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

An Examination of ACT Strategy in South-central Asia on Falciparum Malaria in a Context Where Vivax is the Major Species

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.

Study Overview

• Status: Completed
• Conditions: Fever; Malaria
• Intervention / Treatment: Other: Rapid diagnostic test

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 Type: Interventional
• Enrollment (Actual): 4200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Afghanistan
  • Kunduz, Afghanistan
    • Merlin
  • Nangahar
    • Jalalabad, Nangahar, Afghanistan
      • HealthNet TPO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapid diagnostic tests; malaria diagnosis by rapid diagnostic test	Other: Rapid diagnostic test; Dual species test for P. vivax and P. falciparum malaria
No Intervention: Clinic Microscopy; malaria diagnosed with field light-microscopy
No Intervention: Clinical Diagnosis; Malaria diagnosed on the basis of clinical symptoms alone (i.e. not laboratory diagnosis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients correctly treated	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.	2009-2010

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: HealthNet TPO; Health Protection and Research Organisation; Medical Emergency Relief International (Merlin)

Publications and helpful links

General Publications

• Hansen KS, Grieve E, Mikhail A, Mayan I, Mohammed N, Anwar M, Baktash SH, Drake TL, Whitty CJ, Rowland MW, Leslie TJ. Cost-effectiveness of malaria diagnosis using rapid diagnostic tests compared to microscopy or clinical symptoms alone in Afghanistan. Malar J. 2015 May 28;14:217. doi: 10.1186/s12936-015-0696-1.
• Leslie T, Mikhail A, Mayan I, Cundill B, Anwar M, Bakhtash SH, Mohammed N, Rahman H, Zekria R, Whitty CJ, Rowland M. Rapid diagnostic tests to improve treatment of malaria and other febrile illnesses: patient randomised effectiveness trial in primary care clinics in Afghanistan. BMJ. 2014 Jun 19;348:g3730. doi: 10.1136/bmj.g3730.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (Estimate): July 9, 2009

Study Record Updates

• Last Update Posted (Estimate): February 7, 2014
• Last Update Submitted That Met QC Criteria: February 6, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: malaria; rapid diagnostic tests; afghanistan; Non-specific fever
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: ACT Consortium