Malaria FalciparumPhase 4NCT06928207
Private Medicine Retailer-based Trial of Malaria Tests and Conditional Treatment Subsidies Among Patients With Fever
A Phase 4 study testing Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positive in people with Malaria Falciparum, run by Clinton Health Access Initiative Inc. at 1 site in Nigeria.
Trial summary
The goal of this study observational study is to test the effect of conditional subsidies for Rapid Diagnostic Tests (RDT) and Artemisinin Combination Therapies (ACT) on improving the management of malaria fevers that seek care in the retail sector. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Malaria Falciparum
- What is being tested?
- Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNigeria
- Study dates
- 31 Dec 2023to 31 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants who tested in the Private Medicine Retailer and/or purchased antimalarial (s) for themselves.
- Individuals with malaria-like illness must be present at recruitment.
- Older than one year of age.
Who cannot join
- Any individual with signs of severe illness requiring immediate referral.
- Individuals who have taken an antimalarial in the last seven days, including for the current illness.
- Patients <18 years without a parent or legal guardian present.
- Adults who are unable to consent for themselves
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Experiment of Malaria Diagnostic Testing and Conditional Treatment Subsidies to Increase the Proportion of Malaria Patients Receiving an ACT
The goal of this study observational study is to test the effect of conditional subsidies for Rapid Diagnostic Tests (RDT) and Artemisinin Combination Therapies (ACT) on improving the management of malaria fevers that seek care in the retail sector. The main question it aims to answer is:
- Would a conditional subsidy scheme increase the proportion of clients with malaria receiving an ACT? Researchers will compare the proportion of patients with malaria receiving an ACT in the intervention arms to the control arm. Retail providers in the intervention arm have access to free RDTs and subsidized ACTs distributed by the research team and are asked to use a recommended retail price for the RDT and ACT. In addition, the providers in the intervention arm are trained in the use of RDTs and a mobile app that will prompt them to take and upload a picture of the RDT result. Retail providers in the control arm are trained in the use of RDTs but do not receive free RDTs or subsidized ACTs.
Read the detailed description
The ultimate goal of the conditional subsidy scheme is to increase the proportion of patients with malaria that receives an artemisinin combination therapy (ACT) at the point of sale.
The objective of this study is to test the effect of providing low-cost malaria rapid diagnostic tests (RDT) and Artemisinin Combination Therapies (ACTs) to patients on improving the management of malaria fevers that receive care in private medicine retailers (PMR). During the study, malaria RDTs are provided free of charge to the private provider to conduct malaria-RDT testing at a low cost (at a set recommended retail price) for patients with a malaria-like illness. Subsidized ACTs are provided to the provider, conditional on the provider conducting the malaria RDT and selling the ACT at a low cost to patients testing positive for malaria. Outcomes will be measured by exit interviews on random days each month at participating PMRs.
- Conditions
- Malaria Falciparum
- Being tested
- Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positive
- Keywords
- Malaria, Private sector, Private Medicine Retailers, Drug shops, Subsidies, Case management, RDT, ACT, Nigeria
- 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.
Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positiveCombination product
To promote the use of the recommended first line drug, we implement a conditional subsidy. The retail provider is given the malaria diagnostic for free and is instructed to test clients suspected of having malaria. Only if the test is positive, the provider is instructed to provide the ACT at a low cost.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Free RDTs and conditional ACT subsidy: Patients visiting PMRs in this arm will receive a low-cost ACT if they use a low-cost RDT and have a positive test result. Receives: Combination Product: Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positive |
| Control | No intervention | Control: Standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACT uptake among patients testing positive for malaria during the exit interview
The proportion of patients with malaria that purchased an ACT during their visit to the PMR. For this outcome, a patient with malaria is anyone who has a malaria RDT performed and tests positive at the exit interview.
