Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE January 16, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date April 5, 2019
Actual Study Start Date  ICMJE March 28, 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03810014 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
  • 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]
  • 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].
  • 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].
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Experiment of Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial Aim 1
Official Title  ICMJE A Randomized Experiment of Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial Aim 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Malaria
  • Febrile Illness
Intervention  ICMJE
  • 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).
  • 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).
  • 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).
  • 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)
Study Arms  ICMJE
  • 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).
    Intervention: Other: Conditional ACT subsidy, Arm 1 levels
  • 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).
    Intervention: Other: Conditional ACT subsidy, Arm 2 levels
  • 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).
    Intervention: Other: Conditional ACT subsidy, Arm 3 levels
  • 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)
    Intervention: Other: Conditional ACT subsidy, Arm 4 levels
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2019)
840
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wendy P O'Meara, PhD 919-681-7711 wpo@duke.edu
Contact: Paige Meier paige.meier@duke.edu
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810014
Other Study ID Numbers  ICMJE Pro00100425
1R01AI141444-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Moi University
  • Clinton Health Access Initiative, Nigeria
Investigators  ICMJE
Principal Investigator: Wendy P O'Meara, PhD Duke University
PRS Account Duke University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP