Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial AIM 1

NCT03810014 | Completed Results

• 2 other identifiers: Pro001004251R01AI141444-01
• Study Type: interventional
• Target: 842
• Locations: 1 country
• Sites: 1

Brief Summary

The TESTsmART Trial consists of two main aims. The overall goal of the two aims is to investigate the impact of malaria rapid diagnostic test (mRDT) subsidies and conditional artemisinin combination therapy (ACT) subsidies on the testing and treatment behavior of participants seeking care for their febrile illness in the private retail sector. Conditional ACT subsidies are discounts on quality-assured ACTs which are linked to the results of a malaria rapid diagnostic test administered at the retail outlet; only participants with a positive test will have access to an additional discount on a quality-assured ACT. The main objective of Aim 1 of this study is to identify a combination of conditional ACT and RDT subsidies that maximizes the proportion of participants that choose to have a malaria diagnostic test before taking a drug. The investigators will test two levels of conditional ACT subsidy (100% subsidy versus \~67% subsidy) and two levels of RDT subsidy (0% subsidy and 50% subsidy) in a factorial designed experiment. Because dose size and therefore the price of an ACT course are dependent upon patient age, the ACT subsidy amount will also be scaled with patient age. These subsidy levels were chosen to keep the estimated program cost of the combined subsidy within $0.30-0.60 USD per person (assuming 100% testing uptake and between 20-40% of participants having a positive RDT). These estimates represent an upper bound since testing is unlikely to reach 100%. Current subsidy levels for ACT costs the program between 1.30-2.50 USD per treatment, with more than a third of that investment spent on individuals without malaria. Individuals presenting to a retail outlet for a treatment of a fever or suspected malaria illness will be randomized to one of the four groups in equal proportions. A total of 840 participants will be enrolled (210 per arm). Their choices concerning uptake of testing and drug purchase will be recorded. The main outcome will be the proportion of participants that choose to take a test. Secondary outcomes include the proportion of participants who adhered to the results of the RDT among those who were tested (used ACT when positive and did not use an ACT when negative or without a test). The results of this study will be used to inform the subsidy levels in the intervention for Aim 2 of this trial.

Conditions

Malaria; Febrile Illness

Keywords

rapid diagnostic test (RDT); Artemisinin combination therapy (ACT); Conditional subsidy; Private retail sector

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Purchase an mRDT (Malaria Rapid Diagnostic Test)

  This outcome will be evaluated once for each customer

  At the end of a participant's visit to participating retail outlet, up to 1 hour

Secondary Outcomes (3)

• Number of Participants With a Positive mRDT That Purchased an ACT (Artemisinin-based Combination Therapy)

  At the end of a participant's visit to participating retail outlet, up to 1 hour

• Number of Participants With a Negative mRDT That Did Not Purchase an ACT

  At the end of a participant's visit to participating retail outlet, up to 1 hour

• Number of Participants That Did Not Purchase an mRDT and Did Not Purchase an ACT

  At the end of a participant's visit to participating retail outlet, up to 1 hour

Study Arms (4)

Arm 1

EXPERIMENTAL

The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).

Other: Conditional ACT subsidy, Arm 1 levels

Arm 2

EXPERIMENTAL

The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).

Other: Conditional ACT subsidy, Arm 2 levels

Arm 3

EXPERIMENTAL

The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).

Other: Conditional ACT subsidy, Arm 3 levels

Arm 4

EXPERIMENTAL

The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)

Other: Conditional ACT subsidy, Arm 4 levels

Interventions

Conditional ACT subsidy, Arm 1 levels OTHER

The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).

Arm 1

Conditional ACT subsidy, Arm 2 levels OTHER

The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).

Arm 2

Conditional ACT subsidy, Arm 3 levels OTHER

The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).

Arm 3

Conditional ACT subsidy, Arm 4 levels OTHER

The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)

Arm 4

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 or malaria like illness
• Individual with malaria-like illness must be present at recruitment
• year of age or older

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
• Individuals who already have a prescription from a facility or medical provider
• Pregnant women will be enrolled and offered an mRDT, but will be advised to seek treatment through a health care provider.

Sponsors & Collaborators

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

Study Sites (1)

Moi University

Eldoret, Kenya

Location

Related Publications (1)

• Saran I, Laktabai J, Menya D, Woolsey A, Turner EL, Visser T, O'Meara WP. How do malaria testing and treatment subsidies affect drug shop client expenditures? A cross-sectional analysis in Western Kenya. BMJ Open. 2022 Dec 6;12(12):e066814. doi: 10.1136/bmjopen-2022-066814.

  PMID: 36600353 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 P O'Meara, PhD
• Organization: Duke University

wpo@duke.edu

919-681-7711

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: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A factorial design will be used to test two ACT subsidy levels and two RDT subsidy levels. The unit of randomization will be the individual customer. Using scratch cards, participants will be randomized, in a 1:1:1:1 ratio, to one of four study arms: 1\) No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=$0) // 2) No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer= $0.10-0.40, dependent upon patient age) // 3) 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0) // 4) 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 18, 2019
• Study Start: March 28, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: November 12, 2020
• Results First Posted: November 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)