Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: TESTsmART Aim 2 - Kenya

NCT04428307 | Completed Results

• 2 other identifiers: Pro001042565R01AI141444-02
• Study Type: interventional
• Target: 5,696
• Locations: 1 country
• Sites: 1

Brief Summary

Highly subsidized first-line antimalarials (artemisinin combination therapy or ACT) are available over the counter in the private retail sector in most malaria-endemic countries. Overconsumption of ACTs purchased over the counter is rampant due to their low price, high perceived efficacy, and absence of diagnostic tools to guide drug use. The ultimate goal of the proposed work is to improve antimalarial stewardship in the retail sector, which is responsible for distributing the majority of antimalarials in sub-Saharan Africa. Through a combination of diagnosis and treatment subsidies and provider-directed incentives, this approach will align provider and customer incentives with appropriate case management and thereby improve health outcomes. The main objective of this study (Aim 2) is to test two key interventions in a random sample of private medicine retail outlets in Kenya. This will be a cluster-randomized controlled trial where the cluster is a private retail outlet that stocks and sells WHO quality-assured ACTs. This three-arm study will test 1) a consumer-directed intervention in the form of a diagnosis-dependent ACT subsidy, 2) both a provider-directed incentive for testing and a client-directed intervention in combination against 3) a comparison arm. Outlets in all three arms will offer malaria diagnostic testing to customers who wish to purchase one. Information for the primary and secondary outcomes will be collected during exit interviews with eligible customers. The primary outcome will be the proportion of ACTs sold to customers with a positive diagnostic test. The main secondary outcome will be the proportion of suspected malaria cases presenting to the retail outlet that are tested. Other secondary outcomes include adherence to the RDT result amongst those tested (defined as taking a quality-assured ACT following a positive test and refraining from taking an ACT following a negative test) and appropriate case management for all suspected malaria cases (proportion tested and adhered among all suspected cases).

Conditions

Malaria; Febrile Illness

Keywords

treatment seeking in the informal (retail) health sector; malaria diagnostic testing; rational drug use

Outcome Measures

Primary Outcomes (1)

• ACT (Artemisinin Combination Therapy) Consumption by True Malaria Cases

  Number of participants who purchased ACTs and were malaria test-positive. Malaria test-positivity was based on mRDT testing testing at the outlet or documented testing brought to the facility.

  Day of enrollment

Secondary Outcomes (4)

• Use of Malaria Rapid Diagnostic Test

  Day of enrollment

• Adherence to the RDT (Rapid Diagnostic Test) Result Among All Those Tested in the Shop

  Day of enrollment

• Appropriate Case Management

  Day of enrollment

• ACT (Artemisinin Combination Therapy) Use Among Untested Clients

  Day of enrollment

Study Arms (3)

Arm 1 (control)

NO INTERVENTION

RDTs available at study-recommended price, providers trained on mobile reporting app

Arm 2 (client-directed intervention)

EXPERIMENTAL

ACT subsidy to client conditional on positive RDT, RDTs available at study-recommended price

Other: Conditional artemisinin combination therapy subsidy

Arm 3 (client-directed and provider-directed intervention)

EXPERIMENTAL

providers receive a small payment for each RDT that they perform and consumers with a positive test are eligible for a subsidy on a quality-assured ACT, RDTs are available at study recommended price

Other: Conditional artemisinin combination therapy subsidy; Other: Testing incentive

Interventions

Conditional artemisinin combination therapy subsidy OTHER

An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.

Arm 2 (client-directed intervention); Arm 3 (client-directed and provider-directed intervention)

Testing incentive OTHER

A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.

Arm 3 (client-directed and provider-directed intervention)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with fever, or history of fever in the last 48 hours, or suspects they may have malaria
• Individual with malaria-like illness must be present at recruitment
• Older than one year of age

You may not qualify if:

• Any individual with signs of severe illness requiring immediate referral
• Individuals who have taken an antimalarial in the last seven days, including for the current illness
• Patients \<18 years without a parent or legal guardian present

Sponsors & Collaborators

• Duke University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Moi University: collaborator
• Clinton Health Access Initiative Inc.: collaborator

Study Sites (1)

Moi University

Eldoret, Kenya

Location

Related Publications (3)

• Visser T, Laktabai J, Kimachas E, Kipkoech J, Menya D, Arthur D, Zhou Y, Chepkwony T, Abel L, Robie E, Amunga M, Ambani G, Uhomoibhi P, Ogbulafor N, Oshinowo B, Ogunsola O, Woldeghebriel M, Garber E, Olaleye T, Eze N, Nwidae L, Mudabai P, Gallis JA, Fashanu C, Saran I, Woolsey A, Turner EL, Prudhomme O'Meara W. A cluster-randomized trial of client and provider directed financial interventions to align incentives with appropriate case management in private medicine retailers: results of the TESTsmART Trial in Lagos, Nigeria. medRxiv [Preprint]. 2024 Jan 31:2024.01.30.24302026. doi: 10.1101/2024.01.30.24302026.

  PMID: 38352390 DERIVED

• Laktabai J, Kimachas E, Kipkoech J, Menya D, Arthur D, Zhou Y, Chepkwony T, Abel L, Robie E, Amunga M, Ambani G, Woldeghebriel M, Garber E, Eze N, Mudabai P, Gallis JA, Fashanu C, Saran I, Woolsey A, Visser T, Turner EL, Prudhomme O'Meara W. A cluster-randomized trial of client and provider-directed financial interventions to align incentives with appropriate case management in retail medicine outlets: Results of the TESTsmART Trial in western Kenya. PLOS Glob Public Health. 2024 Feb 7;4(2):e0002451. doi: 10.1371/journal.pgph.0002451. eCollection 2024.

  PMID: 38324584 DERIVED

• Woolsey AM, Simmons RA, Woldeghebriel M, Zhou Y, Ogunsola O, Laing S, Olaleye T, Kipkoech J, Rojas BM, Saran I, Odhiambo M, Malinga J, Ambani G, Kimachas E, Fashanu C, Wiwa O, Menya D, Laktabai J, Visser T, Turner EL, O'Meara WP. Incentivizing appropriate malaria case management in the private sector: a study protocol for two linked cluster randomized controlled trials to evaluate provider- and client-focused interventions in western Kenya and Lagos, Nigeria. Implement Sci. 2021 Jan 20;16(1):14. doi: 10.1186/s13012-020-01077-w.

  PMID: 33472650 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Results Point of Contact

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

wendy.omeara@duke.edu

919-613-4406

Study Officials

• Wendy P O'Meara, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interviewers assessing outcomes and statisticians will be blinded to arm assignment
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: three-arm parallel cluster randomized trial

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: January 11, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: February 20, 2024
• Results First Posted: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)