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

Malaria Clinical Trial

Official title:

Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461628
• Other study ID #: Pro00063384
• Secondary ID: 5R01AI110478
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 12, 2017

Study information

• Verified date: October 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40340
• Est. completion date: July 12, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Malaria

Intervention

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

Locations

Country	Name	City	State
Kenya	Moi University	Eldoret

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Moi University, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With a Fever Who Receive a Malaria Test From Any Source		6 months, 12 months, 18 months
Secondary	Number of Participants Using ACT Who Had a Positive Test		6 months, 12 months, 18 months
Secondary	Number of Participants Using an ACT Who Did Not Have a Test		6 months, 12 months, 18 months
Secondary	Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)	Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.	6 months, 12 months, 18 months
Secondary	Number of Subjects With Fever That Received Correct Treatment	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).	6 months, 12 months, 18 months