Cluster Randomised Trial of Malaria RDTs Used by CHWs in Afghanistan

NCT01403350 | Completed Phase 4 DMC

• 1 other identifier: 5911
• Study Type: interventional
• Target: 2,421
• Locations: 1 country
• Sites: 3

Brief Summary

Malaria is a common, but decreasing, cause of fever in endemic areas. The use of rapid diagnostic tests could improve treatment of malaria at the local community level. Deployment of these tests is, however, a considerable cost. The aim of the study is to evaluate their effect on improving treatment of fever when used by Community Health Workers in Afghanistan. In phase I of the study, the hypothesis is that an RDT diagnosis deployed with standard training and support will improve the accuracy of treatment applied to fever by community health workers when compared to a diagnosis that is based on symptoms alone. In Phase II of the study, the hypothesis is that the accuracy of treatment can be improved by additional training and supportive interventions given to community health workers compared to those who have only had standard training.

Conditions

Malaria; Fever; Acute Febrile Illness; Pneumonia

Keywords

Malaria; Fever; Acute febrile illness; Pneumonia; Community health worker; Rapid diagnostic test

Outcome Measures

Primary Outcomes (1)

• Proportion of cases correctly treated

  Correctly treated defined as: Those with PCR positive blood sample given an appropriate antimalarial; Those with PCR negative blood sample not given any antimalarial

  Outcomes measured during consultation - approximately 30-40 minutes

Secondary Outcomes (4)

• Proportion of falciparum patients treated with artesunate combination therapy

  Outcomes measured during consultation - approximately 30-40 minutes

• Accuracy of the RDT

  Outcomes measured during consultation - approximately 30-40 minutes

• Accuracy of treatment given by the CHW in response to the RDT result

  Outcomes measured during consultation - approximately 30-40 minutes

• Cost effectiveness of the intervention(s)

  Outcomes measured during consultation - approximately 30-40 minutes

Study Arms (2)

Current Practice

NO INTERVENTION

Study Phase I: No RDT or other parasite based diagnosis; Study Phase II: RDT used under the standard programme of training and support

Intervention Arm

ACTIVE COMPARATOR

Study Phase I: RDT used under the standard programme of training and support; Study Phase II: RDTs deployed with additional programme components including improved training and supportive interventions

Device: Malaria Rapid Diagnostic test

Interventions

Malaria Rapid Diagnostic test DEVICE

Study Phase I: RDT used under the standard programme of training and support; Study Phase II: RDTs deployed with additional programme components including improved training and supportive interventions

Also known as: RDT: CareStart Pf/Pan Rapid Diagnostic Test (national standard RDT)

Intervention Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient where the CHW\* or 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.
• \* \*any community health worker who consults with patients and prescribes treatment, and is administratively attached to one of the study clinics.
• Patient, or parent/guardian, gives informed consent to the study.

You may not qualify if:

• Patients with a diagnostic result from another facility.
• Patients referred on for diagnosis in the private sector.
• Patients who have signs of severe or complicated disease and are referred prior to giving any diagnosis using the interventions.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Health Protection and Research Organisation: collaborator
• HealthNet TPO: collaborator
• Medical Emergency Relief International: collaborator

Study Sites (3)

HealthNet TPO

Jalalabad, Nangarhar, Afghanistan

Location

Health Protection and Research Organisation

Kabul, 0000, Afghanistan

Location

Merlin

Kunduz, Afghanistan

Location

Related Publications (1)

• Leslie T, Rowland M, Mikhail A, Cundill B, Willey B, Alokozai A, Mayan I, Hasanzai A, Baktash SH, Mohammed N, Wood M, Rahimi HU, Laurent B, Buhler C, Whitty CJM. Use of malaria rapid diagnostic tests by community health workers in Afghanistan: cluster randomised trial. BMC Med. 2017 Jul 7;15(1):124. doi: 10.1186/s12916-017-0891-8.

  PMID: 28683750 DERIVED

MeSH Terms

Conditions

Malaria; Fever; Pneumonia

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Toby Leslie, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 15, 2022

Record last verified: 2014-02

Locations

AF (3)