Trial Outcomes & Findings for Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial AIM 1 (NCT NCT03810014)
NCT ID: NCT03810014
Last Updated: 2020-11-12
Results Overview
This outcome will be evaluated once for each customer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
842 participants
Primary outcome timeframe
At the end of a participant's visit to participating retail outlet, up to 1 hour
Results posted on
2020-11-12
Participant Flow
The study was carried out in a random sample of twelve retail outlets in two sub-counties of rural western Kenya. Potential participants were approached by the research assistants as they sought services at the outlets. Participants were then offered a scratch card with masked arm assignment, which randomized them to one of four study arms in a 1:1:1:1 ratio, each arm with a different combination of two different RDT prices and two different conditional ACT prices using a 2x2 factorial design.
Participant milestones
| Measure |
Arm 1
The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
|
Arm 2
The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
|
Arm 3
The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
|
Arm 4
The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
215
|
204
|
210
|
213
|
|
Overall Study
COMPLETED
|
213
|
202
|
210
|
211
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
Arm 1
The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
|
Arm 2
The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
|
Arm 3
The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
|
Arm 4
The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
|
|---|---|---|---|---|
|
Overall Study
Pregnancy
|
2
|
2
|
0
|
2
|
Baseline Characteristics
Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial AIM 1
Baseline characteristics by cohort
| Measure |
Arm 1
n=213 Participants
The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
|
Arm 2
n=202 Participants
The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
|
Arm 3
n=210 Participants
The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
|
Arm 4
n=211 Participants
The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
|
Total
n=836 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30 years
n=5 Participants
|
28.5 years
n=7 Participants
|
30 years
n=5 Participants
|
31 years
n=4 Participants
|
30 years
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
97 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
388 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
116 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
447 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
213 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
836 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
213 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
836 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Kenya
|
213 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
836 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At the end of a participant's visit to participating retail outlet, up to 1 hourThis outcome will be evaluated once for each customer
Outcome measures
| Measure |
Arm 1
n=213 Participants
The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
|
Arm 2
n=202 Participants
The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
|
Arm 3
n=210 Participants
The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
|
Arm 4
n=211 Participants
The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
|
|---|---|---|---|---|
|
Number of Participants That Purchase an mRDT (Malaria Rapid Diagnostic Test)
|
205 Participants
|
195 Participants
|
207 Participants
|
211 Participants
|
SECONDARY outcome
Timeframe: At the end of a participant's visit to participating retail outlet, up to 1 hourPopulation: Participants with a positive mRDT
Outcome measures
| Measure |
Arm 1
n=51 Participants
The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
|
Arm 2
n=46 Participants
The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
|
Arm 3
n=31 Participants
The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
|
Arm 4
n=46 Participants
The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
|
|---|---|---|---|---|
|
Number of Participants With a Positive mRDT That Purchased an ACT (Artemisinin-based Combination Therapy)
|
47 Participants
|
39 Participants
|
24 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: At the end of a participant's visit to participating retail outlet, up to 1 hourPopulation: Participants with a negative mRDT. 5 participants were not included due to missing ACT purchasing behavior; four in Arm 2 and one in Arm 3.
Outcome measures
| Measure |
Arm 1
n=154 Participants
The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
|
Arm 2
n=145 Participants
The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
|
Arm 3
n=175 Participants
The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
|
Arm 4
n=165 Participants
The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
|
|---|---|---|---|---|
|
Number of Participants With a Negative mRDT That Did Not Purchase an ACT
|
144 Participants
|
132 Participants
|
166 Participants
|
155 Participants
|
SECONDARY outcome
Timeframe: At the end of a participant's visit to participating retail outlet, up to 1 hourPopulation: Participants with no mRDT
Outcome measures
| Measure |
Arm 1
n=8 Participants
The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
|
Arm 2
n=7 Participants
The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
|
Arm 3
n=3 Participants
The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
|
Arm 4
The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
|
|---|---|---|---|---|
|
Number of Participants That Did Not Purchase an mRDT and Did Not Purchase an ACT
|
4 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 4
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