello Farm Sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Additional exclusion criteria for the intervention group:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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.; Other Names: Piperaquine/dihydroartemisinin
Active Comparator: 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	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.; Other Names: Piperaquine/dihydroartemisinin
No Intervention: Control (no TDA); TDA with DP will not be administered to any workers in the selected farm sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasmodium falciparum (Pf) parasite prevalence	Prevalence of Pf as determined by PCR at the end of the study	Up to 6 months
Feasibility of TDA	Feasibility of TDA measured through intervention coverage (% of participants treated among the total farm population) and cost effectiveness	Up to 6 months
Acceptability of TDA amongst farmworkers, farm-site owners, and local health authorities	Acceptability of TDA amongst farmworkers, farm-site owners, and local health authorities measured through drug adherence (% of participants completing the drugs as prescribed, as reported in the endline survey), survey response (self-reported values provided during endline survey), and qualitative interview data	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pf parasite prevalence in a subset of migrant farmworkers	Pf parasite prevalence measured in a subset of migrant farmworkers upon return to their home village in the western highlands	Up to 2 months
Safety and tolerability of TDA	Safety and tolerability of TDA measured through the incidence of adverse events and survey responses	Up to 6 months
Feasibility of enhanced case management through mobile clinics based on cost per case detected	A cost assessment of providing enhanced case management through mobile clinics	Up to 6 months
Feasibility and acceptability of enhanced case management through mobile clinics based on endline survey responses	Feasibility and acceptability of providing enhanced case management among the study team based on endline survey responses	Up to 6 months
Feasibility and acceptability of enhanced case management through mobile clinics based on qualitative interview data	Feasibility and acceptability of enhanced case management through mobile clinics based on information shared during qualitative interviews	Up to 6 months

Collaborators and Investigators

• Sponsor: PATH
• Collaborators: Federal Minstry of Health of Ethiopia
• Investigators: Principal Investigator: Adam Bennett, PhD, PATH; Principal Investigator: Henry Ntuku, MD, PhD, PATH; Principal Investigator: Gudissa Assefa Bayissa, Ethiopia Federal Ministry of Health; Principal Investigator: Hiwot Teka, President's Malaria Initiative

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Actual): January 24, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; Protozoan Infections; Parasitic Diseases; Malaria; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Piperaquine; Artenimol; Artemisinins
• Other Study ID Numbers: RES-00764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

For all data collected as part of the study, participants will be assigned a unique identification number. Individual identifiers (names, cell phone number) will be collected to support any follow up if needed. However, no personal identification information will be used in any reports arising out of this research.

Dried blood spots (DBS) will be collected from participants and shared with the Armauer Hansen Research Institute for sample analysis and storage. Stored biospecimens will be deidentified with no possibility of linking with study participants. Only a unique sample identification code will identify the samples. Results might be linked to the associated epidemiological data collected during the surveys from the participants, which will not include any identifiable information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No