Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)
Study Details
Study Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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 artemisinin combination therapy (ACT) at a reduced fixed price in the retail sector conditional on a positive test. |
Behavioral: 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
|
No Intervention: Comparison Arm Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
Outcome Measures
Primary Outcome Measures
- Number of Subjects With a Fever Who Receive a Malaria Test From Any Source [6 months, 12 months, 18 months]
Secondary Outcome Measures
- 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).
Eligibility Criteria
Criteria
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 exclusion criteria:
-
Client has signs of severe disease or other problem requiring immediate referral to a health facility
-
Client has already visited a health facility, taken or purchased antimalarials for the current illness.
Cross sectional survey exclusion criteria:
• Households not in the intervention or control arms
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Moi University | Eldoret | Kenya |
Sponsors and Collaborators
- Duke University
- National Institute of Allergy and Infectious Diseases (NIAID)
- Moi University
Investigators
- Principal Investigator: Wendy O'Meara, PhD, Duke University
Study Documents (Full-Text)
More Information
Publications
None provided.- Pro00063384
- 5R01AI110478
Study Results
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 Detail | 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. |
Arm/Group Title | Malaria RDT & Conditional Voucher | Comparison Arm |
---|---|---|
Arm/Group Description | 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 | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
Period Title: Overall Study | ||
STARTED | 3733 | 3632 |
Baseline Survey | 1038 | 974 |
6 Month Survey | 814 | 832 |
12 Month Survey | 882 | 914 |
18 Month Survey | 995 | 905 |
COMPLETED | 3729 | 3625 |
NOT COMPLETED | 4 | 7 |
Baseline Characteristics
Arm/Group Title | Malaria RDT & Conditional Voucher | Comparison Arm | Total |
---|---|---|---|
Arm/Group Description | 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 | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. | Total of all reporting groups |
Overall Participants | 3729 | 3625 | 7354 |
Age, Customized (Count of Participants) | |||
Under 5 years |
836
22.4%
|
788
21.7%
|
1624
22.1%
|
5 to 17 years |
1553
41.6%
|
1480
40.8%
|
3033
41.2%
|
18 years and above |
1340
35.9%
|
1357
37.4%
|
2697
36.7%
|
Data missing |
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||
Female |
2225
59.7%
|
2198
60.6%
|
4423
60.1%
|
Male |
1504
40.3%
|
1427
39.4%
|
2931
39.9%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
Not Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
3729
100%
|
3625
100%
|
7354
100%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
White |
0
0%
|
0
0%
|
0
0%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
3729
100%
|
3625
100%
|
7354
100%
|
Region of Enrollment (Count of Participants) | |||
Kenya |
3729
100%
|
3625
100%
|
7354
100%
|
Outcome Measures
Title | Number of Subjects With a Fever Who Receive a Malaria Test From Any Source |
---|---|
Description | |
Time Frame | 6 months, 12 months, 18 months |
Outcome Measure Data
Analysis Population Description |
---|
Subjects with fever who completed the survey at 6, 12, or 18 months. |
Arm/Group Title | Malaria RDT & Conditional Voucher | Comparison Arm |
---|---|---|
Arm/Group Description | 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 | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
Measure Participants | 2594 | 2573 |
6 Months |
384
10.3%
|
402
11.1%
|
12 Months |
443
11.9%
|
391
10.8%
|
18 months |
547
14.7%
|
406
11.2%
|
Title | Number of Participants Using ACT Who Had a Positive Test |
---|---|
Description | |
Time Frame | 6 months, 12 months, 18 months |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who took AL and who completed the survey at 6, 12, or 18 months. |
Arm/Group Title | Malaria RDT & Conditional Voucher | Comparison Arm |
---|---|---|
Arm/Group Description | 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 | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
Measure Participants | 1865 | 1939 |
6 Months |
234
6.3%
|
305
8.4%
|
12 Months |
280
7.5%
|
286
7.9%
|
18 months |
426
11.4%
|
302
8.3%
|
Title | Number of Participants Using an ACT Who Did Not Have a Test |
---|---|
Description | |
Time Frame | 6 months, 12 months, 18 months |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who took AL and who completed the survey at 6, 12, or 18 months. |
Arm/Group Title | Malaria RDT & Conditional Voucher | Comparison Arm |
---|---|---|
Arm/Group Description | 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 | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
Measure Participants | 1865 | 1939 |
6 Months |
252
6.8%
|
237
6.5%
|
12 Months |
260
7%
|
363
10%
|
18 months |
271
7.3%
|
354
9.8%
|
Title | Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine) |
---|---|
Description | Denominator is all those who took AL. Artemether lumefantrine is one type of ACT. |
Time Frame | 6 months, 12 months, 18 months |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who received AL and completed the survey at 6, 12, or 18 months. |
Arm/Group Title | Malaria RDT & Conditional Voucher | Comparison Arm |
---|---|---|
Arm/Group Description | 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 | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
Measure Participants | 1783 | 1832 |
6 Months |
338
9.1%
|
352
9.7%
|
12 Months |
376
10.1%
|
391
10.8%
|
18 months |
496
13.3%
|
410
11.3%
|
Title | Number of Subjects With Fever That Received Correct Treatment |
---|---|
Description | 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). |
Time Frame | 6 months, 12 months, 18 months |
Outcome Measure Data
Analysis Population Description |
---|
Subjects with fever who completed the survey at 6, 12, or 18 months. |
Arm/Group Title | Malaria RDT & Conditional Voucher | Comparison Arm |
---|---|---|
Arm/Group Description | 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 | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. |
Measure Participants | 2594 | 2573 |
6 Months |
309
8.3%
|
340
9.4%
|
12 Months |
344
9.2%
|
306
8.4%
|
18 months |
462
12.4%
|
321
8.9%
|
Adverse Events
Time Frame | 18 months | |||
---|---|---|---|---|
Adverse Event Reporting Description | Adverse event data were collected on subjects who completed the survey at baseline, 6, 12, or 18 months. | |||
Arm/Group Title | Malaria RDT & Conditional Voucher | Comparison Arm | ||
Arm/Group Description | 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 | Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits. | ||
All Cause Mortality |
||||
Malaria RDT & Conditional Voucher | Comparison Arm | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3729 (0%) | 0/3625 (0%) | ||
Serious Adverse Events |
||||
Malaria RDT & Conditional Voucher | Comparison Arm | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3729 (0%) | 0/3625 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Malaria RDT & Conditional Voucher | Comparison Arm | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3729 (0%) | 0/3625 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Wendy O'Meara, PhD |
---|---|
Organization | Duke University |
Phone | 16099103091 |
wpo@duke.edu |
- Pro00063384
- 5R01AI110478