FeverNCT02199977
Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector
A study testing Free Malaria Rapid Diagnostic Test, Conditional ACT voucher and Malaria Rapid Diagnostic test for a charge in people with Fever and Malaria, run by Duke University at 1 site in Kenya.
Trial summary
There are compelling medical and public health reasons to reduce unnecessary consumption of antimalarials and strong evidence to support the use of RDTs in malaria case management. Read more about this study
- Who is it for?
- Ages 1 year and older
- What is being tested?
- Free Malaria Rapid Diagnostic Test, Conditional ACT voucher and Malaria Rapid Diagnostic test for a charge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteKenya
- Study dates
- Jun 2014to Jul 2015
- Phase
- Interventional
- 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
- Client is older than 1 year
- Client has fever or history of fever or feeling unwell with a malaria-like illness within the last 24 hours
- Client or their parent/legal guardian consents to participate
Who cannot join
- Client has signs of severe disease or other problem requiring immediate referral to a community health worker (CHW) / health facility
- Client has already sought treatment, purchased medicine or taken medicine for the current illness.
- Note:
- If more than one febrile person who meet the inclusion criteria are found in a single household, all of the individuals will be enrolled in the same group, but only one individual (the first enrolled) will be used for the purposes of the analysis.
Trial locations and contacts
1 site in 1 country.
About this study
There are compelling medical and public health reasons to reduce unnecessary consumption of antimalarials and strong evidence to support the use of RDTs in malaria case management. The primary study hypothesis to be tested is that clients who know they will receive a subsidy conditional on a positive test are more likely to opt for testing before deciding which drug to buy. The primary endpoint is whether subjects choose to be tested for malaria with a rapid diagnostic test. The secondary endpoint is whether they purchased an artemisinin combination therapy (ACT) or not. The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test (Group A compared to Group B) compared to those without the offer of a conditional subsidy. The investigators will use an experimental design that randomly assigns clients to one of four groups. Field workers will canvas households in the study area looking for individuals who have fever or history of fever or illness in the last 24 hours (current illness) who have not yet taken drugs or sought treatment outside the home. Clients who meet the inclusion criteria and give verbal consent to participate will be randomly assigned to one of the four groups. They will be given the location and contact information for their local community health worker who can provide a malaria rapid diagnostic test if they choose to be tested. They will also complete a survey tool. One week later, the field worker will return to interview the participant and determine whether they were tested, what action they took for their illness, what medicine they purchased and how much they paid. The investigators will summarize clients' choice by the four randomized study groups.
- Being tested
- Free Malaria Rapid Diagnostic Test, Conditional ACT voucher, Malaria Rapid Diagnostic test for a charge
- Keywords
- Malaria, Antimalarial subsidy, Malaria rapid diagnostic test (RDT), public-private partnership
- Medical subject headings
- Fever, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Malaria Rapid Diagnostic TestOther
Malaria RDT is offered free if patients choose to be tested
Conditional ACT voucherOther
Participants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test. When a conditional subsidy is offered, it is valid for use on a "Green Leaf" approved malaria drug.
Malaria Rapid Diagnostic test for a chargeOther
Participants can receive a malaria RDT for a set amount (i.e., not for free).
| Study group | Role | What they receive |
|---|---|---|
| test only (free) | Other | The participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher. Receives: Other: Free Malaria Rapid Diagnostic Test |
| test (free) & conditional ACT voucher | Other | The participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result. Receives: Other: Free Malaria Rapid Diagnostic Test; Other: Conditional ACT voucher |
| test only (not free) | Other | The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), but no ACT voucher. Receives: Other: Malaria Rapid Diagnostic test for a charge |
| test (not free) & conditional ACT voucher | Other | The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), and an ACT voucher conditional on a positive test result. Receives: Other: Conditional ACT voucher; Other: Malaria Rapid Diagnostic test for a charge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test
The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test compared to those without the offer of a conditional subsidy.
Measured: Within two days of group assignment
Secondary outcomes (2)
Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)
Measured: Within 2 days of group assignment
Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.
Measured: Within 2 days of group assignment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Moi University
- Responsible party
- Sponsor
- Investigators
- Wendy O'Meara, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199977
- Sponsor's protocol ID
- Pro00052602
- Other IDs
- 1R01AI110478-01
- Status last verified
- Dec 2015
- First submitted
- 22 Jul 2014
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Prudhomme O'Meara W, Mohanan M, Laktabai J, Lesser A, Platt A, Maffioli E, Turner EL, Menya D. Assessing the independent and combined effects of subsidies for antimalarials and rapid diagnostic testing on fever management decisions in the retail sector: results from a factorial randomised trial in western Kenya. BMJ Glob Health. 2016 Sep 28;1(2):e000101. doi: 10.1136/bmjgh-2016-000101. eCollection 2016.
