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

PATH

Status and phase: Active, not recruiting; Phase 3

Conditions: Plasmodium Falciparum; Malaria

Treatments: Drug: Dihydroartemisinin-piperaquine

Study type: Interventional

Funder types: Other

Identifiers

NCT06516042

RES-00764

Details and patient eligibility

About

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

Full 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.

Enrollment: 10,350 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,350 participants in 3 patient groups

Intervention with 2 TDA rounds

Active Comparator group

Description:

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

Treatment:

Drug: Dihydroartemisinin-piperaquine

Intervention with 3 TDA rounds

Active Comparator group

Description:

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

Treatment:

Drug: Dihydroartemisinin-piperaquine

Control (no TDA)

No Intervention group

Description:

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