Extrait

Background and study aims Artemisinin-resistant malaria has been detected in south East Asia, with possible malaria cases in Western Cambodia, Western Thailand and Myanmar. This poses a major global public health threat, with the greatest potential effects in sub-Saharan Africa where the disease burden is greatest and systems for monitoring resistance to malaria treatment and control of malaria are weakest. A public health disaster is imminent, unless early warning and early detection measures are urgently set up. Poor patient adherence to treatment and drug misuse are among the causes of resistance. Recent evidence suggests that the traditional approaches (provider counselling and caregiver aids) for improving patient adherence in routine settings are not enough. There is a need to investigate new approaches to address this problem. Mobile phone short messaging services (SMS) have been investigated in health information reporting, provider performance, drug and diagnostic stock management and patient adherence to treatment for chronic diseases. However, their role in improving patients’ adherence and post-treatment review for acute diseases has not been investigated. The aim of this study is to investigate if text messaging can improve patient adherence to malaria treatment and to find out whether text messaging can bring back more patients for post-treatment review. Who can participate? Caregivers of male and female children aged < 5 years old with uncomplicated malaria. What does the study involve? Participants will be randomly allocated to one of two study groups: 1) the current standard of care based on provider counselling and health education alone, and 2) the current standard of care plus SMS reminders. Within each group participants will be further equally allocated to three different categories. Category 1 will be visited at home on day 1 of follow-up to measure appropriate timing of the second Artemether-Lumefantribe (AL) dose; category 2 will be visited on day 2 to measure adherence and timing of AL doses 2, 3 and 4; category 3 will be visited on day 3 to measure adherence for the full AL course. What are the possible benefits and risks of participating? If successful, the results of the planned study could improve malaria case management and offer new strategies for mitigation of antimalarial drug resistance in Africa. This is a minimal risk study, the text messages will be designed in English and local languages (Dholuo and Kiswahili), and except for small needle pricks to get blood samples we do not anticipate major risks to the safety of patients in the study. Home visits are likely to cause some inconvenience but we will ensure that they are fairly convenient to the study participants. Psychological risks could occur if caregivers receive the wrong text messages or receive text messages when the patient has died. We will limit such risks by carefully designing the intervention and pre-testing it, and we will conduct the study among patients with uncomplicated malaria where the risk of death is lower. There are no other risks, costs or individual benefits for those involved in the study, beyond getting health care. Where is the study run from? The study will be conducted at four sites in the greater Bondo area in Nyanza Province, Kenya, at Bondo and Madiany District Hospitals representing two urban areas and Ndori and Got Agulu Health Centres representing two rural areas. When is the study starting and how long is it expected to run for? April 2014 to September 2015 Who is funding the study? Medical Research Council (UK) Who is the main contact? Dr Ambrose Talisuna [email protected]

Critère d'inclusion

• Malaria treatment adherence and post treatment review

Liens

• isrctn
• ictrp