N/A
Completed N=7,365
Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)
Source: ClinicalTrials.gov NCT02461628 ↗Enrolled (actual)
7,365
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Number of Subjects With a Fever Who Receive a Malaria Test From Any Source — 384; 402; 443; 391 Participants
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With a Fever Who Receive a Malaria Test From Any Source |
384; 402; 443; 391; 547; 406 | — |
| SECONDARY Number of Participants Using ACT Who Had a Positive Test |
234; 305; 280; 286; 426; 302 | — |
| SECONDARY Number of Participants Using an ACT Who Did Not Have a Test |
252; 237; 260; 363; 271; 354 | — |
| SECONDARY Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine) |
338; 352; 376; 391; 496; 410 | — |
| SECONDARY Number of Subjects With Fever That Received Correct Treatment |
309; 340; 344; 306; 462; 321 | — |
Eligibility Criteria
INCLUSION CRITERIA
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
EXCLUSION CRITERIA
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
Data sourced from ClinicalTrials.gov (NCT02461628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.