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: www.pactr.org
Trial no.: PACTR202008776694999 Date of Approval: 11/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adherence Support Coalition to End TB: evaluation of digital adherence technologies for TB treatment in Ethiopia
Official scientific title Evaluation of digital adherence technologies for TB treatment in Ethiopia
Brief summary describing the background and objectives of the trial In 2017, an estimated 10 million people fell ill with tuberculosis (TB). There is an urgent need to optimize the use of new and existing tools to reach the global End TB goals. Non-adherence to treatment leads to increased unfavourable outcomes, relapse, drug-resistance, disease transmission and health system costs. The implementation of digital adherence technologies (DATs) has the potential to be a patient centred approach to improve TB treatment adherence across a range of settings in order to end TB as a public health problem. Therefore, we aim to implement and evaluate the impact and contextual factors of DAT systems (medication sleeve, smart pill box) with a differentiated response to patient care, among adult pulmonary TB participants in Ethiopia.
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 Treatment: Devices
Anticipated trial start date 05/10/2020
Actual trial start date 01/06/2021
Anticipated date of last follow up 04/10/2022
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 3900
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group EvriMed Device medical monitor and differentiated response to patient adherence 6 months Participants in facilities randomised to either of the two intervention arms will be offered a digital adherence technology (DAT) linked to the adherence platform for patient monitoring. Intervention arm 1 will use the EvriMed Device smart pill box. A display of the patient’s engagement with the DAT will be available daily, on a tablet provided to the health facility to enable health care providers to provide counselling and identify good and poor adherence, thus allowing for differentiated response to patient adherence. These intervention will be standardised across facilities in the intervention arms and includes data-driven support interventions like messaging educational reinforcements and reminders to participants and health care workers (HCWs). Patients using the smart pill box who do not have access to a mobile phone and who have missed doses documented on the platform will be contacted by HCWs either through home visits or the mobile phone of the treatment supporter, if appropriate. The unit of randomisation is health facility. In this arm there are 26 health facilities, with around 50 TB patients enrolled per facility. 1300
Experimental Group medication sleeves or label and differentiated response to patient adherence 6 months Participants in facilities randomised to either of the two intervention arms will be offered a digital adherence technology (DAT) linked to the adherence platform for patient monitoring. Intervention arm 2 will use medication sleeves/label. A display of the patient’s engagement with the DAT will be available daily, on a tablet provided to the health facility to enable health care providers to provide counselling and identify good and poor adherence, thus allowing for differentiated response to patient adherence. These intervention will be standardised across facilities in the intervention arms and includes data-driven support interventions like messaging educational reinforcements and reminders to participants and health care workers (HCWs). Patients in facilities randomised to medication sleeves who do not have access to a mobile phone will be offered the smart pill box instead. The unit of randomisation is health facility. In this arm there are 26 health facilities, with around 50 TB patients enrolled per facility. 1300
Control Group Standard of care 6 months Participants at standard of care facilities will utilize the standard of care in that facility, be it facility or home-based DOT. The National TB Protocol (NTP) specifies this standard of care is direct observation of medication intake during the intensive phase by a health worker or TB treatment supporter, at a health facility (hospital, health centre or health post), at patient’s workplace, residence institution or home. During the continuation phase the NTP specifies medication intake is under direct observation by a TB treatment supporter. Missed clinic appointments should result in a phone call to the patient and missing two consecutive clinic appointments should prompt a home visit by an HCW. These recommendations are likely to be applied variably. The unit of randomisation is health facility. In this arm there are 26 health facilities, with around 50 TB patients enrolled per facility. 1300 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults (≥18 years, male and female) with pulmonary DS-TB Adult with pulmonary DS-TB who are initiated on TB treatment using fixed dose combination (FDC) at the health facility Adult with pulmonary DS-TB who have provided informed consent. Patients who expect to leave the study area at any time during the treatment or follow up period Critically ill patients receiving in-patient care or palliative care 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) 90 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 23/03/2020 Observational and Interventions Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel Street, London WC1E 7HT London 19120 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of adult pulmonary DS-TB participants with unfavourable outcome, defined as poor end of treatment outcome (lost to follow-up, death or treatment failure) or treatment recurrence up to 6 months after the scheduled end of treatment (defined as restarting TB treatment or sputum culture positive 12 months after enrolment). Each intervention arm will be compared to the standard of care arm. up to 12 months after enrollment
Secondary Outcome The proportion of adult pulmonary DS-TB participants who have poor treatment outcome (lost to follow-up, death during treatment or treatment failure). Each intervention arm will be compared to the standard of care arm. up to 6 months after enrollment
Secondary Outcome The proportion of adult pulmonary DS-TB participants who are lost to follow-up during treatment. Each intervention arm will be compared to the standard of care arm. up to 6 months after enrollment
Secondary Outcome The proportion of adult pulmonary DS-TB participants with unfavourable outcome (comparing the two intervention arms). up to 12 months after enrollment
Secondary Outcome Patterns of longitudinal technology engagement in the intensive and continuation phases. over 6 months from enrollment
Secondary Outcome To describe the fidelity and characteristics associated with successful use of to the intervention among adult pulmonary DS-TB participants, including web-based platform usage statistics, technology failures or inability to engage with the DAT and cell phone access. over 6 months from enrollment
Secondary Outcome To describe the longitudinal technology engagement (smart pill box and video supported treatment) and interim treatment outcomes among DR-TB participants enrolled over 6 months from enrollment
