Delello Farm Sites
Gonder, Metema District, Ethiopia
NCT Number: NCT06516042
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
This study is active but is not currently recruiting participants.
Notify Me14 year and older
All sexes
Interventional
Phase 3
Gonder, Metema District, 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additional exclusion criteria for the intervention group:
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.
Other names: Piperaquine/dihydroartemisinin
Time frame: Up to 6 months
Prevalence of Pf as determined by PCR at the end of the study
Time frame: Up to 6 months
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 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 2 months
Pf parasite prevalence measured in a subset of migrant farmworkers upon return to their home village in the western highlands
Time frame: Up to 6 months
Safety and tolerability of TDA measured through the incidence of adverse events and survey responses
Time frame: Up to 6 months
A cost assessment of providing enhanced case management through mobile clinics
Time frame: Up to 6 months
Feasibility and acceptability of providing enhanced case management among the study team based on endline survey responses
Time frame: Up to 6 months
Feasibility and acceptability of enhanced case management through mobile clinics based on information shared during qualitative interviews
PATH
Other
Effectiveness, Feasibility, and Acceptability of Targeted Antimalarial Interventions for Seasonal Migrant Populations in Metema District, Amhara Region, Ethiopia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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