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

Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria: Comparative Trials in Two Areas of High and Low Transmission in Uganda

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01048801
Acronym
ACTUGA2
Enrollment
2000
Registered
2010-01-14
Start date
2010-03-31
Completion date
2012-07-31
Last updated
2012-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Malaria

Keywords

History of fever, measured fever

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.

Interventions

Use of rapid daignostic tests for diagnosis of malaria

OTHERpresumptive malaria treatment

Treatment of malariabased on clinical diagnosis without use of diagnostic test

Sponsors

Ministry of Health, Uganda
CollaboratorOTHER_GOV
London School of Hygiene and Tropical Medicine
CollaboratorOTHER
Artemisinin-based Combination Therapy
CollaboratorOTHER
DBL -Institute for Health Research and Development
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Months to 59 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026