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

DBL -Institute for Health Research and Development

Status

Completed

Conditions

Fever

Malaria

Treatments

Other: presumptive malaria treatment

Device: Rapid diagnostic test

Study type

Interventional

Funder types

Other

Identifiers

NCT01048801

ACTUGA2

Details and patient eligibility

About

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.

Enrollment

2,000 patients

Sex

All

Ages

5 to 59 months old

Volunteers

No Healthy Volunteers

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