An interventional study of Malaria RDT & conditional voucher for ACT from retail sector in Fever and Malaria, sponsored by Duke University. Completed at 1 site in Kenya. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-29.
Sponsored by Duke University · Not applicable, Interventional, and Health services research
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.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 40,340 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Intervention participation criteria:
Cross sectional survey participation criteria:
EXCLUSION CRITERIA
Intervention exclusion criteria:
Cross sectional survey exclusion criteria:
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
Individuals in the comparison arm will only receive standard community health volunteer (CHV) visits.
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
Number of Subjects With a Fever Who Receive a Malaria Test From Any Source
Time frame: 6 months, 12 months, 18 months
Number of Participants Using ACT Who Had a Positive Test
Time frame: 6 months, 12 months, 18 months
Number of Participants Using an ACT Who Did Not Have a Test
Time frame: 6 months, 12 months, 18 months
Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)
Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.
Time frame: 6 months, 12 months, 18 months
Number of Subjects With Fever That Received Correct Treatment
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
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.
| Milestone | Malaria RDT & Conditional Voucher | Comparison Arm |
|---|---|---|
| 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 |
| Withdrew: Refused to complete survey | 4 | 7 |
| Participants | Malaria RDT & Conditional Voucher | Comparison Arm |
|---|---|---|
| 6 Months | 384 | 402 |
| 12 Months | 443 | 391 |
| 18 months | 547 | 406 |
| Participants | Malaria RDT & Conditional Voucher | Comparison Arm |
|---|---|---|
| 6 Months | 234 | 305 |
| 12 Months | 280 | 286 |
| 18 months | 426 | 302 |
| Participants | Malaria RDT & Conditional Voucher | Comparison Arm |
|---|---|---|
| 6 Months | 252 | 237 |
| 12 Months | 260 | 363 |
| 18 months | 271 | 354 |
Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.
| Participants | Malaria RDT & Conditional Voucher | Comparison Arm |
|---|---|---|
| 6 Months | 338 | 352 |
| 12 Months | 376 | 391 |
| 18 months | 496 | 410 |
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).
| Participants | Malaria RDT & Conditional Voucher | Comparison Arm |
|---|---|---|
| 6 Months | 309 | 340 |
| 12 Months | 344 | 306 |
| 18 months | 462 | 321 |
Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Malaria RDT & Conditional Voucher | 0/3,729 (0%) | 0/3,729 (0%) | 0/3,729 (0%) |
| Comparison Arm | 0/3,625 (0%) | 0/3,625 (0%) | 0/3,625 (0%) |
All participants who completed the survey.
| Age, Customized(Participants) | Malaria RDT & Conditional Voucher | Comparison Arm | Total |
|---|---|---|---|
| Age — Under 5 years | 836 | 788 | 1624 |
| Age — 5 to 17 years | 1553 | 1480 | 3033 |
| Age — 18 years and above | 1340 | 1357 | 2697 |
| Age — Data missing | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Malaria RDT & Conditional Voucher | Comparison Arm | Total |
|---|---|---|---|
| Female | 2225 | 2198 | 4423 |
| Male | 1504 | 1427 | 2931 |
| Ethnicity (NIH/OMB)(Participants) | Malaria RDT & Conditional Voucher | Comparison Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 3729 | 3625 | 7354 |
| Race (NIH/OMB)(Participants) | Malaria RDT & Conditional Voucher | Comparison Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3729 | 3625 | 7354 |
| Region of Enrollment(Participants) | Malaria RDT & Conditional Voucher | Comparison Arm | Total |
|---|---|---|---|
| Kenya | 3729 | 3625 | 7354 |
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