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

NCT01048801 | Completed DMC

• 1 other identifier: ACTUGA2
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients given prompt effective treatment by CDDs: % of <5-year-old children diagnosed with malaria who receive appropriate ACT treatment within 24 hours of onset of malaria.

  36 months

Secondary Outcomes (1)

• Coverage of prompt effective treatment: % of <5-year-old children with fever who received ACT treatment within 24 hours of onset of malaria, measured through household surveys.

  36 months

Study Arms (2)

Rapid diagnostic test and treatment

ACTIVE COMPARATOR

Device: Rapid diagnostic test

Treatment without rapid daignostic test

OTHER

Other: presumptive malaria treatment

Interventions

Rapid diagnostic test DEVICE

Use of rapid daignostic tests for diagnosis of malaria

Rapid diagnostic test and treatment

presumptive malaria treatment OTHER

Treatment of malariabased on clinical diagnosis without use of diagnostic test

Treatment without rapid daignostic test

Eligibility Criteria

• Age: 5 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DBL -Institute for Health Research and Development: lead
• Ministry of Health, Uganda: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• Artemisinin-based Combination Therapy: collaborator

Study Sites (1)

Rukungiri District

Rukungiri, Rukungiri, 0000, Uganda

Location

Related Publications (2)

• 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.

  PMID: 21176131 RESULT

• 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.

  PMID: 29720163 DERIVED

MeSH Terms

Conditions

Fever; Malaria

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• Richard Ndyomugyenyi, MD

  Ministry of Health, Uganda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior researcher

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 14, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 12, 2012

Record last verified: 2012-10

Locations

UG (1)