Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)

• ClinicalTrials.gov Identifier: NCT02461628
• Recruitment Status: Completed
• First Posted: June 3, 2015
• Results First Posted: October 29, 2019
• Last Update Posted: October 29, 2019
• Sponsor: Duke University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Moi University
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fever; Malaria	Behavioral: Malaria RDT & conditional voucher for ACT from retail sector	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40340 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector
• Study Start Date: July 2015
• Actual Primary Completion Date: May 26, 2017
• Actual Study Completion Date: July 12, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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 artemisinin combination therapy (ACT) at a reduced fixed price in the retail sector conditional on a positive test.	Behavioral: 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
No Intervention: Comparison Arm; Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects With a Fever Who Receive a Malaria Test From Any Source [ Time Frame: 6 months, 12 months, 18 months ]

Secondary Outcome Measures :

1. Number of Participants Using ACT Who Had a Positive Test [ Time Frame: 6 months, 12 months, 18 months ]
2. Number of Participants Using an ACT Who Did Not Have a Test [ Time Frame: 6 months, 12 months, 18 months ]
3. Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine) [ Time Frame: 6 months, 12 months, 18 months ]
   Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.
4. Number of Subjects With Fever That Received Correct Treatment [ Time Frame: 6 months, 12 months, 18 months ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 1 Year and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Kenya

Moi University

Eldoret, Kenya

Sponsors and Collaborators

Duke University

National Institute of Allergy and Infectious Diseases (NIAID)

Moi University

Investigators

• Principal Investigator: Wendy O'Meara, PhD; Duke University

  Study Documents (Full-Text)

Documents provided by Duke University:

Study Protocol and Statistical Analysis Plan  [PDF] June 23, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02461628
• Other Study ID Numbers: Pro00063384; 5R01AI110478 ( U.S. NIH Grant/Contract )
• First Posted: June 3, 2015
• Results First Posted: October 29, 2019
• Last Update Posted: October 29, 2019
• Last Verified: October 2019

Keywords provided by Duke University:

Malaria; Antimalarial subsidy; Malaria rapid diagnostic test (RDT); Public-private partnership; Community health workers

Additional relevant MeSH terms:

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases