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Introducing Rapid Diagnostic Tests Into the Private Health Sector

NCT01194557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2600

Last updated 2012-10-12

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Rapid diagnostic test

Diagnosis of malaria using rapid diagnostic test

DRUG

Lumartem

Presumptive treatment of malaria/fever

Sponsors & Collaborators

  • Ministry of Health, Uganda

    collaborator OTHER_GOV

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Artemisinin-based Combination Therapy

    collaborator OTHER

  • DBL -Institute for Health Research and Development

    lead OTHER

Principal Investigators

  • Anthony K Mbonye, PhD · Ministry of Health, Uganda

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01194557 on ClinicalTrials.gov