Adherence to Antimalarial Drugs in Sierra Leone

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967472
• Other study ID #: SL-ACT-01
• Status: Completed
• Phase: N/A
• First received: October 18, 2013
• Last updated: January 10, 2018
• Start date: September 16, 2013
• Est. completion date: January 2014

Study information

• Verified date: January 2018
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1145
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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:

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• amodiaquine-artesunate (AQAS) fixed-dose

• Artemether-lumefantrine combination (AL) dispersable

Locations

Country	Name	City	State
Sierra Leone	George Brook Health Center	Freetown
Sierra Leone	Ross Road Health Facility	Freetown

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Sierra Leone, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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