Adherence to Antimalarial Drugs in Sierra Leone

Study Overview
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Brief Summary
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The aim of this study is to address this gap in knowledge by measuring the level of patient adherence to co-formulated amodiaquine and artesunate (AQ-AS) compared to artemether-lumefantrine (AL) under routine conditions in Sierra Leone and explore the key factors that influence adherence. This will be addressed through a mixed methods study that will provide not only a measurement of adherence ACTs and malaria test results, but will also provide contextual information in order to better understand factors that affect adherence. Data will be collected through a series of interviews with health workers and parents/caregivers and through observations of patient-provider consultations. The first stage of the study begins with semi-structured interviews and observations of patients/caretakers' consultations with health workers and will look at how health workers diagnose and treat malaria. This will be followed by short exit interviews at the health facility with caregivers to assess patient satisfaction with services, as well as to test the consistency between the data obtained through structured observations and the exit interviews. Follow-up surveys at the homes of patients will be used to measure and compare the adherence of participants to two different ACTs (AQAS and AL) formulations and potential factors that affect adherence. Additionally, data will be collected using in-depth interviews to collect supplementary information in order to discover, in more detail, factors that may affect behavioral choices and/or attitudes with regard to adherence.

Official Title
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Adherence to Artemisinin-Based Combination Therapy (ACT) for the Treatment of Malaria in Sierra Leone

Conditions
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Malaria

Intervention / Treatment
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* Drug: amodiaquine-artesunate (AQAS) fixed-dose
* Drug: Artemether-lumefantrine combination (AL) dispersable


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is a child between 6 to 59 months Visiting health facility for treatment of fever Do not have signs of severe disease Are not being referred to another health facility Living within a defined distance from the health facility (<8 km/ 5 miles) Have not taken part in the study already or are not part of a household that has already taken part in the study Responsible caretakers/parents provide additional informed consent Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: co-formulated Amodiaquine-Artesunate<br>Sanofi Coarsucam Infant dose (2-12 months/4.5-8kg), amodiaquine:67.5mg/artesunate 25mg; 1 tablet once a day for 3 days. Sanofi Coarsucam Young Child (13-59 months/9-17kg), amodiaquine: 136mg/artesunate 50mg; 1 tablet once a day for 3 days. | Drug: amodiaquine-artesunate (AQAS) fixed-dose<br> <br> * Other names: coarsucam, winthrop, co-formulated;|
| Active Comparator: artemether-lumefantrine<br>Novartis coartem infant dose (2-11 months/5-14kg), artemether 20mg/lumefantrine 120mg; 1 tablet twice a day for 3 days. Novartis coartem child dose (12-59 months/15-24kg), artemether 20mg/lumefantrine 120mg; 2 tablets twice a day for 3 days | Drug: Artemether-lumefantrine combination (AL) dispersable<br> <br> * Other names: coartem, AL, locally all Artemether-lumefantrine called 'lokmal';|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Adherence is measured on the day following the last day of treatment. Adherence is defined as taking all of the prescribed dose at the correct time. | Day 4 |