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

NCT02461628 | Completed Results

• 2 other identifiers: Pro000633845R01AI110478
• Study Type: interventional
• Target: 40,340
• Locations: 1 country
• Sites: 1

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.

Conditions

Fever; Malaria

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With a Fever Who Receive a Malaria Test From Any Source

  6 months, 12 months, 18 months

Secondary Outcomes (4)

• 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

• Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)

  6 months, 12 months, 18 months

• Number of Subjects With Fever That Received Correct Treatment

  6 months, 12 months, 18 months

Study Arms (2)

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.

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.

Interventions

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

Malaria RDT & conditional voucher

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Moi University: collaborator

Study Sites (1)

Moi University

Eldoret, Kenya

Location

Related Publications (3)

• 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.

  PMID: 37369403 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.

  PMID: 30016316 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.

  PMID: 28320794 DERIVED

MeSH Terms

Conditions

Fever; Malaria

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Results Point of Contact

• Title: Wendy O'Meara, PhD
• Organization: Duke University

wpo@duke.edu

16099103091

Study Officials

• Wendy O'Meara, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 3, 2015
• Study Start: July 1, 2015
• Primary Completion: May 26, 2017
• Study Completion: July 12, 2017
• Last Updated: October 29, 2019
• Results First Posted: October 29, 2019

Record last verified: 2019-10

Locations

KE (1)