Clinical trial NCT06516042: Targeted Antimalarial Drug Administration for Seasonal Migrant Populations in Amhara Region, Ethiopia
Official title: Effectiveness, Feasibility, and Acceptability of Targeted Antimalarial Interventions for Seasonal Migrant Populations in Metema District, Amhara Region, Ethiopia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Plasmodium Falciparum
Malaria
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Federal Minstry of Health of Ethiopia
First posted: 2024-07-23
Enrollment: 10350
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

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

Primary outcomes:
measure: Plasmodium falciparum (Pf) parasite prevalence
timeFrame: Up to 6 months
measure: Feasibility of TDA
timeFrame: Up to 6 months
measure: Acceptability of TDA amongst farmworkers, farm-site owners, and local health authorities
timeFrame: Up to 6 months
Secondary outcomes:
measure: Pf parasite prevalence in a subset of migrant farmworkers
timeFrame: Up to 2 months
measure: Safety and tolerability of TDA
timeFrame: Up to 6 months
measure: Feasibility of enhanced case management through mobile clinics based on cost per case detected
timeFrame: Up to 6 months
measure: Feasibility and acceptability of enhanced case management through mobile clinics based on endline survey responses
timeFrame: Up to 6 months
measure: Feasibility and acceptability of enhanced case management through mobile clinics based on qualitative interview data
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Gondar
country: Ethiopia
facility: Delello Farm Sites
state: Metema District
Study officials:
affiliation: PATH
name: Adam Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: PATH
name: Henry Ntuku, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ethiopia Federal Ministry of Health
name: Gudissa Assefa Bayissa
role: PRINCIPAL_INVESTIGATOR
affiliation: President's Malaria Initiative
name: Hiwot Teka
role: PRINCIPAL_INVESTIGATOR
References: