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

Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02461628

Enrollment

40340

Registered

2015-06-03

Start date

2015-07-31

Completion date

2017-07-12

Last updated

2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Malaria

Keywords

Malaria, Antimalarial subsidy, Malaria rapid diagnostic test (RDT), Public-private partnership, Community health workers

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.

Interventions

BEHAVIORALMalaria 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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source	6 months, 12 months, 18 months

Secondary

Measure	Time frame	Description
Number of Participants Using ACT Who Had a Positive Test	6 months, 12 months, 18 months	—
Number of Participants Using an ACT Who Did Not Have a Test	6 months, 12 months, 18 months	—
Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)	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	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).

Countries

Kenya

Participant flow

Recruitment details

A total of 40340 participants signed consent. This is a cluster randomized trial with repeated measures; the repeated measures are independent cross-sectional samples of the population in each cluster. Participants at different time points are different participants who signed separate consent forms.

Pre-assignment details

After enrollment, 7365 participants with a fever who received a malaria test from any source were approached to complete the survey. Only those 7365 participants are considered Started. Baseline data collection occurred before randomization of clusters to the arms.

Participants by arm

Arm	Count
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 ACT at a reduced fixed price in the retail sector conditional on a positive test. 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	3,729
Comparison Arm Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.	3,625
Total	7,354

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Refused to complete survey	4	7

Baseline characteristics

Characteristic	Malaria RDT & Conditional Voucher	Total	Comparison Arm
Age, Customized Age 18 years and above	1340 Participants	2697 Participants	1357 Participants
Age, Customized Age 5 to 17 years	1553 Participants	3033 Participants	1480 Participants
Age, Customized Age Data missing	0 Participants	0 Participants	0 Participants
Age, Customized Age Under 5 years	836 Participants	1624 Participants	788 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3729 Participants	7354 Participants	3625 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3729 Participants	7354 Participants	3625 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Region of Enrollment Kenya	3729 Participants	7354 Participants	3625 Participants
Sex: Female, Male Female	2225 Participants	4423 Participants	2198 Participants
Sex: Female, Male Male	1504 Participants	2931 Participants	1427 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 3,729	0 / 3,625
other Total, other adverse events	0 / 3,729	0 / 3,625
serious Total, serious adverse events	0 / 3,729	0 / 3,625