Clinical trial NCT02461628: Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)
Official title: Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Malaria
Keywords: Malaria
Antimalarial subsidy
Malaria rapid diagnostic test (RDT)
Public-private partnership
Community health workers
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Moi University
First posted: 2015-06-03
Enrollment: 40340
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


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

Primary outcomes:
measure: Number of Subjects With a Fever Who Receive a Malaria Test From Any Source
timeFrame: 6 months, 12 months, 18 months
Secondary outcomes:
measure: Number of Participants Using ACT Who Had a Positive Test
timeFrame: 6 months, 12 months, 18 months
measure: Number of Participants Using an ACT Who Did Not Have a Test
timeFrame: 6 months, 12 months, 18 months
measure: Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)
timeFrame: 6 months, 12 months, 18 months
measure: Number of Subjects With Fever That Received Correct Treatment
timeFrame: 6 months, 12 months, 18 months
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi University
Study officials:
affiliation: Duke University
name: Wendy O'Meara, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.