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| Name | Class |
|---|---|
| Federal Minstry of Health of Ethiopia | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention with 2 TDA rounds | Active Comparator | TDA with DP will be administered two times with a 4 - 6 week interval between rounds to all workers in the selected farm sites |
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| Intervention with 3 TDA rounds | Active Comparator | TDA with DP will be administered three times with a 4 - 6 week interval between rounds to all workers in the selected farm sites |
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| Control (no TDA) | No Intervention | TDA with DP will not be administered to any workers in the selected farm sites |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dihydroartemisinin-piperaquine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasmodium falciparum (Pf) parasite prevalence | Prevalence of Pf as determined by PCR at the end of the study | 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 | 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 | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 2 months |
| Safety and tolerability of TDA |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Bennett, PhD | PATH | Principal Investigator |
| Henry Ntuku, MD, PhD | PATH | Principal Investigator |
| Gudissa Assefa Bayissa | Ethiopia Federal Ministry of Health | Principal Investigator |
| Hiwot Teka | President's Malaria Initiative | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delello Farm Sites | Gonder | Metema District | Ethiopia |
For all data collected as part of the study, participants will be assigned a unique identification number. Individual identifiers (names, cell phone number) will be collected to support any follow up if needed. However, no personal identification information will be used in any reports arising out of this research.
Dried blood spots (DBS) will be collected from participants and shared with the Armauer Hansen Research Institute for sample analysis and storage. Stored biospecimens will be deidentified with no possibility of linking with study participants. Only a unique sample identification code will identify the samples. Results might be linked to the associated epidemiological data collected during the surveys from the participants, which will not include any identifiable information.
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| C034759 | piperaquine |
| C039060 | artenimol |
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Safety and tolerability of TDA measured through the incidence of adverse events and survey responses
| 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 | Up to 6 months |
| Feasibility and acceptability of enhanced case management through mobile clinics based on endline survey responses | Feasibility and acceptability of providing enhanced case management among the study team based on endline survey responses | Up to 6 months |
| Feasibility and acceptability of enhanced case management through mobile clinics based on qualitative interview data | Feasibility and acceptability of enhanced case management through mobile clinics based on information shared during qualitative interviews | Up to 6 months |
| D000079426 |
| Vector Borne Diseases |