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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AI110478 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Moi University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Comparison Arm | No Intervention | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Malaria RDT & conditional voucher for ACT from retail sector | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a Fever Who Receive a Malaria Test From Any Source | 6 months, 12 months, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Using ACT Who Had a Positive Test | 6 months, 12 months, 18 months | |
| Number of Participants Using an ACT Who Did Not Have a Test | 6 months, 12 months, 18 months | |
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INCLUSION CRITERIA
Intervention participation criteria:
Cross sectional survey participation criteria:
EXCLUSION CRITERIA
Intervention exclusion criteria:
Cross sectional survey exclusion criteria:
• Households not in the intervention or control arms
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| Name | Affiliation | Role |
|---|---|---|
| Wendy O'Meara, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moi University | Eldoret | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37369403 | Derived | 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. | |
| 30016316 | Derived | Prudhomme 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. |
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After enrollment, 7365 participants with a fever who received a malaria test from any source were approached to complete the survey. Only those 7365 participants are considered Started. Baseline data collection occurred before randomization of clusters to the arms.
A total of 40340 participants signed consent. This is a cluster randomized trial with repeated measures; the repeated measures are independent cross-sectional samples of the population in each cluster. Participants at different time points are different participants who signed separate consent forms.
| ID | Title | Description |
|---|---|---|
| FG000 | Malaria RDT & Conditional Voucher | 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 ACT at a reduced fixed price in the retail sector conditional on a positive test. Malaria RDT & conditional voucher for ACT from retail sector: 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 |
| FG001 | Comparison Arm | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Malaria RDT & Conditional Voucher | 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 ACT at a reduced fixed price in the retail sector conditional on a positive test. Malaria RDT & conditional voucher for ACT from retail sector: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With a Fever Who Receive a Malaria Test From Any Source | Subjects with fever who completed the survey at 6, 12, or 18 months. | Posted | Count of Participants | Participants | 6 months, 12 months, 18 months |
|
18 months
Adverse event data were collected on subjects who completed the survey at baseline, 6, 12, or 18 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Malaria RDT & Conditional Voucher | 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 ACT at a reduced fixed price in the retail sector conditional on a positive test. Malaria RDT & conditional voucher for ACT from retail sector: 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy O'Meara, PhD | Duke University | 16099103091 | wpo@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2016 | Jul 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005334 | Fever |
| D008288 | Malaria |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011528 | Protozoan Infections |
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|
| 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. |
| 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). | 6 months, 12 months, 18 months |
| 28320794 | Derived | Laktabai 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. |
| BG001 | Comparison Arm | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Comparison Arm |
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
|
|
| Secondary | Number of Participants Using ACT Who Had a Positive Test | Subjects who took AL and who completed the survey at 6, 12, or 18 months. | Posted | Count of Participants | Participants | 6 months, 12 months, 18 months |
|
|
|
| Secondary | Number of Participants Using an ACT Who Did Not Have a Test | Subjects who took AL and who completed the survey at 6, 12, or 18 months. | Posted | Count of Participants | Participants | 6 months, 12 months, 18 months |
|
|
|
| Secondary | 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. | Subjects who received AL and completed the survey at 6, 12, or 18 months. | Posted | Count of Participants | Participants | 6 months, 12 months, 18 months |
|
|
|
| Secondary | 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). | Subjects with fever who completed the survey at 6, 12, or 18 months. | Posted | Count of Participants | Participants | 6 months, 12 months, 18 months |
|
|
|
| 0 |
| 3,729 |
| 0 |
| 3,729 |
| 0 |
| 3,729 |
| EG001 | Comparison Arm | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. | 0 | 3,625 | 0 | 3,625 | 0 | 3,625 |
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| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| 12 Months |
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| 18 months |
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| 12 Months |
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| 18 months |
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| 12 Months |
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| 18 months |
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|
| 12 Months |
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| 18 months |
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