Trial Outcomes & Findings for Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: TESTsmART Aim 2 - Nigeria (NCT NCT04428385)
NCT ID: NCT04428385
Last Updated: 2024-05-06
Results Overview
The number of all ACTs that are sold to malaria test-positive clients.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2205 participants
Primary outcome timeframe
Day of enrollment
Results posted on
2024-05-06
Participant Flow
Unit of analysis: Private Medicine Retailers
Participant milestones
| Measure |
Arm 1 (Control)
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Consumer-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
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
|---|---|---|
|
Overall Study
STARTED
|
1101 24
|
1104 24
|
|
Overall Study
COMPLETED
|
1101 24
|
1104 24
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age missing for 3 participants in Arm 2.
Baseline characteristics by cohort
| Measure |
Arm 1 (Control)
n=1101 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Consumer-directed and Provider-directed Intervention)
n=1104 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
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
Total
n=2205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Under 18
|
175 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
213 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
388 Participants
n=2202 Participants • Age missing for 3 participants in Arm 2.
|
|
Age, Customized
18-25
|
178 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
173 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
351 Participants
n=2202 Participants • Age missing for 3 participants in Arm 2.
|
|
Age, Customized
26-39
|
404 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
414 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
818 Participants
n=2202 Participants • Age missing for 3 participants in Arm 2.
|
|
Age, Customized
40-59
|
307 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
258 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
565 Participants
n=2202 Participants • Age missing for 3 participants in Arm 2.
|
|
Age, Customized
60 -79
|
34 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
40 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
74 Participants
n=2202 Participants • Age missing for 3 participants in Arm 2.
|
|
Age, Customized
80+
|
3 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
3 Participants
n=1101 Participants • Age missing for 3 participants in Arm 2.
|
6 Participants
n=2202 Participants • Age missing for 3 participants in Arm 2.
|
|
Sex: Female, Male
Female
|
508 Participants
n=1101 Participants • Gender missing for 2 participants in Arm 2.
|
560 Participants
n=1102 Participants • Gender missing for 2 participants in Arm 2.
|
1068 Participants
n=2203 Participants • Gender missing for 2 participants in Arm 2.
|
|
Sex: Female, Male
Male
|
593 Participants
n=1101 Participants • Gender missing for 2 participants in Arm 2.
|
542 Participants
n=1102 Participants • Gender missing for 2 participants in Arm 2.
|
1135 Participants
n=2203 Participants • Gender missing for 2 participants in Arm 2.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1101 Participants
|
0 Participants
n=1104 Participants
|
0 Participants
n=2205 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1101 Participants
n=1101 Participants
|
1104 Participants
n=1104 Participants
|
2205 Participants
n=2205 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1101 Participants
|
0 Participants
n=1104 Participants
|
0 Participants
n=2205 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1101 Participants
|
0 Participants
n=1104 Participants
|
0 Participants
n=2205 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1101 Participants
|
0 Participants
n=1104 Participants
|
0 Participants
n=2205 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1101 Participants
|
0 Participants
n=1104 Participants
|
0 Participants
n=2205 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1101 Participants
n=1101 Participants
|
1104 Participants
n=1104 Participants
|
2205 Participants
n=2205 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=1101 Participants
|
0 Participants
n=1104 Participants
|
0 Participants
n=2205 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1101 Participants
|
0 Participants
n=1104 Participants
|
0 Participants
n=2205 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1101 Participants
|
0 Participants
n=1104 Participants
|
0 Participants
n=2205 Participants
|
|
Region of Enrollment
Nigeria
|
1101 Participants
n=1101 Participants
|
1104 Participants
n=1104 Participants
|
2205 Participants
n=2205 Participants
|
PRIMARY outcome
Timeframe: Day of enrollmentPopulation: Only participants who purchased ACTs were included in this analysis. Malaria test-positivity was based on mRDT testing testing at the outlet or documented testing brought to the facility.
The number of all ACTs that are sold to malaria test-positive clients.
Outcome measures
| Measure |
Arm 1 (Control)
n=558 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Consumer-directed and Provider-directed Intervention)
n=626 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
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
|---|---|---|
|
ACT (Artemisinin Combination Therapy) Consumption by True Malaria Cases
|
49 ACTs
|
49 ACTs
|
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 suspected malaria cases presenting to the retail outlet that are tested.
Outcome measures
| Measure |
Arm 1 (Control)
n=928 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Consumer-directed and Provider-directed Intervention)
n=958 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
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
|---|---|---|
|
Use of Malaria Rapid Diagnostic Test
|
226 suspected malaria cases
|
217 suspected malaria cases
|
SECONDARY outcome
Timeframe: Day of enrollmentPopulation: Only participants who tested at the outlet are included.
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=226 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Consumer-directed and Provider-directed Intervention)
n=217 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
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
|---|---|---|
|
Adherence to the RDT Result Among All Those Tested in the Shop
|
167 Participants
|
118 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 suspected malaria cases that are managed appropriately (tested for malaria, use ACT following a positive test, and do not purchase an ACT after a negative test).
Outcome measures
| Measure |
Arm 1 (Control)
n=928 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Consumer-directed and Provider-directed Intervention)
n=958 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
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
|---|---|---|
|
Appropriate Case Management
|
167 suspected malaria cases
|
118 suspected malaria cases
|
SECONDARY outcome
Timeframe: Day of enrollmentPopulation: Only untested participants are included.
Number of participants who are not tested for malaria (did not test in the shop or have documentation of a test) and purchased an ACT.
Outcome measures
| Measure |
Arm 1 (Control)
n=836 Participants
RDTs available at study-recommended price, providers trained on mobile reporting app
|
Arm 2 (Consumer-directed and Provider-directed Intervention)
n=827 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
Testing incentive: A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
Conditional artemisinin combination therapy subsidy: An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
|
|---|---|---|
|
ACT (Artemisinin Combination Therapy) Use Among Untested Participants
|
462 Participants
|
498 Participants
|
Adverse Events
Arm 1 (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 (Consumer-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