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NCT Number: NCT01048801

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

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.

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Key information

Age range

5 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rukungiri District

Rukungiri, 0000, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid diagnostic test

Device

Use of rapid daignostic tests for diagnosis of malaria

presumptive malaria treatment

Other

Treatment of malariabased on clinical diagnosis without use of diagnostic test

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.

    Time frame: 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.

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

DBL -Institute for Health Research and Development

Other

Collaborators

  • Artemisinin-based Combination Therapy
  • London School of Hygiene and Tropical Medicine
  • Ministry of Health, Uganda

Registry information

Official study 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

Acronym: ACTUGA2

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 14, 2010
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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