Targeted Antimalarial Drug Administration for Seasonal Migrant Populations in Amhara Region, Ethiopia
- Conditions
- Plasmodium FalciparumMalaria
- Interventions
- Registration Number
- NCT06516042
- Lead Sponsor
- PATH
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10350
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention with 2 TDA rounds Dihydroartemisinin-piperaquine TDA with DP will be administered two times with a 4 - 6 week interval between rounds to all workers in the selected farm sites Intervention with 3 TDA rounds Dihydroartemisinin-piperaquine TDA with DP will be administered three times with a 4 - 6 week interval between rounds to all workers in the selected farm sites
- Primary Outcome Measures
Name Time Method Feasibility of TDA Up to 6 months Feasibility of TDA measured through intervention coverage (% of participants treated among the total farm population) and cost effectiveness
Plasmodium falciparum (Pf) parasite prevalence Up to 6 months Prevalence of Pf as determined by PCR at the end of the study
Acceptability of TDA amongst farmworkers, farm-site owners, and local health authorities Up to 6 months 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
- Secondary Outcome Measures
Name Time Method Feasibility and acceptability of enhanced case management through mobile clinics based on endline survey responses Up to 6 months Feasibility and acceptability of providing enhanced case management among the study team based on endline survey responses
Pf parasite prevalence in a subset of migrant farmworkers Up to 2 months Pf parasite prevalence measured in a subset of migrant farmworkers upon return to their home village in the western highlands
Feasibility of enhanced case management through mobile clinics based on cost per case detected Up to 6 months A cost assessment of providing enhanced case management through mobile clinics
Feasibility and acceptability of enhanced case management through mobile clinics based on qualitative interview data Up to 6 months Feasibility and acceptability of enhanced case management through mobile clinics based on information shared during qualitative interviews
Safety and tolerability of TDA Up to 6 months Safety and tolerability of TDA measured through the incidence of adverse events and survey responses
Trial Locations
- Locations (1)
Delello Farm Sites
🇪🇹Gondar, Metema District, Ethiopia