Trial no.:
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PACTR202211877150970 |
Date of Approval:
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02/11/2022 |
Trial Status:
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Retrospective registration - This trial was registered after enrolment of the first participant |
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TRIAL DESCRIPTION |
Public title
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mDOTS |
Official scientific title |
Adaptation of Mobile Directly Observed Treatment-Short Course for Pastoralist Tuberculosis patients in Ethiopia |
Brief summary describing the background
and objectives of the trial
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Background: The seasonal mobility of the pastoralists for pasture and water has been the ever existing challenge to the delivery of health services. Due to a lack of a care delivery system that is customized to the mobility of nomads, the Directly Observed Therapy-Short course (DOTS) for tuberculosis (TB), patients are mandated to attend health facilities every day, is facing high defaulting and unfavorable outcomes. Strategies that can accommodate the mobility of pastoralists are indispensable. In response to this challenge, we have designed a tailored approach called ‘mobile DOTS’ for pastoralist TB patients in Ethiopia. The ‘Mobile DOTS’ strategy transfers the mandate of DOTS provision from professional healthcare providers to nonprofessional community leaders (religious or traditional healers) who will be trained, collect TB drugs and hence are equipped to provide DOTS at their home in the closest vicinity of patients.Therefore, the aim of this trial is to experiment the effectiveness of ‘mobile DOTS strategy’ in improving compliance/adherence to treatment and outcomes among pastoralist TB patients in Somali Region, Ethiopia
This will be a small scale non-randomized single arm experiment on 121 pastoralist TB patients in Somali Regional of Ethiopia. The effectiveness of the experiment will be evaluated using treatment adherence/compliance and success rates during the course and at completion of treatment by the strategy. National/global targets and the existing treatment outcomes will be used as reference values to determine trial thresholds and acceptance. The scalability and practicability of the strategy will be evaluated using in-depth interviews with patients, mobile DOTS providers and healthcare providers participated in the trial .
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Type of trial |
CCT |
Acronym (If the trial has an acronym then please provide) |
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Disease(s) or condition(s) being studied |
Infections and Infestations |
Sub-Disease(s) or condition(s) being studied |
Tuberculosis |
Purpose of the trial |
Adaptation of standard treatment strategy |
Anticipated trial start date |
01/03/2021 |
Actual trial start date |
01/01/2022 |
Anticipated date of last follow up |
31/03/2022 |
Actual Last follow-up date |
30/04/2023 |
Anticipated target sample size (number of participants) |
121 |
Actual target sample size (number of participants) |
121 |
Recruitment status |
Recruiting |
Publication URL |
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