Malaria, Plasmodium Falciparum
Conditions
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.
Interventions
DRUGDihydroartemisinin-piperaquine
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.
Sponsors
Federal Minstry of Health of Ethiopia
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasmodium falciparum (Pf) parasite prevalence | Up to 6 months | Prevalence of Pf as determined by PCR at the end of the study |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
Ethiopia
Outcome results
None listed