Cluster Randomized Trial of Rapid Diagnostic Tests for Home Management of Malaria in Children aged 6 to 59 Months in The Gambia

A cluster randomized trial in children aged 6 to 59 months comparing the effect of the diagnosis of malaria by village health workers using Rapid Diagnostic Tests (RDT) with the diagnosis of malaria by village health workers using clinical guidelines on the rational treatment of malaria using Artemisinin Combination Therapy (ACT)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609001057279

Enrollment

1200

Registered

2009-12-10

Start date

2010-01-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project has been designed to assess the effectiveness of rapid diagnostic tests (RDT) used by village health workers in improving appropriate diagnosis and rational treatment of malaria under routine conditions of disease control. A cluster randomized trial with two arms has been proposed. In both the intervention and control arms of the study, village health workers manage febrile children according to nationally adapted IMCI guidelines. However, in the intervention arm, they will be trained to use RDTs to confirm the diagnosis of malaria before providing treatment. Eight villages (480 children) will be included in each arm of the trial to enable detection of a 25% difference in the proportion of cases of febrile children given ACT in the intervention villages (RDT) compared to the control villages (no RDT) during either the malarial or non-malarial seasons at the 5% significance level with 90% power.

Interventions

The Village health worker will obtain blood from a child with fever via a finger prick test. The blood specimen collected from the child is applied to a dipstick containing nitrocellulose. After 15 minutes, the presence of specific bands in the test card window indicate whether the patient is infected with Plasmodium falciparum . The intervention program will last for the duration of the trial, that is 16 months, whenever a child presents with fever and is suspected of having malaria.

Study design

Allocation

Randomised controlled trial

Primary purpose

Diagnosis

Eligibility

Sex/Gender

All

Age

6 Months to 59 Months

Healthy volunteers

Inclusion criteria

Fever or history of fever Age 6-59 months Weight greater than 5 kg Written informed consent from parent/guardian

Exclusion criteria

History of adverse reaction to any of the study medications. Presence of any Integrated Management of Childhood Illnesses (IMCI) danger sign Any child known to be Human Immunodeficiency Virus (HIV) positive will not be enrolled. Any the other findings which in the opinion of the investigators will result in an adverse outcome due to participation in the trial.

Outcome results