Adherence to Antimalarial Drugs in Sierra Leone
Primary Purpose
Malaria
Status
Completed
Phase
Not Applicable
Locations
Sierra Leone
Study Type
Interventional
Intervention
amodiaquine-artesunate (AQAS) fixed-dose
Artemether-lumefantrine combination (AL) dispersable
Sponsored by
About this trial
This is an interventional treatment trial for Malaria
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:
-
Sites / Locations
- George Brook Health Center
- Ross Road Health Facility
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
co-formulated Amodiaquine-Artesunate
artemether-lumefantrine
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Adherence
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01967472
First Posted
October 18, 2013
Last Updated
January 10, 2018
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
National Malaria Control Program, Ministry of Health and Sanitation, Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
1. Study Identification
Unique Protocol Identification Number
NCT01967472
Brief Title
Adherence to Antimalarial Drugs in Sierra Leone
Official Title
Adherence to Artemisinin-Based Combination Therapy (ACT) for the Treatment of Malaria in Sierra Leone
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 16, 2013 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
National Malaria Control Program, Ministry of Health and Sanitation, Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
co-formulated Amodiaquine-Artesunate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
artemether-lumefantrine
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
amodiaquine-artesunate (AQAS) fixed-dose
Other Intervention Name(s)
coarsucam, winthrop, co-formulated
Intervention Type
Drug
Intervention Name(s)
Artemether-lumefantrine combination (AL) dispersable
Other Intervention Name(s)
coartem, AL, locally all Artemether-lumefantrine called 'lokmal'
Primary Outcome Measure Information:
Title
Adherence
Description
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.
Time Frame
Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Banek
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Brook Health Center
City
Freetown
Country
Sierra Leone
Facility Name
Ross Road Health Facility
City
Freetown
Country
Sierra Leone
12. IPD Sharing Statement
Citations:
PubMed Identifier
29866192
Citation
Banek K, Webb EL, Smith SJ, Chandramohan D, Staedke SG. Adherence to treatment with artemether-lumefantrine or amodiaquine-artesunate for uncomplicated malaria in children in Sierra Leone: a randomized trial. Malar J. 2018 Jun 4;17(1):222. doi: 10.1186/s12936-018-2370-x.
Results Reference
derived
Learn more about this trial
Adherence to Antimalarial Drugs in Sierra Leone
We'll reach out to this number within 24 hrs