Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria (ACTUGA2)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Uganda
London School of Hygiene and Tropical Medicine
Artemisinin based combination Therapies Consortium
Information provided by (Responsible Party):
Pascal Magnussen, DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier:
NCT01048801
First received: January 13, 2010
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Fever
Malaria
Device: Rapid diagnostic test
Other: presumptive malaria treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by DBL -Institute for Health Research and Development:

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. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 2000
Study Start Date: March 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rapid diagnostic test and treatment Device: Rapid diagnostic test
Use of rapid daignostic tests for diagnosis of malaria
Treatment without rapid daignostic test Other: presumptive malaria treatment
Treatment of malariabased on clinical diagnosis without use of diagnostic test

  Eligibility

Ages Eligible for Study:   5 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048801

Locations
Uganda
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 Therapies Consortium
Investigators
Principal Investigator: Richard Ndyomugyenyi, MD Ministry of Health, Uganda
  More Information

Publications:
Responsible Party: Pascal Magnussen, senior researcher, DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier: NCT01048801     History of Changes
Other Study ID Numbers: ACTUGA2
Study First Received: January 13, 2010
Last Updated: October 11, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by DBL -Institute for Health Research and Development:
History of fever
measured fever

Additional relevant MeSH terms:
Fever
Malaria
Body Temperature Changes
Signs and Symptoms
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 28, 2014