Adherence to Antimalarial Drugs in Sierra Leone

London School of Hygiene and Tropical Medicine

Status: Completed

Conditions: Malaria

Treatments: Drug: amodiaquine-artesunate (AQAS) fixed-dose; Drug: Artemether-lumefantrine combination (AL) dispersable

Study type: Interventional

Funder types: Other

Identifiers

NCT01967472

SL-ACT-01

Details and patient eligibility

About

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.

Enrollment: 1,145 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,145 participants in 2 patient groups

co-formulated Amodiaquine-Artesunate

Active Comparator group

Description:

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.

Treatment:

Drug: amodiaquine-artesunate (AQAS) fixed-dose

artemether-lumefantrine

Active Comparator group

Description:

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

Treatment:

Drug: Artemether-lumefantrine combination (AL) dispersable