FeverNCT02461628
Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)
A study testing Malaria RDT & conditional voucher for ACT from retail sector in people with Fever and Malaria, run by Duke University at 1 site in Kenya.
Trial summary
The overall objective of this study is to evaluate the public health impact of targeted antimalarials subsidies through scale-up by determining the community-wide effects of targeting an antimalarial subsidy through a partnership between Community Health Volunteers (CHVs) and the private retail sector. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- What is being tested?
- Malaria RDT & conditional voucher for ACT from retail sector
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,340 participants
- Where
- 1 siteKenya
- Study dates
- Jul 2015to 12 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Intervention participation criteria:
- Client is older than 1 year
- Client has fever or history of fever or feeling unwell with a malaria-like illness within the last 2 days
- Client or their parent/legal guardian (if under 18) consents to participate
- Cross sectional survey participation criteria:
- Household representative in the intervention or control arm
- At least one member in the respondent's household with a history of fever or feeling unwell with a malaria like illness within the last four weeks
- Respondent is older than 18 years
Who cannot join
- Intervention exclusion criteria:
- Client has signs of severe disease or other problem requiring immediate referral to a health facility
- Client has already visited a health facility, taken or purchased antimalarials for the current illness.
- Cross sectional survey exclusion criteria:
- Households not in the intervention or control arms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector
The overall objective of this study is to evaluate the public health impact of targeted antimalarials subsidies through scale-up by determining the community-wide effects of targeting an antimalarial subsidy through a partnership between Community Health Volunteers (CHVs) and the private retail sector. The primary hypothesis to be tested is that offering a fixed-price voucher that reduces the cost for artemisinin combination therapy (ACT) purchase in the retail sector conditional on a positive malaria test (targeted subsidy) can improve uptake of testing for malaria and will increase the proportion of fevers tested for malaria before treatment. The study will be carried out in two sub-counties in Kenya with similar malaria burden but different access to health services; the investigators will use a cluster-randomized design to assign community units (CUs) in each sub-county to either an intervention or control arm. CHVs will be trained to use malaria rapid diagnostic tests (RDTs) to diagnose malaria in household members with documented or reported fever; households in intervention CUs will be informed of the intervention and encouraged to contact the CHV for any febrile illness in the home. There are minimal risks associated with receiving an RDT. Households with a positive RDT will be given a serialized voucher that will entitle the holder to purchase a quality assured ACT in the retail sector at a reduced, fixed price. The primary and secondary outcome measures will be compared at baseline and 12 months post-baseline through population-based surveying. The primary aim is to determine whether there is significant difference between the 2 study arms in the proportion of clients with fever who are tested prior to any treatment after adjusting for relevant covariates.
- Being tested
- Malaria RDT & conditional voucher for ACT from retail sector
- Keywords
- Malaria, Antimalarial subsidy, Malaria rapid diagnostic test (RDT), Public-private partnership, Community health workers
- Medical subject headings
- Fever, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malaria RDT & conditional voucher for ACT from retail sectorBehavioural
Trained community health volunteers will offer eligible household members free malaria rapid diagnostic tests and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test
| Study group | Role | What they receive |
|---|---|---|
| Malaria RDT & conditional voucher | Experimental | In the intervention arm, trained community health volunteers (CHVs) will offer eligible household members a free malaria rapid diagnostic test (RDT) and a voucher allowing the purchase of a qualified artemisinin combination therapy (ACT) at a reduced fixed price in the retail sector conditional on a positive test. Receives: Behavioral: Malaria RDT & conditional voucher for ACT from retail sector |
| Comparison Arm | No intervention | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source
Measured: 6 months, 12 months, 18 months
Secondary outcomes (4)
Number of Participants Using ACT Who Had a Positive Test
Measured: 6 months, 12 months, 18 months
Number of Participants Using an ACT Who Did Not Have a Test
Measured: 6 months, 12 months, 18 months
Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)
Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.
Measured: 6 months, 12 months, 18 months
Number of Subjects With Fever That Received Correct Treatment
The number of people with fever that report receiving correct treatment with regards to malaria (i.e., received an RDT test and took ACTs if the result was positive, or did not take ACTs if the test result was negative).
Measured: 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion26 May 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)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
- 40,340 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
- NCT02461628
- Sponsor's protocol ID
- Pro00063384
- Other IDs
- 5R01AI110478
- Status last verified
- Oct 2019
- First submitted
- 28 May 2015
- Last updated
- 29 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kirui J, Malinga J, Sang E, Ambani G, Abel L, Nalianya E, Namae J, Boyce M, Laktabai J, Menya D, O'Meara W. Supply-side and demand-side factors influencing uptake of malaria testing services in the community: lessons for scale-up from a post-hoc analysis of a cluster randomised, community-based trial in western Kenya. BMJ Open. 2023 Jun 26;13(6):e070482. doi: 10.1136/bmjopen-2022-070482.
PubMed 37369403Prudhomme O'Meara W, Menya D, Laktabai J, Platt A, Saran I, Maffioli E, Kipkoech J, Mohanan M, Turner EL. Improving rational use of ACTs through diagnosis-dependent subsidies: Evidence from a cluster-randomized controlled trial in western Kenya. PLoS Med. 2018 Jul 17;15(7):e1002607. doi: 10.1371/journal.pmed.1002607. eCollection 2018 Jul.
