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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This is an open, cluster randomised multicentre two arm trial in the three countries of Burkina Faso, Ghana and Uganda. Clusters are villages (catchment populations) of individual community health workers (CHWs). Within the study areas, clusters that are more than 5 km from a designate health facility where CHWs referred cases for special care will be excluded. A cluster randomized design was chosen over an individually randomized design to reduce contamination, facilitate supervision, reduce costs, and to ensure that the CHWs maintained the correct treatments based on the tests in the Intervention arm and the presumptive treatment in the Control arm.

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

Conditions
-----------------
Malaria, Pneumonia

Intervention / Treatment
-----------------
* Drug: Artemether-lumefantrine combination
* Drug: amoxycillin
* Drug: paracetamol
* Device: malaria rapid diagnostic test, respiratory rate timer
* Drug: Artemether-lumefantrine combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between 4-59 months of age with a history of fever in the last 24 hours presenting to the community medicine distributor Exclusion Criteria: Children classified as having severe illness according to IMCI guidelines. Children suffering from Chronic disease(s), those with reported anti malarial or antibiotic treatment (intervention) arm in previous two weeks and those whose caregivers refuse to consent to participate

Ages Eligible for Study
-----------------
Minimum Age: 4 Months
Maximum Age: 59 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT, antibiotic, paracetamol<br>CHWs will test children with acute febrile illness for malaria using RDTs, and for pneumonia by counting their respiratory rate with RRTs. Treatment will then be provided on the basis of the test results, in line with national guidelines. Children with a positive RDT will receive artemether-lumefantrine in Burkina Faso and Uganda, and artesunate-amodiaquine in Ghana. Children with a cough and a high respiratory rate will receive amoxicillin in Ghana and Uganda, and cotrimoxazole in Burkina Faso. Additionally, paracetamol (PCT) will be provided to all children with an axillary temperature > 38.5°C. | Drug: Artemether-lumefantrine combination<br>* 20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days<br>* Other names: Coartem;Drug: amoxycillin<br>* amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2<br>Drug: paracetamol<br>* paracetamol 500mg tablet <36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days<br>Device: malaria rapid diagnostic test, respiratory rate timer<br>* malaria dipstick, and breath timer<br>|
| No Intervention: Presumptive fever management<br>Presumptive treatment of malaria with ACTs. No antibiotic treatment available | Drug: Artemether-lumefantrine combination<br>* 20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate from fever at Day 3 |  | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of antimalarial and antibiotic drugs by community health workers |  | After patient enrollment | 
| Recovery rate from fever at Day 7 |  | Day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malaria ACT, Rapid, Diagnosis, Community, health, worker, Artemesinin, based, Combination, Therapy, Anti Malarial, Treatment, antibiotics