Training in Fever Case Management With Rapid Diagnostic Tests (RDTs) for Malaria in Uganda

Malaria Clinical Trial

Official title:

Effectiveness and Safety of Training in Fever Case Management Incorporating Rapid Diagnostic Tests (RDTs) for Malaria at Peripheral Health Centers in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716599
• Other study ID #: EM-036
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: July 15, 2008
• Start date: January 2008
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUganda: Research Ethics CommitteeMexico: National Council of Science and Technology
• Study type: Interventional

Clinical Trial Summary

Malaria remains one of the most devastating infectious diseases in the world. Despite the potential for serious adverse outcomes with each episode of malaria, most cases in endemic areas are diagnosed on clinical grounds alone. Even the simple technique of light microscopy, the gold standard for malaria diagnosis, is inaccessible to most individuals in resource-poor malarious areas. New diagnostic methods that are practical for limited health-care settings are urgently needed. Immunochromatographic rapid diagnostic tests (RDTs) for malaria are easy to use, require little infrastructure or expertise, show good accuracy, and are increasingly advocated for routine use in malaria-endemic areas. A major challenge now is to implement RDTs effectively in typical African clinical settings. We plan to evaluate the clinical effectiveness and safety of a training curriculum incorporating RDT use in peripheral government health centers in Uganda. Results from this study will provide evidence for scale-up of RDT implementation in Uganda, as planned by the Uganda Ministry of Health from mid-2008, as well as in other sub-Saharan African countries.

The aim of this study is to evaluate the clinical effectiveness and safety of a basic training program incorporating RDTs, as compared with standard-of-care presumptive treatment, for the management of patients who present with suspected malaria at peripheral health centers in Uganda. Our hypothesis is that training in fever case management and RDT use will allow health center staff to reduce unnecessary antimalarial prescriptions without compromising patient outcomes, compared with the current practice of presumptive antimalarial therapy for all febrile patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14000
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all outpatients at participating health centers

Exclusion Criteria:

• patient refusal

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fever
• Malaria

Intervention

Device:
• training in use of rapid diagnostic tests (RDTs) for malaria
training program and introduction of RDTs for use in case management of patients presenting for routine care at government health centers

Locations

Country	Name	City	State
Uganda	Uganda Malaria Surveillance Project	Kampala

Sponsors (6)

Lead Sponsor	Collaborator
University of California, San Francisco	Doris Duke Charitable Foundation, Exxon Mobil, Makerere University, National Institutes of Health (NIH), Uganda Malaria Surveillance Project

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare changes in the proportion of patients prescribed any antimalarial therapy between health centers with and without an RDT training intervention.		point of care	No
Secondary	To compare changes in the proportion of patients with an inadequate response to initial therapy between health centers with and without an RDT training intervention.		5 days after initial clinic visit	Yes

External Links

•   research collaboration website