Adherence to Antimalarial Drugs in Sierra Leone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-16

Study Completion Date

2014-01-31

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.

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Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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co-formulated Amodiaquine-Artesunate

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.

Group Type ACTIVE_COMPARATOR

amodiaquine-artesunate (AQAS) fixed-dose

Intervention Type DRUG

artemether-lumefantrine

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

Group Type ACTIVE_COMPARATOR

Artemether-lumefantrine combination (AL) dispersable

Intervention Type DRUG

Interventions

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amodiaquine-artesunate (AQAS) fixed-dose

Intervention Type DRUG

Artemether-lumefantrine combination (AL) dispersable

Intervention Type DRUG

Other Intervention Names

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coarsucam, winthrop, co-formulated coartem, AL, locally all Artemether-lumefantrine called 'lokmal'

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