Malaria Clinical Trial
Official title:
Adherence to Artemisinin-Based Combination Therapy (ACT) for the Treatment of Malaria in Sierra Leone
Verified date | January 2018 |
Source | London School of Hygiene and Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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: |
Country | Name | City | State |
---|---|---|---|
Sierra Leone | George Brook Health Center | Freetown | |
Sierra Leone | Ross Road Health Facility | Freetown |
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 |
Sierra Leone,
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 |
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