Adherence to Antimalarial Drugs in Sierra Leone

NCT01967472 | Completed

• 1 other identifier: SL-ACT-01
• Study Type: interventional
• Target: 1,145
• Locations: 1 country
• Sites: 2

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 4

Study Arms (2)

co-formulated Amodiaquine-Artesunate

ACTIVE COMPARATOR

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

artemether-lumefantrine

ACTIVE COMPARATOR

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

Interventions

amodiaquine-artesunate (AQAS) fixed-dose DRUG

Also known as: coarsucam, winthrop, co-formulated

co-formulated Amodiaquine-Artesunate

Artemether-lumefantrine combination (AL) dispersable DRUG

Also known as: coartem, AL, locally all Artemether-lumefantrine called 'lokmal'

artemether-lumefantrine

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• National Malaria Control Program, Ministry of Health and Sanitation: collaborator
• Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation: collaborator

Study Sites (2)

George Brook Health Center

Freetown, Sierra Leone

Location

Ross Road Health Facility

Freetown, Sierra Leone

Location

Related Publications (1)

• 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.

  PMID: 29866192 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

amodiaquine, artesunate drug combination; Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Kristin Banek

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: September 16, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 11, 2018

Record last verified: 2018-01

Locations

SI (2)