Examination of ACT Implementation in a Vivax / Falciparum Co-endemic Area

Phase 4

Completed

• Conditions: Fever; Malaria
• Interventions: Other: Rapid diagnostic test

• Registration Number: NCT00935688
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

In areas of which are co-endemic for vivax and falciparum malaria, treatments for the two diseases often differ and this may lead to mistreatment. This places an emphasis on diagnosis at the health service provision level. Diagnosis is also important when malaris endemicity is low - most fevers are not caused by disease. These two issues mean that most malaria and fevers are not adequately treated, even though the drugs may be effective; many patients who do not have malaria are treated for the disease, and patients with malaria may get the wrong treatment for their species. The study aims to test the effectiveness of employing rapid diagnostic tests and will study the effect on correct treatment.

Detailed Description

The study will randomly assign diagnostic methods, either with clinical diagnosis, field microscopy or rapid diagnostic tests. The study will take place in 22 clinics in Eastern and Northern Afghanistan, both areas with low transmission of predominantly vivax malaria. They differ in their locations and their current standard diagnostic methods.

The study will examine the result of the diagnostic test in the clinic against the result of reference slides and PCR to estimate the number of cases correctly treated in each arm. This will be a measure of the effectiveness of diagnosis (and the physicians response to the diagnosis) and be influential in considering modalities for diagnostic delivery

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4200

Inclusion Criteria

• Any patient where the clinician* considers malaria in the diagnosis - either prescribing an antimalarial or would request a malaria test if available or referring for diagnosis of malaria elsewhere.
• Patient, or parent/guardian, gives informed consent to the study.

Exclusion Criteria

• Patients with a result from another facility
• Patients referred on for diagnosis in the private sector
• Patients the clinician decides to treat presumptively without requesting a test (defined as treating prior to randomisation)
• Where the clinician requests microscopy specifically due to clinical need prior to randomisation will not be randomised in the trial, but will be noted as part of the study and a reference slide and clinical information will be taken following consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid diagnostic tests	Rapid diagnostic test	malaria diagnosis by rapid diagnostic test

Primary Outcome Measures

Name	Time	Method
Proportion of patients correctly treated	2009-2010	Composite measure defined as patients with Pf malaria receiving ACT Drugs; Pv malaria receiving CQ; patients with no malaria receiving no antimalarial drugs.; NOTE: Previously reported here as "Proportion of patients incorrectly treated" being 1 minus the Proportion correctly treated. No change in how the outcome was measured.

Secondary Outcome Measures

Name	Time	Method
% of PV patients not receiving CQ % of PF patients not receiving SP/AS	2009-2010
Diagnostic Accuracy of the different malaria tests	2009-2010	Sensitivity and specificity of mRDTs, Microscopy and clinical diagnosis.

Trial Locations

Locations (2)

HealthNet TPO; 🇦🇫 Jalalabad, Nangahar, Afghanistan

Merlin; 🇦🇫 Kunduz, Afghanistan