PubMed 30016316Laktabai J, Lesser A, Platt A, Maffioli E, Mohanan M, Menya D, Prudhomme O'Meara W, Turner EL. Innovative public-private partnership to target subsidised antimalarials: a study protocol for a cluster randomised controlled trial to evaluate a community intervention in Western Kenya. BMJ Open. 2017 Mar 20;7(3):e013972. doi: 10.1136/bmjopen-2016-013972.
PubMed 28320794
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector
- ClinicalTrials.gov ID
- NCT02461628
- Acronym / sponsor ID
- Pro00063384
- Keywords
- Malaria, Antimalarial subsidy, Malaria rapid diagnostic test (RDT), Public-private partnership, Community health workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40,340 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Moi University
- Study start
- Jul 2015
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Posted 29 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to evaluate the public health impact of targeted antimalarials subsidies through scale-up by determining the community-wide effects of targeting an antimalarial subsidy through a partnership between Community Health Volunteers (CHVs) and the private retail sector. The primary hypothesis to be tested is that offering a fixed-price voucher that reduces the cost for artemisinin combination therapy (ACT) purchase in the retail sector conditional on a positive malaria test (targeted subsidy) can improve uptake of testing for malaria and will increase the proportion of fevers tested for malaria before treatment. The study will be carried out in two sub-counties in Kenya with similar malaria burden but different access to health services; the investigators will use a cluster-randomized design to assign community units (CUs) in each sub-county to either an intervention or control arm. CHVs will be trained to use malaria rapid diagnostic tests (RDTs) to diagnose malaria in household members with documented or reported fever; households in intervention CUs will be informed of the intervention and encouraged to contact the CHV for any febrile illness in the home. There are minimal risks associated with receiving an RDT. Households with a positive RDT will be given a serialized voucher that will entitle the holder to purchase a quality assured ACT in the retail sector at a reduced, fixed price. The primary and secondary outcome measures will be compared at baseline and 12 months post-baseline through population-based surveying. The primary aim is to determine whether there is significant difference between the 2 study arms in the proportion of clients with fever who are tested prior to any treatment after adjusting for relevant covariates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malaria RDT & conditional voucher | Experimental | Behavioral: Malaria RDT & conditional voucher for ACT from retail sectorIn the intervention arm, trained community health volunteers (CHVs) will offer eligible household members a free malaria rapid diagnostic test (RDT) and a voucher allowing the purchase of a qualified artemisinin combination therapy (ACT) at a reduced fixed price in the retail sector conditional on a positive test. |
| Comparison Arm | No intervention | –Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 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 2 days
- Client or their parent/legal guardian (if under 18) consents to participate
- Household representative in the intervention or control arm
- At least one member in the respondent's household with a history of fever or feeling unwell with a malaria like illness within the last four weeks
Key exclusion criteria (5 listed)
- Client has signs of severe disease or other problem requiring immediate referral to a health facility
- Client has already visited a health facility, taken or purchased antimalarials for the current illness.
- Households not in the intervention or control arms
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 |
|---|---|---|
| Malaria RDT & conditional voucher for ACT from retail sectorTrained community health volunteers will offer eligible household members free malaria rapid diagnostic tests and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test | Behavioural | Malaria RDT & conditional voucher |
Primary outcome
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source
Time frame: 6 months, 12 months, 18 months
4 secondary outcomes
Number of Participants Using ACT Who Had a Positive Test
Time frame: 6 months, 12 months, 18 months
Number of Participants Using an ACT Who Did Not Have a Test
Time frame: 6 months, 12 months, 18 months
Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)
Time frame: 6 months, 12 months, 18 months
Number of Subjects With Fever That Received Correct Treatment
Time frame: 6 months, 12 months, 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37369403Kirui J, Malinga J, Sang E, Ambani G, Abel L, Nalianya E, Namae J, Boyce M, Laktabai J, Menya D, O'Meara W. Supply-side and demand-side factors influencing uptake of malaria testing services in the community: lessons for scale-up from a post-hoc analysis of a cluster randomised, community-based trial in western Kenya. BMJ Open. 2023 Jun 26;13(6):e070482. doi: 10.1136/bmjopen-2022-070482.
- Derived from this study: PubMed 30016316Prudhomme O'Meara W, Menya D, Laktabai J, Platt A, Saran I, Maffioli E, Kipkoech J, Mohanan M, Turner EL. Improving rational use of ACTs through diagnosis-dependent subsidies: Evidence from a cluster-randomized controlled trial in western Kenya. PLoS Med. 2018 Jul 17;15(7):e1002607. doi: 10.1371/journal.pmed.1002607. eCollection 2018 Jul.
- Derived from this study: PubMed 28320794Laktabai J, Lesser A, Platt A, Maffioli E, Mohanan M, Menya D, Prudhomme O'Meara W, Turner EL. Innovative public-private partnership to target subsidised antimalarials: a study protocol for a cluster randomised controlled trial to evaluate a community intervention in Western Kenya. BMJ Open. 2017 Mar 20;7(3):e013972. doi: 10.1136/bmjopen-2016-013972.
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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 Malaria RDT & conditional voucher for ACT from retail sector 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 8 inclusion and 5 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 29 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source (time frame: 6 months, 12 months, 18 months). 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 NCT02461628, which also lists 3 linked publications.
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 29 Oct 2019.