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

Phase 3Active Not RecruitingNCT06516042

PATH10,350 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

10,350

Conditions

Plasmodium Falciparum Malaria

Interventions

Dihydroartemisinin-piperaquineDRUG

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.

Eligibility

Sex: ALLMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Delello Farm Sites

Gonder, Metema District, Ethiopia

Outcomes

Primary Outcomes

Plasmodium falciparum (Pf) parasite prevalence

Prevalence of Pf as determined by PCR at the end of the study

Time frame: 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

Time frame: 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

Time frame: Up to 6 months

Secondary Outcomes

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

Time frame: Up to 2 months

Safety and tolerability of TDA

Safety and tolerability of TDA measured through the incidence of adverse events and survey responses

Time frame: 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

Time frame: Up to 6 months

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

Data from ClinicalTrials.gov

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