Secondary Outcome To project the direct and indirect epidemiological impact of scale-up of (i) smart pill box and (ii) medication sleeve, with daily monitoring and differentiated response to patient adherence compared with the standard of care as measured by the change in unfavourable outcome in the intervention relative to the standard of care among adult pulmonary DS-TB participants Modelling impact over 50 years
Secondary Outcome To estimate the cost-effectiveness of the two interventions from a health system perspective compared to the standard of care among adult pulmonary DS-TB participants up to 12 months after enrollment
Secondary Outcome To explore the institutional feasibility and acceptability of implementing (i) smart pill box and (ii) medication sleeve for daily monitoring, with differentiated response to patient adherence in adult DS-TB and DR-TB participants (smart pill box only). up to 12 months after enrollment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
City Government of Addis Ababa Health Bureau St. Urael Addis Ababa Ethiopia
Oromia Health Bureau Sarbet Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Unitaid 1218 Grand-Saconnex Geneva Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KNCV Tuberculosis Foundation Maanweg 174, 2516 AB Den Haag Hague Netherlands Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
KNCV Tuberculosis Foundation in Ethiopia Bole subcity, kebele 03 Addis Ababa Ethiopia
London School of Hygiene and Tropical Medicine Keppel st London United Kingdom
National TB Program in Ethiopia Sudan street Addis Ababa Ethiopia
KNCV Tuberculosis Foundation the Hague Van Bylandt Huis - Benoordenhoutseweg 46 The Hague 2596 Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Katherine Fielding Katherine.Fielding@lshtm.ac.uk +442079272889 Keppel st
City Postal code Country Position/Affiliation
London United Kingdom PI
Role Name Email Phone Street address
Principal Investigator Taye Letta tayeletta@gmail.com +251115159653 sudan st
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia National TB and leprosy program coordinator
Role Name Email Phone Street address
Scientific Enquiries Amare Tadesse amare.tadesse@lshtm.ac.uk +251911635786 Bole subcity, kebel 03
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Trial Manager and co Investigator
Role Name Email Phone Street address
Public Enquiries Gediyon Teferra gediyon.teferra@kncvtbc.org +251116630145 Bole subcity
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Acting Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary of main findings or link to summary results will be shared. Study Protocol Within 12 months of study completion. Rules and regulations will be established describing the process of requesting, accessing and using data by any external institute or individual not mentioned in the national data policy and agreement. As a principle, only data from the ASCENT research database can be shared which, by definition, does not include person identifiable data.
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
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 11/08/2020 rephrased for clarification Experimental Group, 99DOTS medication sleeve and differentiated response to patient adherence, , 6 months, Participants in facilities randomised to either of the two intervention arms will be offered a digital adherence technology (DAT) linked to the adherence platform for patient monitoring. Intervention arm 2 will use 99DOTS medication sleeves. A display of the patient’s engagement with the DAT will be available daily, on a tablet provided to the health facility to enable health care providers to provide counselling and identify good and poor adherence, thus allowing for differentiated response to patient adherence. These intervention will be standardised across facilities in the intervention arms and includes data-driven support interventions like messaging educational reinforcements and reminders to participants and health care workers (HCWs). Patients in facilities randomised to medication sleeves who do not have access to a mobile phone will be offered the smart pill box instead. The unit of randomisation is health facility. In this arm there are 26 health facilities, with around 50 TB patients enrolled per facility., 1300,
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 11/08/2020 Updated information for recruitment center Public health facility, Addis Ababa and Oromia regions, Addis Ababa and Oromia, , Ethiopia City Government of Addis Ababa Health Bureau, St. Urael, Addis Ababa , , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 11/08/2020 Updated information for recruitment center Oromia Health Bureau, Sarbet, Addis Ababa, , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 11/08/2020 PACTR update No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 11/08/2020 PACTR update Summary of main findings or link to summary results will be shared.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 11/08/2020 PACTR update Within 12 months of study completion.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 11/08/2020 PACTR update Rules and regulations will be established describing the process of requesting, accessing and using data by any external institute or individual not mentioned in the national data policy and agreement. As a principle, only data from the ASCENT research database can be shared which, by definition, does not include person identifiable data.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 11/08/2020 PACTR update Study Protocol
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 25/05/2021 TB medication blister packages vary widely and were difficult to forecast. Therefore, the label approach was adopted instead of the 99 DOTS. Experimental Group, medication sleeves or label and differentiated response to patient adherence , , 6 months, Participants in facilities randomised to either of the two intervention arms will be offered a digital adherence technology (DAT) linked to the adherence platform for patient monitoring. Intervention arm 2 will use medication sleeves/label. A display of the patient’s engagement with the DAT will be available daily, on a tablet provided to the health facility to enable health care providers to provide counselling and identify good and poor adherence, thus allowing for differentiated response to patient adherence. These intervention will be standardised across facilities in the intervention arms and includes data-driven support interventions like messaging educational reinforcements and reminders to participants and health care workers (HCWs). Patients in facilities randomised to medication sleeves who do not have access to a mobile phone will be offered the smart pill box instead. The unit of randomisation is health facility. In this arm there are 26 health facilities, with around 50 TB patients enrolled per facility., 1300,
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 01/06/2021 Recruitment for actual trial started 01 Jun 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 01/06/2021 Last follow up for actual trial 31 May 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 01/06/2021 Recruitment for actual trial started Not yet recruiting Recruiting