Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial

Abstract

BackgroundPodoconiosis is one of the forgotten types of leg swelling (elephantiasis) in the tropics. Unlike the other, better-known types of leg swelling, podoconiosis is not caused by any parasite, virus or bacterium, but by an abnormal reaction to minerals found in the clay soils of some tropical highland areas. Non-governmental Organizations (NGOs) have been responsible for the development of simple treatment methods without systematic evaluation of its effectiveness. It is essential that a large scale, fully controlled, pragmatic trial of the intervention is conducted. We aim to test the hypothesis that community-based treatment of podoconiosis lymphoedema reduces the frequency of acute dermatolymphangioadenitis episodes (‘acute attacks’) and improves other clinical, social and economic outcomes.Methods/DesignThis is a pragmatic, individually randomised controlled trial. We plan to randomly allocate 680 podoconiosis patients from the East Gojjam Zone in northern Ethiopia to one of two groups: ‘Standard Treatment’ or ‘Delayed Treatment’. Those randomised to standard treatment will receive the hygiene and foot-care intervention from May 2015 for one year, whereas those in the control arm will be followed through 2015 and be offered the intervention in 2016. The trial will be preceded by an economic context survey and a Rapid Ethical Assessment to identify optimal methods of conveying information about the trial and the approaches to obtaining informed consent preferred by the community. The primary outcome will be measured by recording patient recall and using a simple, patient-held diary that will be developed to record episodes of acute attacks. Adherence to treatment, clinical stage of disease, quality of life, disability and stigma will be considered secondary outcome measures. Other outcomes will include adverse events and economic productivity. Assessments will be made at baseline and at 3, 6, 9 and 12 months thereafter.DiscussionThe evidence is highly likely to inform implementation of the new master plan for integrated control of Neglected Tropical Diseases (NTDs), in which podoconiosis is identified as one of eight NTDs prioritised for control. Potentially, an estimated 3 million patients in Ethiopia will therefore benefit from the results of this trial.Trial registrationInternational Standard Randomised Controlled Trial Number. Registration number: ISRCTN67805210. Date of registration: 24 January 2013.

Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study

“…In our study, therapeutic misconception was a big deal in rural resident participants, farmers, house wives and religious leaders. Most of the participants understand health research in terms of laboratory investigation to diagnose a disease, while others has explained research relating to land and agricultural farming, which coincides with other study findings[ 11 , 12 , 23 ]. This could be due to the fact that most of the people in Ethiopia are engaged in agriculture and have experience related to agricultural research and best practice expansion among farmers.…”

Soil iron and aluminium concentrations and feet hygiene as possible predictors of Podoconiosis occurrence in Kenya

“…Deliberate water, hygiene and sanitation (WASH) education and promotion should be extended to include feet in addition to hand hygiene in endemic areas in Kenya. Specific interventions are currently being tried in the field in Ethiopia including ‘foot hygiene’ [ 46 ], hence similar measures need to be introduced in Kenya.…”

Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment

“…The primary object of the trial is to test the hypothesis that community-based treatment of podoconiosis lymphoedema reduces the frequency of acute dermatolymphangioadenitis episodes (ADLA, ‘acute attacks’) and improves other clinical, social and economic outcomes. In this study we aimed to explore optimal methods of conveying information about the trial and the approaches to obtaining informed consent preferred by the community in which the trial was to be carried out [ 19 ].…”