Introducing Rapid Diagnostic Tests Into the Private Health Sector

Malaria Clinical Trial

Official title: Introducing Rapid Diagnostic Tests Into the Private Health Sector in Uganda: a Randomised Trial Among Registered Drug Shops to Evaluate Impact on Antimalarial Drug Use

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

• Diagnosis
• Fever
• Malaria
• Referral

• NCT number: NCT01194557
• Study type: Interventional
• Source: DBL -Institute for Health Research and Development
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Completion date: July 2012