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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02461628
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Moi University
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE May 28, 2015
First Posted Date  ICMJE June 3, 2015
Results First Submitted Date  ICMJE July 22, 2019
Results First Posted Date  ICMJE October 29, 2019
Last Update Posted Date October 29, 2019
Study Start Date  ICMJE July 2015
Actual Primary Completion Date May 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2019)
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source [ Time Frame: 6 months, 12 months, 18 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
Comparison of percent of fevers that receive a malaria test from any source between arms. [ Time Frame: 18 months post-baseline ]
The primary outcome of this study is to compare the percent of fevers that receive a malaria test from any source between the intervention and control arms. While the outcome will be measured in three regularly spaced population-based cross-sectional surveys (6 months, 12 months, and 18 months post-baseline), the primary endpoint will be evaluated at 18 months post-baseline. Additional information will be provided by the two other timepoints.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2019)
  • Number of Participants Using ACT Who Had a Positive Test [ Time Frame: 6 months, 12 months, 18 months ]
  • Number of Participants Using an ACT Who Did Not Have a Test [ Time Frame: 6 months, 12 months, 18 months ]
  • Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine) [ Time Frame: 6 months, 12 months, 18 months ]
    Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.
  • Number of Subjects With Fever That Received Correct Treatment [ Time Frame: 6 months, 12 months, 18 months ]
    The number of people with fever that report receiving correct treatment with regards to malaria (i.e., received an RDT test and took ACTs if the result was positive, or did not take ACTs if the test result was negative).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
  • Percent of all ACTs used that were taken by people with a malaria positive test. [ Time Frame: 18 months post-baseline ]
    The main secondary outcome is the percent of all ACTs used that were taken by people with a malaria positive test. While the outcome will be measured in three regularly spaced population-based cross-sectional surveys (6 months, 12 months, and 18 months post-baseline), this secondary endpoint will be evaluated at 18 months post-baseline. Additional information will be provided by the two other timepoints.
  • Percent of all ACTs used that were taken by people without a test [ Time Frame: 18 months post-baseline ]
    Percent of all ACTs used that were taken by people without a test. While the outcome will be measured in three regularly spaced population-based cross-sectional surveys (6 months, 12 months, and 18 months post-baseline), this secondary endpoint will be evaluated at 18 months post-baseline. Additional information will be provided by the two other timepoints.
  • Percent of those with a positive test who got an ACT [ Time Frame: 18 months post-baseline ]
    Percent of those with a positive test who got an ACT. While the outcome will be measured in three regularly spaced population-based cross-sectional surveys (6 months, 12 months, and 18 months post-baseline), this secondary endpoint will be evaluated at 18 months post-baseline. Additional information will be provided by the two other timepoints.
  • Percent of those with a negative test who got an ACT [ Time Frame: 18 months post-baseline ]
    Percent of those with a negative test who got an ACT. While the outcome will be measured in three regularly spaced population-based cross-sectional surveys (6 months, 12 months, and 18 months post-baseline), this secondary endpoint will be evaluated at 18 months post-baseline. Additional information will be provided by the two other timepoints.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)
Official Title  ICMJE Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Fever
  • Malaria
Intervention  ICMJE Behavioral: Malaria RDT & conditional voucher for ACT from retail sector
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
Study Arms  ICMJE
  • Experimental: Malaria RDT & conditional voucher
    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.
    Intervention: Behavioral: Malaria RDT & conditional voucher for ACT from retail sector
  • No Intervention: Comparison Arm
    Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2019)
40340
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2015)
95220
Actual Study Completion Date  ICMJE July 12, 2017
Actual Primary Completion Date May 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA

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

EXCLUSION CRITERIA

Intervention exclusion criteria:

  • 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.

Cross sectional survey exclusion criteria:

• Households not in the intervention or control arms

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02461628
Other Study ID Numbers  ICMJE Pro00063384
5R01AI110478 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Moi University
Investigators  ICMJE
Principal Investigator: Wendy O'Meara, PhD Duke University
PRS Account Duke University
Verification Date October 2019

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