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Adherence to Antimalarial Drugs in Sierra Leone

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01967472
Enrollment
1145
Registered
2013-10-23
Start date
2013-09-16
Completion date
2014-01-31
Last updated
2018-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

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.

Interventions

DRUGamodiaquine-artesunate (AQAS) fixed-dose
DRUGArtemether-lumefantrine combination (AL) dispersable

Sponsors

National Malaria Control Program, Ministry of Health and Sanitation
CollaboratorUNKNOWN
Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
CollaboratorUNKNOWN
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
AdherenceDay 4Adherence 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.

Countries

Sierra Leone

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026