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

NCT06516042 | Active Not Recruiting Phase 3

• 1 other identifier: RES-00764
• Study Type: interventional
• Target: 10,350
• Locations: 1 country
• Sites: 1

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

Conditions

Plasmodium Falciparum; Malaria

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Pf parasite prevalence in a subset of migrant farmworkers

  Up to 2 months

• Safety and tolerability of TDA

  Up to 6 months

• Feasibility of enhanced case management through mobile clinics based on cost per case detected

  Up to 6 months

• Feasibility and acceptability of enhanced case management through mobile clinics based on endline survey responses

  Up to 6 months

• Feasibility and acceptability of enhanced case management through mobile clinics based on qualitative interview data

  Up to 6 months

Study Arms (3)

Intervention with 2 TDA rounds

ACTIVE COMPARATOR

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

Intervention with 3 TDA rounds

ACTIVE COMPARATOR

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

Control (no TDA)

NO INTERVENTION

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

Interventions

Dihydroartemisinin-piperaquine 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.

Also known as: Piperaquine/dihydroartemisinin

Intervention with 2 TDA rounds; Intervention with 3 TDA rounds

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• PATH: lead
• Federal Minstry of Health of Ethiopia: collaborator

Study Sites (1)

Delello Farm Sites

Gonder, Metema District, Ethiopia

Location

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Interventions

piperaquine; artenimol

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 23, 2024
• Study Start: August 21, 2024
• Primary Completion: January 24, 2025
• Study Completion: July 1, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)