Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001057279
Ethics application status
Approved
Date submitted
8/12/2009
Date registered
10/12/2009
Date last updated
10/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Cluster Randomized Trial of Rapid Diagnostic Tests for Home Management of Malaria in Children aged 6 to 59 Months in The Gambia
Scientific title
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)
Secondary ID [1] 1184 0
Nil
Universal Trial Number (UTN)
U1111-1112-7894
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malaria 252357 0
Condition category
Condition code
Infection 256546 256546 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 255665 0
Diagnosis / Prognosis
Comparator / control treatment
The Village Health workers will use guidelines developed for the Integrated Management of Childhood Illness to manage a child with fever. In the guidelines, a child with fever and no other clinical symptoms or signs is treated presumptively for malaria. The presumptive treatment of malaria using the guidelines will last for the duration of the trial, that is 16 months, whenever a child with fever presents to village health workers who diagnosis malaria clinically. The unit of randomisation is a village. Villages will be randomised so that all children in trial villages will be diagnosed using RDT or clinical guidelines. Treatment with Artemisinin Combination Therapy is part of the study. A child diagnosed with malaria will be treated with Arthemeter/lumefantrine (Coartem) oral tablets. Coartemether is a 1:6 fixed-combination drug consisting of two components with tablets containing artemether (20 mg) and lumefantrine (120 mg). Treatment will last for 3 days and the dosage for artemether/lumefantrine is as follows:
6 months – 35 months (day 1: 1 tablet twice a day; day 2: 1 tablet twice a day and day 3: 1 tablet twice a day)
3-5 years (day 1: 2 tablets twice a day; day 2: 2 tablets twice a day and day 3: 2 tablets twice a day)
Control group
Active

Outcomes
Primary outcome [1] 253426 0
Proportion of febrile children with no malaria parasites on expert microscopy that receive ACT
Timepoint [1] 253426 0
At end of malaria season:July to November
At end of non malaria season: December to June
Secondary outcome [1] 262544 0
Proportion of fevers due to malaria on a year round basis at community level. This outcome will be assessed by expert microscopy of blood samples
Timepoint [1] 262544 0
At end of malaria season:July to November
At end of non malaria season: December to June
Secondary outcome [2] 262545 0
Proportion of RDT negative children hospitalized for malaria (based on expert microscopy)
Timepoint [2] 262545 0
At end of malaria season:July to November
At end of non malaria season: December to June
Secondary outcome [3] 262546 0
Proportion of villagers and village health workers expressing satisfaction with RDT. This will be assessed using interviews
Timepoint [3] 262546 0
End of trial- 16 months
Secondary outcome [4] 262547 0
Cost effectiveness of treatment of Rapid Diagnostic Test confirmed malaria in a setting where malaria is seasonal and declining. This will be done using Cost Effectiveness Analysis
Timepoint [4] 262547 0
End of trial- at 16 months
Secondary outcome [5] 262548 0
Effectiveness of RDTs kept under field conditions by non-skilled medical workers. The effectiveness of RDTs stored by village health workers will be assessed by randomly selecting RDT kits in their possession at regular intervals and using it to test a reference blood sample
Timepoint [5] 262548 0
Periodic- every 6 months

Eligibility
Key inclusion criteria
Fever or history of fever
Age 6-59 months
Weight greater than 5 kg
Written informed consent from parent/guardian
Minimum age
6 Months
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment outside Australia
Country [1] 2358 0
Gambia
State/province [1] 2358 0

Funding & Sponsors
Funding source category [1] 256143 0
Other
Name [1] 256143 0
United Nations Children's Fund (UNICEF) / United Nations Development Programme (UNDP) / World Bank / World Health Organisation (WHO) Special Programme for Research and Training in Tropical Diseases (TDR)
Country [1] 256143 0
Switzerland
Primary sponsor type
Other
Name
CIAM-Public Health Research & Development Centre
Address
Plot 17, Kanifing Institutional Layout
PO Box 2723
Serrekunda
Country
Gambia
Secondary sponsor category [1] 251486 0
None
Name [1] 251486 0
Address [1] 251486 0
Country [1] 251486 0
Other collaborator category [1] 990 0
Other
Name [1] 990 0
Medical Research Council Laboratories, The Gambia
Address [1] 990 0
Atlantic Boulevard
Fajara
P.O.Box 273
Banjul
Country [1] 990 0
Gambia
Other collaborator category [2] 995 0
Individual
Name [2] 995 0
Stephen Obaro
Address [2] 995 0
Department of Pediatrics and Human Development, Michigan State University,
East Lansing MI
Country [2] 995 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258237 0
Gambia Government/Medical Research Council (MRC) Laboratories Joint Ethics Committee
Ethics committee address [1] 258237 0
c/o MRC
Fajara
PO Box 273
Banjul
Ethics committee country [1] 258237 0
Gambia
Date submitted for ethics approval [1] 258237 0
Approval date [1] 258237 0
25/09/2009
Ethics approval number [1] 258237 0
Ethics committee name [2] 258238 0
Research Ethics Review Committee (WHO ERC)
Ethics committee address [2] 258238 0
WHO
20, Avenue Appia
CH-1211 Geneva 27
Ethics committee country [2] 258238 0
Switzerland
Date submitted for ethics approval [2] 258238 0
Approval date [2] 258238 0
24/11/2009
Ethics approval number [2] 258238 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30595 0
Address 30595 0
Country 30595 0
Phone 30595 0
Fax 30595 0
Email 30595 0
Contact person for public queries
Name 13842 0
Ayo Palmer
Address 13842 0
CIAM-Public Health Research & Development Centre
Plot 17,
Kanifing Institutional Layout
PO Box 2723
Serrekunda
Country 13842 0
Gambia
Phone 13842 0
(220) 4394592
Fax 13842 0
(220) 4394484
Email 13842 0
ayo.palmer@ciam.gm
Contact person for scientific queries
Name 4770 0
Ayo Palmer
Address 4770 0
CIAM-Public Health Research & Development Centre
Plot 17,
Kanifing Institutional Layout
PO Box 2723
Serrekunda
Country 4770 0
Gambia
Phone 4770 0
(220) 4394592
Fax 4770 0
(220) 4394484
Email 4770 0
ayo.palmer@ciam.gm

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Results publications and other study-related documents

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