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

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 4

Conditions: Fever; Malaria

Treatments: Other: Rapid diagnostic test

Study type: Interventional

Funder types: Other

Identifiers

NCT00935688

ACT Consortium

Details and patient eligibility

About

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.

Full 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

Enrollment: 4,200 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,200 participants in 3 patient groups

Rapid diagnostic tests

Experimental group

Description:

malaria diagnosis by rapid diagnostic test

Treatment:

Other: Rapid diagnostic test

Clinic Microscopy

No Intervention group

Description:

malaria diagnosed with field light-microscopy

Clinical Diagnosis

No Intervention group

Description:

Malaria diagnosed on the basis of clinical symptoms alone (i.e. not laboratory diagnosis)