Plasmodium FalciparumPhase 3NCT06516042
Targeted Antimalarial Drug Administration for Seasonal Migrant Populations in Amhara Region, Ethiopia
A Phase 3 study testing Dihydroartemisinin-piperaquine in people with Plasmodium Falciparum and Malaria, run by PATH at 1 site in Ethiopia.
Trial 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 Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum, Malaria
- What is being tested?
- Dihydroartemisinin-piperaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,350 participants
- Where
- 1 siteEthiopia
- Study dates
- 21 Aug 2024to Jul 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness, Feasibility, and Acceptability of Targeted Antimalarial Interventions for Seasonal Migrant Populations in Metema District, Amhara Region, Ethiopia
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
Read the 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.
- Conditions
- Plasmodium Falciparum, Malaria
- Being tested
- Dihydroartemisinin-piperaquine
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-piperaquineDrug
Also called Piperaquine/dihydroartemisinin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dihydroartemisinin-piperaquine |
| 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 Receives: Drug: Dihydroartemisinin-piperaquine |
| Control (no TDA) | No intervention | TDA with DP will not be administered to any workers in the selected farm sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmodium falciparum (Pf) parasite prevalence
Prevalence of Pf as determined by PCR at the end of the study
Measured: 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
Measured: 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
Measured: Up to 6 months
Secondary outcomes (5)
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
Measured: Up to 2 months
Safety and tolerability of TDA
Safety and tolerability of TDA measured through the incidence of adverse events and survey responses
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start21 Aug 2024
- Primary completion24 Jan 2025
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium FalciparumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Minstry of Health of Ethiopia
- Responsible party
- Sponsor
- Investigators
- Adam Bennett, PhD, Principal investigator, PATHHenry Ntuku, MD, PhD, Principal investigator, PATHGudissa Assefa Bayissa, Principal investigator, Ethiopia Federal Ministry of HealthHiwot Teka, Principal investigator, President's Malaria Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516042
- Sponsor's protocol ID
- RES-00764
- Status last verified
- May 2025
- First submitted
- 11 Jul 2024
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Feasibility, and Acceptability of Targeted Antimalarial Interventions for Seasonal Migrant Populations in Metema District, Amhara Region, Ethiopia
- ClinicalTrials.gov ID
- NCT06516042
- Acronym / sponsor ID
- RES-00764
- Conditions
- Plasmodium Falciparum, Malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,350 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Federal Minstry of Health of Ethiopia
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- Jul 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention with 2 TDA rounds | Active comparator | Drug: Dihydroartemisinin-piperaquineTDA 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 | Active comparator | Drug: Dihydroartemisinin-piperaquineTDA with DP will be administered three times with a 4 - 6 week interval between rounds to all workers in the selected farm sites |
| Control (no TDA) | No intervention | –TDA with DP will not be administered to any workers in the selected farm sites |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
- Having received an antimalarial drug within the last 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dihydroartemisinin-piperaquineAlso: Piperaquine/dihydroartemisininParticipants 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. | Drug | Intervention with 2 TDA rounds, Intervention with 3 TDA rounds |
Primary outcome
Plasmodium falciparum (Pf) parasite prevalence
Time frame: Up to 6 months
Prevalence of Pf as determined by PCR at the end of the study
Feasibility of TDA
Time frame: 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
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
5 secondary outcomes
Pf parasite prevalence in a subset of migrant farmworkers
Time frame: Up to 2 months
Safety and tolerability of TDA
Time frame: Up to 6 months
Feasibility of enhanced case management through mobile clinics based on cost per case detected
Time frame: Up to 6 months
Feasibility and acceptability of enhanced case management through mobile clinics based on endline survey responses
Time frame: Up to 6 months
Feasibility and acceptability of enhanced case management through mobile clinics based on qualitative interview data
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Bennett, PhD principal investigator
PATH
Henry Ntuku, MD, PhD principal investigator
PATH
Gudissa Assefa Bayissa principal investigator
Ethiopia Federal Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dihydroartemisinin-piperaquine in people with Plasmodium Falciparum and Malaria, run by PATH at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasmodium falciparum (Pf) parasite prevalence (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.