Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs

Summary

This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The primary activity of the study wil be a two armed cluster randomised trial in two study sites in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic and the other meso-endemic for malaria. In one arm the children will be treated presumptively for malaria with ACT (control arm) and the other arm the children will receive ACT only when they have a positive RDT result (implementation arm). The children in the implementation arm will also receive antibiotics if they have a raised respiratory rate. The primary outcome will be the recovery rate in the intervention arm compared to that of the control arm on Day 3. In addition, an acceptability assessment of RDTs in the community will be undertaken both before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to demonstrate comparable levels of endemicity in control and intervention groups. These activities will be carried out over a two year period.

Conditions

• Malaria
• Pneumonia

Interventions

DRUG

Artemether-lumefantrine combination

20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days

DRUG

amoxycillin

amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2

DRUG

paracetamol

paracetamol 500mg tablet \<36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days

DEVICE

malaria rapid diagnostic test, respiratory rate timer

malaria dipstick, and breath timer

DRUG

Artemether-lumefantrine combination

20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2

Sponsors & Collaborators

• Makerere University

  collaborator OTHER

• Ministry of Health, Uganda

  collaborator OTHER_GOV

• Navrongo Health Research Centre, Ghana

  collaborator OTHER

• National Malaria Research and Training Centre, Burkina Faso

  collaborator UNKNOWN

• Mbarara University of Science and Technology

  lead OTHER

Principal Investigators

• Francis Bajunirwe, MBChB PhD · Mbarara University of Science and Technology

• George Pariyo, MB ChB, PhD · Makerere University

• James Tibenderana, MB ChB, PhD · Malaria Consortium

• Alfred Tiono, PhD · National Malaria Research and Training Center, Burkina Faso

• Thomas Anyorigiya, MSc · Navrongo Health Research Centre, Ghana

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2012-01-31

Completion

2012-01-31

Countries

• Burkina Faso
• Ghana
• Uganda

Study Locations