Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202211877150970 Date of Approval: 02/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title 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 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 .
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
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
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mobile DOTS 6 months for a patient Mobile DOTS‘ experiment, shortly ‘mDOTS‘, is a strategy that transfers the mandate of DOTS service provision from professional healthcare providers to nonprofessional DOTS providers who will be identified from the community, and then who will be trained, will receive anti-TB drugs and hence will be equipped to provide DOTS services. We aim the engagement of prominent village members as mobile DOTS providers will help to trace defaulters immediately and optimize treatment compliance in a pastoralist setting where the standard DOTS approach has been awkward to implement over a couple of decades. This study is designed as a small scale non-randomized, single-arm experiment to check the effectiveness of “Mobile DOTS“ strategy designed to improve TB treatment compliance and outcomes for mobile pastoralist patients. 121
Control Group Mobile DOTS 6 months for each patient Patients receiving the standard TB treatment through the standard DOTS strategy 121 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Mobile pastoralists who have confirmed TB (any form) • Who are newly diagnosed TB patients yet to initiate anti-TB treatment • Who are above or equal to 18 years old, mobile pastoralist (nomad) in livelihood • Who do not have access to TB services within 2 hours of walking distance • Patients with drug resistant/MDR/XDR TB • Patients who have poor health condition Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/03/2021 Jigjiga University Research Ethics Review Committtee
Ethics Committee Address
Street address City Postal code Country
Jigjiga University Jigjiga 1020 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Treatment compliance during the trial
Primary Outcome treatment outcome end of trial
Secondary Outcome community engagement end of trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Karamara hospital 06 Jigjiga Jigjiga Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jigjiga One Health Initiative Jigjiga University Jigjiga 1020 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jigjiga University Jigjiga University Jigjiga Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Swiss Tropical and Public Health Institute Kreuzstrasse 2 4123 Allschwil Basel Switzerland
Armauer Hansen Research Institute Ayer Tena Addis Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fentabil Getnet b.infen4ever@gmail.com +251913289380 Jigjiga university
City Postal code Country Position/Affiliation
Jigjiga Ethiopia Assistant professor
Role Name Email Phone Street address
Public Enquiries Rea Tschopp rea.tschopp@swisstph.ch +251911427021 Old Airport
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Senior Epidemiologist
Role Name Email Phone Street address
Scientific Enquiries Jakob Zinsstag jakob.zinsstag@swisstph.ch +41612848139 Kreuzstrasse 2 4123 Allschwil
City Postal code Country Position/Affiliation
Basel Switzerland professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study findings will be submitted for peer-reviewed publication. Anonymized and de-identified data will be shared along side with scientific manuscript submission. Study Protocol End of the study reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information