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A Randomized Experiment of Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial Aim 1 (TESTsmART)

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ClinicalTrials.gov Identifier: NCT03810014
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Moi University
Clinton Health Access Initiative, Nigeria
Information provided by (Responsible Party):
Duke University

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.


Condition or disease Intervention/treatment Phase
Malaria Febrile Illness Other: Conditional ACT subsidy, Arm 1 levels Other: Conditional ACT subsidy, Arm 2 levels Other: Conditional ACT subsidy, Arm 3 levels Other: Conditional ACT subsidy, Arm 4 levels Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

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)

Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Experiment of Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial Aim 1
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Arm 1
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
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).

Experimental: Arm 2
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
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).

Experimental: Arm 3
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
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).

Experimental: Arm 4
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
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)




Primary Outcome Measures :
  1. Proportion of participants that purchase an mRDT [ Time Frame: Cross-sectional, measured at the end of a participant's visit to participating retail outlet, up to 1 hour ]
    [Participants that purchase mRDT/ All participants]. This outcome will be evaluated once for each customer


Secondary Outcome Measures :
  1. Proportion of participants with a positive mRDT that purchased an ACT among all participants with a positive mRDT [ Time Frame: Cross-sectional, measured at the end of a participant's visit to participating retail outlet, up to 1 hour ]
    [Positive mRDT and purchased ACT/ All positive mRDT participants]

  2. Proportion of participants with a negative mRDT that did not purchase an ACT among all participants with a negative mRDT [ Time Frame: Cross-sectional, measured at the end of a participant's visit to participating retail outlet, up to 1 hour ]
    [Negative mRDT and did not purchase ACT/ All negative mRDT participants].

  3. Proportion of participants that did not purchase an mRDT and did not purchase an ACT among all participants with no mRDT [ Time Frame: Cross-sectional, measured at the end of a participant's visit to participating retail outlet, up to 1 hour ]
    [No mRDT and did not purchase ACT/ All participants with no mRDT].



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810014


Contacts
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Contact: Wendy P O'Meara, PhD 919-681-7711 wpo@duke.edu
Contact: Paige Meier paige.meier@duke.edu

Locations
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Kenya
Moi University Recruiting
Eldoret, Kenya
Contact: Jeremiah Laktabai, MMED         
Sponsors and Collaborators
Duke University
National Institute of Allergy and Infectious Diseases (NIAID)
Moi University
Clinton Health Access Initiative, Nigeria
Investigators
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Principal Investigator: Wendy P O'Meara, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03810014     History of Changes
Other Study ID Numbers: Pro00100425
1R01AI141444-01 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Malaria rapid diagnostic test (mRDT)
Artemisinin combination therapy (ACT)
Conditional subsidy
Private retail sector

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases