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OpenTrials
Completed

NCT Number: NCT01967472

Adherence to Antimalarial Drugs in Sierra Leone

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.

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Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Brook Health Center, Freetown, Sierra Leone

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

amodiaquine-artesunate (AQAS) fixed-dose

Drug

Other names: coarsucam, winthrop, co-formulated

Artemether-lumefantrine combination (AL) dispersable

Drug

Other names: coartem, AL, locally all Artemether-lumefantrine called 'lokmal'

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • National Malaria Control Program
  • Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Oct 23, 2013
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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