Adherence to Antimalarial Drugs in Sierra Leone

Not Applicable

Completed

• Conditions: Malaria
• Interventions: Drug: amodiaquine-artesunate (AQAS) fixed-dose; Drug: Artemether-lumefantrine combination (AL) dispersable

• Registration Number: NCT01967472
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-16
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-23
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
co-formulated Amodiaquine-Artesunate	amodiaquine-artesunate (AQAS) fixed-dose	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.
artemether-lumefantrine	Artemether-lumefantrine combination (AL) dispersable	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

Primary Outcome Measures

Name	Time	Method
Adherence	Day 4	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.

Trial Locations

Locations (2)

Ross Road Health Facility; 🇸🇱 Freetown, Sierra Leone

George Brook Health Center; 🇸🇱 Freetown, Sierra Leone