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.: PACTR201811755733759 Date of Approval: 08/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness and implementation of evriMED for adherence to treatment among TB patients in Kilimanjaro, Tanzania
Official scientific title Effectiveness and implementation of evriMED for adherence to treatment among TB patients in Kilimanjaro, Tanzania
Brief summary describing the background and objectives of the trial Adherence to TB treatment is challenging because of many factors. When inadequate, treatment may fail with the risk of developing multi drug resistant tuberculosis (MDR­TB). A promising way to intervene is Real Time Medication Monitoring (RTMM). Few studies have shown that RTMM is effective in improving adherence. A recently developed RTMM device, evriMED showed feasibility in China and India. However, in Tanzania, there may be challenges in implementing evriMED due to stigmatization, the appearance of the box, network and power access, accuracy and cost effectiveness which may have an implication for treatment outcomes. In this pragmatic cluster randomized trial, we will investigate the effectiveness of evriMED with reminder cues and tailored feedback on adherence to TB treatment in Kilimanjaro, Tanzania.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) REMINDTB
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 01/01/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 31/03/2020
Actual Last follow-up date 31/03/2021
Anticipated target sample size (number of participants) 660
Actual target sample size (number of participants) 507
Recruitment status Completed
Publication URL https://theunion.org/sites/default/files/2021-10/UNION2021_Abstracts_High.pdf
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 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 EVRIMED SIX MONTHS REAL TIME MEDICATION MONITORING 330
Control Group STANDARD CARE SIX MONTHS STANDARD CARE ACCORDING TO TANZANIAN GUIDELINES 330 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Diagnosed drug-susceptible TB patients (smear positive and symptom based) • Attending care at any of the TB treatment centers in Kilimanjaro region • Age between 18 and 65 • Living in Kilimanjaro Region • Willing to use the evriMED-device • Willing to come to the clinic according to standard care • Able to read and understand SMS • Able to understand and willing to sign the informed consent document • Participating in other trials • Previously Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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
No 01/10/2018 CRERC
Ethics Committee Address
Street address City Postal code Country
SOIKOINE ROAD MOSHI 0000 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/10/2018 NATHREC
Ethics Committee Address
Street address City Postal code Country
SCIENCE STREET DAR ES SALAAM 0000 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to treatment 2, 5, 6 MONTHS
Secondary Outcome STIGMATIZATION MONTH 2,5,6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KILIMANJARO REGION MAWENZI STREET MOSHI Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
STOP TB PARTNERSHIP Chemin du Pommier 40 GENEVA Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KILIMANJARO CLINICAL RESEARCH INSTITUTE SOKOINE ROAD MOSHI 0000 Tanzania Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
ROB AARNOUTSE GEERT GROOTEPLEIN 21 NIJMEGEN Netherlands
PYTHIA NIEUWKERK MEIBERGDREEF 9 AMSTERDAM 0000 Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MARION SUMARI DE BOER M.SUMARI@KCRI.AC.TZ +255754331948 SOKOINE ROAD
City Postal code Country Position/Affiliation
MOSHI Tanzania SENIOR RESEARCHER IN KILIMANJARO CLINICAL RESEARCH INSTITUTE
Role Name Email Phone Street address
Public Enquiries PRISCA NJAU P.NJAU@KCRI.AC.TZ +255272754201 SOKOINE ROAD
City Postal code Country Position/Affiliation
MOSHI Tanzania ADMINISTRATOR
Role Name Email Phone Street address
Scientific Enquiries Kennedy Ngowi k.ngowi@kcri.ac.tz +255758048649 PO Box 2236
City Postal code Country Position/Affiliation
Moshi Tanzania Post Doc Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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