Trial Outcomes & Findings for Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2) (NCT NCT02461628)
NCT ID: NCT02461628
Last Updated: 2019-10-29
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40340 participants
Primary outcome timeframe
6 months, 12 months, 18 months
Results posted on
2019-10-29
Participant Flow
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.
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.
Unit of analysis: Community Units
Participant milestones
| Measure |
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
|
Comparison Arm
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
|
|---|---|---|
|
Overall Study
STARTED
|
3733 16
|
3632 16
|
|
Overall Study
Baseline Survey
|
1038 16
|
974 16
|
|
Overall Study
6 Month Survey
|
814 16
|
832 16
|
|
Overall Study
12 Month Survey
|
882 16
|
914 16
|
|
Overall Study
18 Month Survey
|
995 16
|
905 16
|
|
Overall Study
COMPLETED
|
3729 16
|
3625 16
|
|
Overall Study
NOT COMPLETED
|
4 0
|
7 0
|
Reasons for withdrawal
| Measure |
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
|
Comparison Arm
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
|
|---|---|---|
|
Overall Study
Refused to complete survey
|
4
|
7
|
Baseline Characteristics
Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)
Baseline characteristics by cohort
| Measure |
Malaria RDT & Conditional Voucher
n=3729 Participants
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
|
Comparison Arm
n=3625 Participants
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
|
Total
n=7354 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · Under 5 years
|
836 Participants
n=99 Participants
|
788 Participants
n=107 Participants
|
1624 Participants
n=206 Participants
|
|
Age, Customized
Age · 5 to 17 years
|
1553 Participants
n=99 Participants
|
1480 Participants
n=107 Participants
|
3033 Participants
n=206 Participants
|
|
Age, Customized
Age · 18 years and above
|
1340 Participants
n=99 Participants
|
1357 Participants
n=107 Participants
|
2697 Participants
n=206 Participants
|
|
Age, Customized
Age · Data missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2225 Participants
n=99 Participants
|
2198 Participants
n=107 Participants
|
4423 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1504 Participants
n=99 Participants
|
1427 Participants
n=107 Participants
|
2931 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3729 Participants
n=99 Participants
|
3625 Participants
n=107 Participants
|
7354 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3729 Participants
n=99 Participants
|
3625 Participants
n=107 Participants
|
7354 Participants
n=206 Participants
|
|
Region of Enrollment
Kenya
|
3729 Participants
n=99 Participants
|
3625 Participants
n=107 Participants
|
7354 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months, 12 months, 18 monthsPopulation: Subjects with fever who completed the survey at 6, 12, or 18 months.
Outcome measures
| Measure |
Malaria RDT & Conditional Voucher
n=2594 Participants
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
|
Comparison Arm
n=2573 Participants
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
|
|---|---|---|
|
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source
6 Months
|
384 Participants
|
402 Participants
|
|
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source
12 Months
|
443 Participants
|
391 Participants
|
|
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source
18 months
|
547 Participants
|
406 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 monthsPopulation: Subjects who took AL and who completed the survey at 6, 12, or 18 months.
Outcome measures
| Measure |
Malaria RDT & Conditional Voucher
n=1865 Participants
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
|
Comparison Arm
n=1939 Participants
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
|
|---|---|---|
|
Number of Participants Using ACT Who Had a Positive Test
6 Months
|
234 Participants
|
305 Participants
|
|
Number of Participants Using ACT Who Had a Positive Test
12 Months
|
280 Participants
|
286 Participants
|
|
Number of Participants Using ACT Who Had a Positive Test
18 months
|
426 Participants
|
302 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 monthsPopulation: Subjects who took AL and who completed the survey at 6, 12, or 18 months.
Outcome measures
| Measure |
Malaria RDT & Conditional Voucher
n=1865 Participants
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
|
Comparison Arm
n=1939 Participants
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
|
|---|---|---|
|
Number of Participants Using an ACT Who Did Not Have a Test
6 Months
|
252 Participants
|
237 Participants
|
|
Number of Participants Using an ACT Who Did Not Have a Test
12 Months
|
260 Participants
|
363 Participants
|
|
Number of Participants Using an ACT Who Did Not Have a Test
18 months
|
271 Participants
|
354 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 monthsPopulation: Subjects who received AL and completed the survey at 6, 12, or 18 months.
Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.
Outcome measures
| Measure |
Malaria RDT & Conditional Voucher
n=1783 Participants
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
|
Comparison Arm
n=1832 Participants
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
|
|---|---|---|
|
Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)
6 Months
|
338 Participants
|
352 Participants
|
|
Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)
12 Months
|
376 Participants
|
391 Participants
|
|
Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)
18 months
|
496 Participants
|
410 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 monthsPopulation: Subjects with fever who completed the survey at 6, 12, or 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).
Outcome measures
| Measure |
Malaria RDT & Conditional Voucher
n=2594 Participants
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
|
Comparison Arm
n=2573 Participants
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
|
|---|---|---|
|
Number of Subjects With Fever That Received Correct Treatment
6 Months
|
309 Participants
|
340 Participants
|
|
Number of Subjects With Fever That Received Correct Treatment
12 Months
|
344 Participants
|
306 Participants
|
|
Number of Subjects With Fever That Received Correct Treatment
18 months
|
462 Participants
|
321 Participants
|
Adverse Events
Malaria RDT & Conditional Voucher
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparison Arm
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