Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria

Not Applicable

Completed

• Conditions: Fever; Malaria
• Interventions: Device: Rapid diagnostic test; Other: presumptive malaria treatment

• Registration Number: NCT01048801
• 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, 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 community-based drug distributors.The accuracy of RDTs, and the acceptability of this approach, will be evaluated in both low and high transmission areas.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Study Start: 2010-03
• 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: 2000

Inclusion Criteria

• Children aged between 6 months and 5 years (< 5 years)reported with fever by the mother/ caretaker of the child
• Children with uncomplicated malaria/ fever episodes
• Children whose mothers consent to participate

Exclusion Criteria

• Children aged less 6 months or greater than 4 years (≥ 5 years)
• Children requiring referral to a health facility (severe malaria, complicated fever episode, convulsions/fits, loss of consciousness, and other danger signs)
• Children whose mothers refuse to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid diagnostic test and treatment	Rapid diagnostic test	-
Treatment without rapid daignostic test	presumptive malaria treatment	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients given prompt effective treatment by CDDs: % of <5-year-old children diagnosed with malaria who receive appropriate ACT treatment within 24 hours of onset of malaria.	36 months

Secondary Outcome Measures

Name	Time	Method
Coverage of prompt effective treatment: % of <5-year-old children with fever who received ACT treatment within 24 hours of onset of malaria, measured through household surveys.	36 months

Trial Locations

Locations (1)

Rukungiri District; 🇺🇬 Rukungiri, Uganda