Trial Outcomes & Findings for Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: TESTsmART Aim 2 - Kenya (NCT NCT04428307)
NCT ID: NCT04428307
Last Updated: 2024-02-20
Results Overview
Number of participants who purchased ACTs and were malaria test-positive. Malaria test-positivity was based on mRDT testing testing at the outlet or documented testing brought to the facility.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5696 participants
Primary outcome timeframe
Day of enrollment
Results posted on
2024-02-20
Participant Flow
Recruitment took place between Jan 2021 and August 2022, with customers leaving participating outlets screened for study eligibility by trained exit interviewers.
Participating shops were randomly assigned to each arm of the study, with the exception of 2 pairs of shops that were within visual distance of each other and therefore assigned to the same study arm.
Unit of analysis: Retail medicine outlets
Participant milestones
| Measure |
Arm 1 (Control)
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Client-directed Intervention)
ACT subsidy to client conditional on positive RDT, RDTs available at study-recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
Arm 3 (Client-directed and Provider-directed Intervention)
providers receive a small payment for each RDT that they perform and consumers with a positive test are eligible for a subsidy on a quality-assured ACT, RDTs are available at study recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1692 13
|
1789 13
|
2215 13
|
|
Overall Study
COMPLETED
|
1692 13
|
1789 13
|
2214 13
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
1 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gender missing for 1 participant in Arm 2 and 4 participants in Arm 3.
Baseline characteristics by cohort
| Measure |
Arm 1 (Control)
n=1692 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Client-directed Intervention)
n=1789 Participants
ACT subsidy to client conditional on positive RDT, RDTs available at study-recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
Arm 3 (Client-directed and Provider-directed Intervention)
n=2214 Participants
providers receive a small payment for each RDT that they perform and consumers with a positive test are eligible for a subsidy on a quality-assured ACT, RDTs are available at study recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
|
Total
n=5695 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age in years · 18-25
|
264 Participants
n=1692 Participants
|
263 Participants
n=1789 Participants
|
314 Participants
n=2214 Participants
|
841 Participants
n=5695 Participants
|
|
Age, Customized
Age in years · 26-39
|
672 Participants
n=1692 Participants
|
719 Participants
n=1789 Participants
|
922 Participants
n=2214 Participants
|
2313 Participants
n=5695 Participants
|
|
Age, Customized
Age in years · 40-59
|
579 Participants
n=1692 Participants
|
622 Participants
n=1789 Participants
|
766 Participants
n=2214 Participants
|
1967 Participants
n=5695 Participants
|
|
Age, Customized
Age in years · 60-79
|
160 Participants
n=1692 Participants
|
167 Participants
n=1789 Participants
|
196 Participants
n=2214 Participants
|
523 Participants
n=5695 Participants
|
|
Age, Customized
Age in years · 80+
|
13 Participants
n=1692 Participants
|
15 Participants
n=1789 Participants
|
10 Participants
n=2214 Participants
|
38 Participants
n=5695 Participants
|
|
Age, Customized
Age in years · Unknown
|
4 Participants
n=1692 Participants
|
3 Participants
n=1789 Participants
|
6 Participants
n=2214 Participants
|
13 Participants
n=5695 Participants
|
|
Sex: Female, Male
Female
|
939 Participants
n=1692 Participants • Gender missing for 1 participant in Arm 2 and 4 participants in Arm 3.
|
968 Participants
n=1788 Participants • Gender missing for 1 participant in Arm 2 and 4 participants in Arm 3.
|
1262 Participants
n=2210 Participants • Gender missing for 1 participant in Arm 2 and 4 participants in Arm 3.
|
3169 Participants
n=5690 Participants • Gender missing for 1 participant in Arm 2 and 4 participants in Arm 3.
|
|
Sex: Female, Male
Male
|
753 Participants
n=1692 Participants • Gender missing for 1 participant in Arm 2 and 4 participants in Arm 3.
|
820 Participants
n=1788 Participants • Gender missing for 1 participant in Arm 2 and 4 participants in Arm 3.
|
948 Participants
n=2210 Participants • Gender missing for 1 participant in Arm 2 and 4 participants in Arm 3.
|
2521 Participants
n=5690 Participants • Gender missing for 1 participant in Arm 2 and 4 participants in Arm 3.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1692 Participants
|
0 Participants
n=1789 Participants
|
0 Participants
n=2214 Participants
|
0 Participants
n=5695 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1692 Participants
n=1692 Participants
|
1789 Participants
n=1789 Participants
|
2214 Participants
n=2214 Participants
|
5695 Participants
n=5695 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1692 Participants
|
0 Participants
n=1789 Participants
|
0 Participants
n=2214 Participants
|
0 Participants
n=5695 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1692 Participants
|
0 Participants
n=1789 Participants
|
0 Participants
n=2214 Participants
|
0 Participants
n=5695 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1692 Participants
|
0 Participants
n=1789 Participants
|
0 Participants
n=2214 Participants
|
0 Participants
n=5695 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1692 Participants
|
0 Participants
n=1789 Participants
|
0 Participants
n=2214 Participants
|
0 Participants
n=5695 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1692 Participants
n=1692 Participants
|
1789 Participants
n=1789 Participants
|
2214 Participants
n=2214 Participants
|
5695 Participants
n=5695 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=1692 Participants
|
0 Participants
n=1789 Participants
|
0 Participants
n=2214 Participants
|
0 Participants
n=5695 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1692 Participants
|
0 Participants
n=1789 Participants
|
0 Participants
n=2214 Participants
|
0 Participants
n=5695 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1692 Participants
|
0 Participants
n=1789 Participants
|
0 Participants
n=2214 Participants
|
0 Participants
n=5695 Participants
|
|
Region of Enrollment
Kenya
|
1692 Participants
n=1692 Participants
|
1789 Participants
n=1789 Participants
|
2214 Participants
n=2214 Participants
|
5695 Participants
n=5695 Participants
|
PRIMARY outcome
Timeframe: Day of enrollmentPopulation: Participants who purchased ACTs.
