Malaria Clinical Trial
Official title:
Sustainable Financial Incentives To Improve Prescription Practices For Malaria
This project aims to test an innovative, sustainable financial incentive designed to reduce the number of non-malarial fevers that are treated inappropriately with antimalarial drugs.
Global investments in controlling malaria have led to some exciting reductions in the burden
of malaria. In some areas, malaria-related deaths have dropped by more than 90%. As malaria
transmission declines, a greater fraction of pediatric fevers are from other causes.
However, these fevers continue to be treated as malaria, often despite the availability of
diagnostic testing. In a typical rural health facility in Kenya, more than 90% of febrile
patients are prescribed an antimalarial when no diagnostic tests are available. Even when
microscopy or rapid diagnostic tests (RDTs) are available, between 50-80% of patients with a
negative test are nonetheless prescribed antimalarials. Inappropriately treated fevers in
children can lead to serious consequences for the patient and can accelerate the spread of
drug resistance. In addition to the risk to patients, overuse of antimalarials also puts a
financial strain on the government health system. Although there is considerable incentive
for governments to reduce drug costs and wastage, the financial pressure is not experienced
at the appropriate levels of decision-making.
This project aims to test an innovative, sustainable financial incentive designed to reduce
the number of non-malarial fevers that are treated inappropriately with antimalarial drugs.
The study team will test a financial incentive targeted at the health facility to determine
if it improves adherence to diagnostic results and clinical protocols. Eighteen rural health
facilities in Western Kenya will be enrolled and randomly allocated to one of two arms. The
study team will compare the effectiveness of clinical and technical training in diagnosis of
malaria alone (Arm 1) to training plus financial incentives linked to prescription practices
(Arm 2) in improving diagnosis and treatment of malaria and non-malaria fevers. The practice
of prescribing antimalarials to patients with a negative diagnostic will be compared between
facilities with and without the incentive structure. Secondary outcomes will include
sensitivity and specificity of routine microscopy at health centers, use of alternative
treatments for slide negative fevers, and frequency of stock-outs of antimalarial drugs.
This project will tackle an important implementation research problem. It seeks to test
solutions to the problem of poor adherence to evidence-based clinical guidelines for malaria
treatment, and thereby reduce inappropriate antimalarial drug use and drug wastage. This
project will be conducted in collaboration with Kenya's Division of Malaria Control and
avenues to roll-out the intervention, if successful, will be actively explored.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04601714 -
Baseline Cohort Malaria Morbidity Study
|
||
| Withdrawn |
NCT04020653 -
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
|
Phase 2 | |
| Terminated |
NCT04368910 -
Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
|
Phase 3 | |
| Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
| Completed |
NCT02544048 -
Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
|
||
| Completed |
NCT00527163 -
Role of Nitric Oxide in Malaria
|
||
| Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
| Active, not recruiting |
NCT04704674 -
Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
|
||
| Completed |
NCT03276962 -
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
|
Phase 2 | |
| Completed |
NCT04966871 -
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
|
Phase 1 | |
| Completed |
NCT00289185 -
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
|
Phase 2 | |
| Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
| Active, not recruiting |
NCT06153862 -
Africa Ready Malaria Screening
|
N/A | |
| Completed |
NCT04545905 -
Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
|
||
| Recruiting |
NCT06278181 -
Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
|
||
| Completed |
NCT02909712 -
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
|
Phase 2 | |
| Withdrawn |
NCT02793414 -
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
|
||
| Completed |
NCT02793622 -
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
|
Phase 3 | |
| Withdrawn |
NCT02793388 -
A Trial on Supervised Primaquine Use in Ethiopia
|
Phase 4 | |
| Completed |
NCT02527005 -
A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
|
Phase 1 |