Introducing Rapid Diagnostic Tests Into the Private Health Sector

Not Applicable

Completed

• Conditions: Fever; Malaria; Diagnosis; Referral
• Interventions: Device: Rapid diagnostic test; Drug: Lumartem

• Registration Number: NCT01194557
• Lead Sponsor: DBL -Institute for Health Research and Development

Brief Summary

Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and impact, artemisinin combination therapies (ACTs) should be deployed in HMM programmes, as well as in formal health facilities. Up to 80% of malaria cases are treated outside the formal health sector and shops are frequently visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role of shops in home management and to ensure that drugs sold are appropriate. The current practice of presumptive treatment of any febrile illness as malaria (both at health facilities and in the context of HMM) based solely on clinical symptoms without routine laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT being a more costly regimen, it is important to be more restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in remote locations lacking electricity and qualified health staff.

This study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by ocal drug shops in an area with high malaria transmission.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-11
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2600

Inclusion Criteria

• Patients with fever
• uncomplicted malaria

Exclusion Criteria

• Complicated malaria
• known allergic reactions to Lumartem

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rapid diagnostic test	Rapid diagnostic test	Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests
rapid diagnostic test	Lumartem	Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests

Primary Outcome Measures

Name	Time	Method
Appropriateness of treatment	36 months

Secondary Outcome Measures

Name	Time	Method
Appropriateness of referral of complicated malaria cases	36 months

Trial Locations

Locations (1)

Mukono District; 🇺🇬 Mukono, Uganda