Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT02461628
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH), Moi University (Other)
40,340
1
2
24.4
1654.8

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Malaria RDT & conditional voucher for ACT from retail sector
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40340 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
May 26, 2017
Actual Study Completion Date :
Jul 12, 2017

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

  1. Number of Subjects With a Fever Who Receive a Malaria Test From Any Source [6 months, 12 months, 18 months]

Secondary Outcome Measures

  1. Number of Participants Using ACT Who Had a Positive Test [6 months, 12 months, 18 months]

  2. Number of Participants Using an ACT Who Did Not Have a Test [6 months, 12 months, 18 months]

  3. 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.

  4. 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

Ages Eligible for Study:
1 Year and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT02461628
Other Study ID Numbers:
  • Pro00063384
  • 5R01AI110478
First Posted:
Jun 3, 2015
Last Update Posted:
Oct 29, 2019
Last Verified:
Oct 1, 2019

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

1. Primary Outcome
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%
2. Secondary Outcome
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%
3. Secondary Outcome
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%
4. Secondary Outcome
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%
5. Secondary Outcome
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

[Not Specified]

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
Email wpo@duke.edu
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT02461628
Other Study ID Numbers:
  • Pro00063384
  • 5R01AI110478
First Posted:
Jun 3, 2015
Last Update Posted:
Oct 29, 2019
Last Verified:
Oct 1, 2019