Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria (ACTUGA2)
Primary Purpose
Fever, Malaria
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Rapid diagnostic test
presumptive malaria treatment
Sponsored by
About this trial
This is an interventional treatment trial for Fever focused on measuring History of fever, measured fever
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
Sites / Locations
- Rukungiri District
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Rapid diagnostic test and treatment
Treatment without rapid daignostic test
Arm Description
Outcomes
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.
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.
Full Information
NCT ID
NCT01048801
First Posted
January 13, 2010
Last Updated
October 11, 2012
Sponsor
DBL -Institute for Health Research and Development
Collaborators
Ministry of Health, Uganda, London School of Hygiene and Tropical Medicine, Artemisinin-based Combination Therapy
1. Study Identification
Unique Protocol Identification Number
NCT01048801
Brief Title
Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria
Acronym
ACTUGA2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DBL -Institute for Health Research and Development
Collaborators
Ministry of Health, Uganda, London School of Hygiene and Tropical Medicine, Artemisinin-based Combination Therapy
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Malaria
Keywords
History of fever, measured fever
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid diagnostic test and treatment
Arm Type
Active Comparator
Arm Title
Treatment without rapid daignostic test
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Rapid diagnostic test
Intervention Description
Use of rapid daignostic tests for diagnosis of malaria
Intervention Type
Other
Intervention Name(s)
presumptive malaria treatment
Intervention Description
Treatment of malariabased on clinical diagnosis without use of diagnostic test
Primary Outcome Measure Information:
Title
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.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Ndyomugyenyi, MD
Organizational Affiliation
Ministry of Health, Uganda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rukungiri District
City
Rukungiri
ZIP/Postal Code
0000
Country
Uganda
12. IPD Sharing Statement
Citations:
PubMed Identifier
21176131
Citation
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.
Results Reference
result
PubMed Identifier
29720163
Citation
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.
Results Reference
derived
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Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria
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