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Adherence to Antimalarial Drugs in Sierra Leone

NCT01967472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1145

Last updated 2018-01-11

No results posted yet for this study

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

DRUG

amodiaquine-artesunate (AQAS) fixed-dose

DRUG

Artemether-lumefantrine combination (AL) dispersable

Sponsors & Collaborators

  • National Malaria Control Program, Ministry of Health and Sanitation

    collaborator UNKNOWN

  • Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation

    collaborator UNKNOWN

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Kristin Banek · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-16
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • Sierra Leone

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01967472 on ClinicalTrials.gov