Number of participants who purchased ACTs and were malaria test-positive. Malaria test-positivity was based on mRDT testing testing at the outlet or documented testing brought to the facility.
Outcome measures
| Measure |
Arm 1 (Control)
n=1039 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Client-directed Intervention)
n=1004 Participants
ACT subsidy to client conditional on positive RDT, RDTs available at study-recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
Arm 3 (Client-directed and Provider-directed Intervention)
n=1293 Participants
providers receive a small payment for each RDT that they perform and consumers with a positive test are eligible for a subsidy on a quality-assured ACT, RDTs are available at study recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
|
|---|---|---|---|
|
ACT (Artemisinin Combination Therapy) Consumption by True Malaria Cases
|
313 Participants
|
250 Participants
|
339 Participants
|
SECONDARY outcome
Timeframe: Day of enrollmentPopulation: Only participants who were suspected of having malaria were included in this analysis. This included anyone who tested for malaria or purchased antimalarials without a test.
Number of participants with suspected malaria cases presenting to the retail outlet that are tested.
Outcome measures
| Measure |
Arm 1 (Control)
n=1541 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Client-directed Intervention)
n=1576 Participants
ACT subsidy to client conditional on positive RDT, RDTs available at study-recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
Arm 3 (Client-directed and Provider-directed Intervention)
n=1878 Participants
providers receive a small payment for each RDT that they perform and consumers with a positive test are eligible for a subsidy on a quality-assured ACT, RDTs are available at study recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
|
|---|---|---|---|
|
Use of Malaria Rapid Diagnostic Test
|
819 Participants
|
804 Participants
|
813 Participants
|
SECONDARY outcome
Timeframe: Day of enrollmentPopulation: Participants who tested at the outlet.
The number of tested participants who are adherent where adherence to the test result is defined as taking a quality-assured ACT if the RDT is positive or taking another drug (or no drug) if the test is negative.
Outcome measures
| Measure |
Arm 1 (Control)
n=819 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Client-directed Intervention)
n=804 Participants
ACT subsidy to client conditional on positive RDT, RDTs available at study-recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
Arm 3 (Client-directed and Provider-directed Intervention)
n=813 Participants
providers receive a small payment for each RDT that they perform and consumers with a positive test are eligible for a subsidy on a quality-assured ACT, RDTs are available at study recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
|
|---|---|---|---|
|
Adherence to the RDT (Rapid Diagnostic Test) Result Among All Those Tested in the Shop
|
558 Participants
|
595 Participants
|
591 Participants
|
SECONDARY outcome
Timeframe: Day of enrollmentPopulation: Only participants who were suspected of having malaria were included in this analysis. This included anyone who tested for malaria or purchased antimalarials without a test.
Number of all participants with suspected malaria cases that are managed appropriately (tested for malaria, and use ACT following a positive test and do not purchase an ACT after a negative test)
Outcome measures
| Measure |
Arm 1 (Control)
n=1541 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Client-directed Intervention)
n=1576 Participants
ACT subsidy to client conditional on positive RDT, RDTs available at study-recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
Arm 3 (Client-directed and Provider-directed Intervention)
n=1878 Participants
providers receive a small payment for each RDT that they perform and consumers with a positive test are eligible for a subsidy on a quality-assured ACT, RDTs are available at study recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
|
|---|---|---|---|
|
Appropriate Case Management
|
558 Participants
|
595 Participants
|
591 Participants
|
SECONDARY outcome
Timeframe: Day of enrollmentPopulation: Only participants who purchased any antimalarial without documented test results available were included in this analysis.
Number of participants who are not tested for malaria and purchased an ACT, among those who did not test in the shop, do not have documentation of a test, and purchased any antimalarial at the shop.
Outcome measures
| Measure |
Arm 1 (Control)
n=676 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Client-directed Intervention)
n=746 Participants
ACT subsidy to client conditional on positive RDT, RDTs available at study-recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
Arm 3 (Client-directed and Provider-directed Intervention)
n=798 Participants
providers receive a small payment for each RDT that they perform and consumers with a positive test are eligible for a subsidy on a quality-assured ACT, RDTs are available at study recommended price
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
|
|---|---|---|---|
|
ACT (Artemisinin Combination Therapy) Use Among Untested Clients
|
523 Participants
|
542 Participants
|
601 Participants
|
Adverse Events
Arm 1 (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 (Client-directed Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3 (Client-directed and Provider-directed Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place