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.: PACTR202002831201865 Date of Approval: 18/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mobile-assisted Medication Adherence Support (Ma-MAS) Intervention for Tuberculosis Patients in Addis Ababa, Ethiopia.
Official scientific title Mobile-assisted Medication Adherence Support (Ma-MAS) Intervention among Tuberculosis Patients in Addis Ababa, Ethiopia; Randomized Control Trial (RCT)
Brief summary describing the background and objectives of the trial Non-adherence to TB treatment is a risk factor for further transmission, treatment failure, relapse, acquired multi-drug resistance or extensively drug-resistant tuberculosis and death. In Ethiopia, non-adherence is a serious threat to TB prevention and control programs. There are various factors affecting non-adherence behaviour. Lack of information and skill for self-management, motivation, and self-efficacy are the major barriers to adherence. The widespread expansion of mobile phones provides opportunities to address challenges related to non-adherence, as mobile health can facilitate direct communication between health care providers and patients through using SMS and voice phone calls. However, the existing evidence is inconsistent about the effect of SMS text on TB treatment adherence and outcomes. Because the evidence on mobile interventions is equivocal, there is a reason to try and establish it more rigorously, by developing the SMS text intervention systematically with evidence-based and conducting the trial with strong measurement methods. Thus, this study aims to investigate the effect of mobile-assisted adherence support intervention using SMS text and Phone calls on TB medication adherence.
Type of trial RCT
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 Behavioural Intervention
Anticipated trial start date 31/03/2021
Actual trial start date 27/04/2021
Anticipated date of last follow up 31/07/2021
Actual Last follow-up date 29/10/2021
Anticipated target sample size (number of participants) 186
Actual target sample size (number of participants)
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SMS text plus phone calls A daily SMS text and weekly phone calls for medication intake and medication refill visits reminders 2 months Arm-1 (intervention) group participants will receive a daily SMS text and weekly phone calls for medication intake and medication refill visit reminders 93
Control Group Non daily DOT alone 2 months Arm-2 (control) group participants will receive the same routine standard treatment care as the intervention group, but not receive the additional intervention. Patients in the control group will be followed for an equal period as the intervention group during the continuation phase of treatment. 93 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be included into the randomized control trial (RCT) • participants must be enrolled in a primary public health facility for anti-TB treatment and have attained their first two months of the intensive phase of treatment • participants must be aged 18 years and above • participants must be able to read and understand SMS text that is written in the national official language (Amharic) of Ethiopia • participants must have their own mobile phone, or • participants who do not have a mobile phone can be included if they have a shared mobile phone in the household with a collaborative agreement; (i.e. a voluntary agreement between the patient and family member living in the same household). Participants will be excluded from the randomized trial if they meet the following conditions: Patients whose anti-tuberculosis treatment prescribed for more than six months of treatment. Patients who unable to read and speak the national official language of Ethiopia. Patients who enrolled or agreed to enroll in another trial study as the same time with this study. 80 and over: 80+ Year,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 08/04/2020 Southern Adelaide Clinical Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Flinders Medical centre, Bedford Park, South Australia Adelaide 5042 Australia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome TB medication adherence measured by IsoScreen test At the random point of 4 and 8 weeks of intervention
Secondary Outcome TB medication adherence measured by ACTG, VAS and clinical attendance At baseline and end of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Primary health facilities Addis Ababa Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Flinders University Sturt Rd, Bedford Park SA 5042 Adelaide Australia
Ambo University Ambo 01 Ambo Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Flinders University Sturt Rd, Bedford Park SA 5042 Adelaide Australia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zekariyas Nezenega neze0002@flinders.edu.au +61449962325 40 Cheltenham St, Highgate SA
City Postal code Country Position/Affiliation
Adelaide Australia PhD Candidate
Role Name Email Phone Street address
Scientific Enquiries Anthony Maeder anthony.maeder@flinders.edu.au 61882013107 1284 South Rd, Tonsley SA
City Postal code Country Position/Affiliation
Adelaide Australia Professor of Digital Health Systems in Flinders University
Role Name Email Phone Street address
Public Enquiries Yohannes Dr yoha2wok@yahoo.com 251911384599 Addis Ababa Health Bureau
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Addis Ababa Health Bureau Human Research Ethics committee coordinator
Role Name Email Phone Street address
Scientific Enquiries Lua Perimal Lewis lua.perimal-lewis@flinders.edu.au +61882012069 1284 South Rd, Tonsley SA
City Postal code Country Position/Affiliation
Adelaide Australia Senior Research Fellow in Digital Health in Flinders University
Role Name Email Phone Street address
Scientific Enquiries Paul Arbon Paul.arbon@flinders.edu.au +61418856560 Sturt Road Bedford Park
City Postal code Country Position/Affiliation
Adelaide Australia Matthew Flinders Distinguished Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results or link to summary results will be included within the trials registration records. Study Protocol Within 12 months of the study completion date The study protocol and summary of results will be an open access.
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