Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria

NCT ID: NCT01048801

Last Updated: 2012-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-07-31

Brief 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, 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 community-based drug distributors.The accuracy of RDTs, and the acceptability of this approach, will be evaluated in both low and high transmission areas.

Conditions

Fever; Malaria

Keywords

History of fever; measured fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rapid diagnostic test and treatment

Group Type: ACTIVE_COMPARATOR

Rapid diagnostic test

Intervention Type: DEVICE

Use of rapid daignostic tests for diagnosis of malaria

Treatment without rapid daignostic test

Group Type: OTHER

presumptive malaria treatment

Intervention Type: OTHER

Treatment of malariabased on clinical diagnosis without use of diagnostic test

Interventions

Rapid diagnostic test

Use of rapid daignostic tests for diagnosis of malaria

Intervention Type: DEVICE

presumptive malaria treatment

Treatment of malariabased on clinical diagnosis without use of diagnostic test

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children aged between 6 months and 5 years (< 5 years)reported with fever by the mother/ caretaker of the child
• Children with uncomplicated malaria/ fever episodes
• Children whose mothers consent to participate

Exclusion Criteria

• Children aged less 6 months or greater than 4 years (≥ 5 years)
• Children requiring referral to a health facility (severe malaria, complicated fever episode, convulsions/fits, loss of consciousness, and other danger signs)
• Children whose mothers refuse to consent

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Uganda

OTHER_GOV

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

Artemisinin-based Combination Therapy

OTHER

Sponsor Role: collaborator

DBL -Institute for Health Research and Development

OTHER

Sponsor Role: lead

Responsible Party

Pascal Magnussen

senior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Ndyomugyenyi, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Uganda

Locations

Rukungiri District

Rukungiri, Rukungiri, Uganda

Countries

Uganda

References

Mbonye AK, Ndyomugyenyi R, Turinde A, Magnussen P, Clarke S, Chandler C. The feasibility of introducing rapid diagnostic tests for malaria in drug shops in Uganda. Malar J. 2010 Dec 21;9:367. doi: 10.1186/1475-2875-9-367.

Reference Type: RESULT

PMID: 21176131 (View on PubMed)

Lal S, Ndyomugenyi R, Paintain L, Alexander ND, Hansen KS, Magnussen P, Chandramohan D, Clarke SE. Caregivers' compliance with referral advice: evidence from two studies introducing mRDTs into community case management of malaria in Uganda. BMC Health Serv Res. 2018 May 2;18(1):317. doi: 10.1186/s12913-018-3124-8.

Reference Type: DERIVED

PMID: 29720163 (View on PubMed)

Other Identifiers

ACTUGA2

Identifier Type: -

Identifier Source: org_study_id