Clinical Trials Directory

Trials / Completed

CompletedNCT01967472

Adherence to Antimalarial Drugs in Sierra Leone

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,145 (actual)
Sponsor
London School of Hygiene and Tropical Medicine · Academic / Other
Sex
All
Age
6 Months – 59 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGamodiaquine-artesunate (AQAS) fixed-dose
DRUGArtemether-lumefantrine combination (AL) dispersable

Timeline

Start date
2013-09-16
Primary completion
2013-12-01
Completion
2014-01-01
First posted
2013-10-23
Last updated
2018-01-11

Locations

2 sites across 1 country: Sierra Leone

Source: ClinicalTrials.gov record NCT01967472. Inclusion in this directory is not an endorsement.