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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
Sponsor:
Collaborators:
National Malaria Control Program, Ministry of Health and Sanitation
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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.


Condition or disease Intervention/treatment Phase
Malaria Drug: amodiaquine-artesunate (AQAS) fixed-dose Drug: Artemether-lumefantrine combination (AL) dispersable Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
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'




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

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


Locations
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Sierra Leone
George Brook Health Center
Freetown, Sierra Leone
Ross Road Health Facility
Freetown, Sierra Leone
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
National Malaria Control Program, Ministry of Health and Sanitation
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Investigators
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Principal Investigator: Kristin Banek London School of Hygiene and Tropical Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01967472     History of Changes
Other Study ID Numbers: SL-ACT-01
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Lumefantrine
Artemether
Artemether, Lumefantrine Drug Combination
Amodiaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics