Skip to main content
OpenTrials
Completed

NCT Number: NCT02461628

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moi University

Eldoret, Kenya

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Malaria RDT & conditional voucher for ACT from retail sector

Behavioral

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

Primary outcomes

  1. Number of Subjects With a Fever Who Receive a Malaria Test From Any Source

    Time frame: 6 months, 12 months, 18 months

Secondary outcomes

  1. Number of Participants Using ACT Who Had a Positive Test

    Time frame: 6 months, 12 months, 18 months

  2. Number of Participants Using an ACT Who Did Not Have a Test

    Time frame: 6 months, 12 months, 18 months

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Moi University
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 3, 2015
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.