drugset / Trial / NCT01967472

Adherence to Antimalarial Drugs in Sierra Leone

NCT01967472

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-09-16
Primary completion
2013-12
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Artemether Small molecule 20 mg
Comparator Artemether Small molecule 40 mg
Comparator Artesunate Small molecule 25 mg
Comparator Artesunate Small molecule 50 mg
Comparator amodiaquine Other / unclassified 67.5 mg
Comparator amodiaquine Other / unclassified 136 mg
Comparator lumefantrine Small molecule 120 mg
Comparator lumefantrine Small molecule 240 mg

Indications