Measured: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)
Secondary outcomes (3)
Case management of patients visiting the PMR suspected of having malaria
The proportion of patients suspected of malaria cases that are managed appropriately (tested for malaria in the PMR or elsewhere but with proof and purchase any ACT following a positive RDT test result or do not purchase an ACT after a negative RDT rest result)
Measured: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approximately 30 min)]
Out of pocket expenses incurred by patients suspected of having malaria
The out-of-pocket expenses incurred in the PMR by patients suspected of having malaria for ACTs and RDTs
Measured: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approximately 30 min)]
Proportion of untested clients who purchase ACTs
Proportion of clients visiting the PMR that did not test in the drugshop and purchased ACTs
Measured: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start31 Dec 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Private medicine retailers are recruited through a readiness assessment survey. A total of 60 licensed PMRs (based on a list provided by Pharmacy council Nigeria and NAPPMED) in the two targeted LGAs will be randomly selected and visited by trained data collectors and asked to participate in a short survey. The purpose of the survey is to determine (i) whether they are registered and (ii) willingness to participate in the study. Following the readiness assessment, a random sample of 24 PMRs are selected from eligible PMRs. Out of these 20 PMRs will be randomly selected for inclusion in the study with the remaining 4 PMRs serving as backups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinton Health Access Initiative Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928207
- Sponsor's protocol ID
- NHREC/01/01/2007- 19/05/2023
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Experiment of Malaria Diagnostic Testing and Conditional Treatment Subsidies to Increase the Proportion of Malaria Patients Receiving an ACT
- ClinicalTrials.gov ID
- NCT06928207
- Acronym / sponsor ID
- NHREC/01/01/2007- 19/05/2023
- Conditions
- Malaria Falciparum
- Keywords
- Malaria, Private sector, Private Medicine Retailers, Drug shops, Subsidies, Case management, RDT, ACT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Clinton Health Access Initiative Inc.University, hospital or other
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 15 Apr 2025 (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 goal of this study observational study is to test the effect of conditional subsidies for Rapid Diagnostic Tests (RDT) and Artemisinin Combination Therapies (ACT) on improving the management of malaria fevers that seek care in the retail sector. The main question it aims to answer is:
- Would a conditional subsidy scheme increase the proportion of clients with malaria receiving an ACT? Researchers will compare the proportion of patients with malaria receiving an ACT in the intervention arms to the control arm. Retail providers in the intervention arm have access to free RDTs and subsidized ACTs distributed by the research team and are asked to use a recommended retail price for the RDT and ACT. In addition, the providers in the intervention arm are trained in the use of RDTs and a mobile app that will prompt them to take and upload a picture of the RDT result. Retail providers in the control arm are trained in the use of RDTs but do not receive free RDTs or subsidized ACTs.
Detailed description
The ultimate goal of the conditional subsidy scheme is to increase the proportion of patients with malaria that receives an artemisinin combination therapy (ACT) at the point of sale.
The objective of this study is to test the effect of providing low-cost malaria rapid diagnostic tests (RDT) and Artemisinin Combination Therapies (ACTs) to patients on improving the management of malaria fevers that receive care in private medicine retailers (PMR). During the study, malaria RDTs are provided free of charge to the private provider to conduct malaria-RDT testing at a low cost (at a set recommended retail price) for patients with a malaria-like illness. Subsidized ACTs are provided to the provider, conditional on the provider conducting the malaria RDT and selling the ACT at a low cost to patients testing positive for malaria. Outcomes will be measured by exit interviews on random days each month at participating PMRs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Private medicine retailers are recruited through a readiness assessment survey. A total of 60 licensed PMRs (based on a list provided by Pharmacy council Nigeria and NAPPMED) in the two targeted LGAs will be randomly selected and visited by trained data collectors and asked to participate in a short survey. The purpose of the survey is to determine (i) whether they are registered and (ii) willingness to participate in the study. Following the readiness assessment, a random sample of 24 PMRs are selected from eligible PMRs. Out of these 20 PMRs will be randomly selected for inclusion in the study with the remaining 4 PMRs serving as backups.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Combination Product: Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positiveFree RDTs and conditional ACT subsidy: Patients visiting PMRs in this arm will receive a low-cost ACT if they use a low-cost RDT and have a positive test result. |
| Control | No intervention | –Control: Standard practice |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who tested in the Private Medicine Retailer and/or purchased antimalarial (s) for themselves.
- Individuals with malaria-like illness must be present at recruitment.
- Older than one year of age.
Key exclusion criteria (4 listed)
- Any individual with signs of severe illness requiring immediate referral.
- Individuals who have taken an antimalarial in the last seven days, including for the current illness.
- Patients <18 years without a parent or legal guardian present.
- Adults who are unable to consent for themselves
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 |
|---|---|---|
| Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positiveTo promote the use of the recommended first line drug, we implement a conditional subsidy. The retail provider is given the malaria diagnostic for free and is instructed to test clients suspected of having malaria. Only if the test is positive, the provider is instructed to provide the ACT at a low cost. | Combination product | Intervention arm |
Primary outcome
ACT uptake among patients testing positive for malaria during the exit interview
Time frame: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)
The proportion of patients with malaria that purchased an ACT during their visit to the PMR. For this outcome, a patient with malaria is anyone who has a malaria RDT performed and tests positive at the exit interview.
3 secondary outcomes
Case management of patients visiting the PMR suspected of having malaria
Time frame: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approximately 30 min)]
Out of pocket expenses incurred by patients suspected of having malaria
Time frame: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approximately 30 min)]
Proportion of untested clients who purchase ACTs
Time frame: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Provide the diagnostic (RDT) for free to clients suspected of having malaria and provide a subsidized ACT to only those testing positive in people with Malaria Falciparum, run by Clinton Health Access Initiative Inc. at 1 site in Nigeria.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Apr 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 Nigeria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ACT uptake among patients testing positive for malaria during the exit interview (time frame: From enrollment exiting the PMR until the rapid test is conducted and the exit interview is concluded (approx 30 min)). 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 15 Apr 2025.