Adherence to Antimalarial Drugs in Sierra Leone
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|ClinicalTrials.gov Identifier: NCT01967472|
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : January 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: amodiaquine-artesunate (AQAS) fixed-dose Drug: Artemether-lumefantrine combination (AL) dispersable||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1145 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adherence to Artemisinin-Based Combination Therapy (ACT) for the Treatment of Malaria in Sierra Leone|
|Actual Study Start Date :||September 16, 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
Active Comparator: 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.
Drug: amodiaquine-artesunate (AQAS) fixed-dose
Other Name: coarsucam, winthrop, co-formulated
Active Comparator: 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
Drug: Artemether-lumefantrine combination (AL) dispersable
Other Name: coartem, AL, locally all Artemether-lumefantrine called 'lokmal'
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967472
|George Brook Health Center|
|Freetown, Sierra Leone|
|Ross Road Health Facility|
|Freetown, Sierra Leone|
|Principal Investigator:||Kristin Banek||London School of Hygiene and Tropical Medicine|