PubMed 28588946
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector
- ClinicalTrials.gov ID
- NCT02199977
- Acronym / sponsor ID
- Pro00052602
- Keywords
- Malaria, Antimalarial subsidy, Malaria rapid diagnostic test (RDT), public-private partnership
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Moi University
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Jul 2014 (estimated)
- 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.
There are compelling medical and public health reasons to reduce unnecessary consumption of antimalarials and strong evidence to support the use of RDTs in malaria case management. The primary study hypothesis to be tested is that clients who know they will receive a subsidy conditional on a positive test are more likely to opt for testing before deciding which drug to buy. The primary endpoint is whether subjects choose to be tested for malaria with a rapid diagnostic test. The secondary endpoint is whether they purchased an artemisinin combination therapy (ACT) or not. The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test (Group A compared to Group B) compared to those without the offer of a conditional subsidy. The investigators will use an experimental design that randomly assigns clients to one of four groups. Field workers will canvas households in the study area looking for individuals who have fever or history of fever or illness in the last 24 hours (current illness) who have not yet taken drugs or sought treatment outside the home. Clients who meet the inclusion criteria and give verbal consent to participate will be randomly assigned to one of the four groups. They will be given the location and contact information for their local community health worker who can provide a malaria rapid diagnostic test if they choose to be tested. They will also complete a survey tool. One week later, the field worker will return to interview the participant and determine whether they were tested, what action they took for their illness, what medicine they purchased and how much they paid. The investigators will summarize clients' choice by the four randomized study groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| test only (free) | Other | Other: Free Malaria Rapid Diagnostic TestThe participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher. |
| test (free) & conditional ACT voucher | Other | Other: Free Malaria Rapid Diagnostic Test, Other: Conditional ACT voucherThe participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result. |
| test only (not free) | Other | Other: Malaria Rapid Diagnostic test for a chargeThe participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), but no ACT voucher. |
| test (not free) & conditional ACT voucher | Other | Other: Conditional ACT voucher, Other: Malaria Rapid Diagnostic test for a chargeThe participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), and an ACT voucher conditional on a positive test result. |
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)
- Client is older than 1 year
- Client has fever or history of fever or feeling unwell with a malaria-like illness within the last 24 hours
- Client or their parent/legal guardian consents to participate
Key exclusion criteria (4 listed)
- Client has signs of severe disease or other problem requiring immediate referral to a community health worker (CHW) / health facility
- Client has already sought treatment, purchased medicine or taken medicine for the current illness.
- If more than one febrile person who meet the inclusion criteria are found in a single household, all of the individuals will be enrolled in the same group, but only one individual (the first enrolled) will be used for the purposes of the analysis.
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 |
|---|---|---|
| Free Malaria Rapid Diagnostic TestMalaria RDT is offered free if patients choose to be tested | Other | test (free) & conditional ACT voucher, test only (free) |
| Conditional ACT voucherParticipants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test. When a conditional subsidy is offered, it is valid for use on a "Green Leaf" approved malaria drug. | Other | test (free) & conditional ACT voucher, test (not free) & conditional ACT voucher |
| Malaria Rapid Diagnostic test for a chargeParticipants can receive a malaria RDT for a set amount (i.e., not for free). | Other | test (not free) & conditional ACT voucher, test only (not free) |
Primary outcome
Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test
Time frame: Within two days of group assignment
The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test compared to those without the offer of a conditional subsidy.
2 secondary outcomes
Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)
Time frame: Within 2 days of group assignment
Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.
Time frame: Within 2 days of group assignment
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 Dec 2015.
- Derived from this study: PubMed 28588946Prudhomme O'Meara W, Mohanan M, Laktabai J, Lesser A, Platt A, Maffioli E, Turner EL, Menya D. Assessing the independent and combined effects of subsidies for antimalarials and rapid diagnostic testing on fever management decisions in the retail sector: results from a factorial randomised trial in western Kenya. BMJ Glob Health. 2016 Sep 28;1(2):e000101. doi: 10.1136/bmjgh-2016-000101. eCollection 2016.
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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.
Wendy O'Meara, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Malaria Rapid Diagnostic Test, Conditional ACT voucher and Malaria Rapid Diagnostic test for a charge in people with Fever and Malaria, run by Duke University at 1 site in Kenya.
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 Dec 2015. 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 Kenya. 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.
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?
Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test (time frame: Within two days of group assignment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02199977, which also lists 1 linked publication.
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 Dec 2015.