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Clinical Trials/NCT01967472
NCT01967472
Completed
Not Applicable

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

London School of Hygiene and Tropical Medicine2 sites in 1 country1,145 target enrollmentSeptember 16, 2013

Overview

Phase
Not Applicable
Intervention
amodiaquine-artesunate (AQAS) fixed-dose
Conditions
Malaria
Sponsor
London School of Hygiene and Tropical Medicine
Enrollment
1145
Locations
2
Primary Endpoint
Adherence
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2013
End Date
January 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Arms & Interventions

co-formulated Amodiaquine-Artesunate

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.

Intervention: amodiaquine-artesunate (AQAS) fixed-dose

artemether-lumefantrine

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

Intervention: Artemether-lumefantrine combination (AL) dispersable

Outcomes

Primary Outcomes

Adherence

Time Frame: 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.

Study Sites (2)

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