ACTUGA2: Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria
Study Details
Study Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Rapid diagnostic test and treatment
|
Device: Rapid diagnostic test
Use of rapid daignostic tests for diagnosis of malaria
|
| Other: Treatment without rapid daignostic test
|
Other: presumptive malaria treatment
Treatment of malariabased on clinical diagnosis without use of diagnostic test
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rukungiri District | Rukungiri | Uganda | 0000 |
Sponsors and Collaborators
- DBL -Institute for Health Research and Development
- Ministry of Health, Uganda
- London School of Hygiene and Tropical Medicine
- Artemisinin-based Combination Therapy
Investigators
- Principal Investigator: Richard Ndyomugyenyi, MD, Ministry of Health, Uganda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACTUGA2