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.: PACTR201806003352147 Date of Approval: 27/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Remote Observed Therapy
Official scientific title Impact of Digital Health for Adherence Enhancement in Tuberculosis Therapy
Brief summary describing the background and objectives of the trial A major factor limiting the effectiveness of direct observed therapy (DOT) is high costs, which includes staff salaries, transportation and maintenance of car fleets. Also factors such as work schedule, school schedule and privacy concerns on part of the patients also pose a challenge to DOT success rate. WHO proposed a 90% reduction in TB deaths and an 80% reduction in new cases by 2030. To achieve this in Nigeria, Vassal and Mustapha, 2015, in their white paper reported a spending of close to N81billion (eighty-one billion naira) yearly to increase detection rates, strengthen primary health care provision and treat many more patients. Video observed therapy (VOT) can; minimize public health resources (reducing travel costs and time for staff and patients), reduce potential transmission to caregiver through prolong visual contact, increase privacy for patients, more convenient and less intrusive to patients. Though VOT is feasible and acceptable to patients in some developed countries, these may not be applicable to developing countries like Nigeria with high TB burden. The study aims to improve TB patient treatment adherence in Nigeria with the use of VOT. Specific Objectives 1. To develop NimCure application to improve adherence to TB anti-tuberculosis treatment by assuring 90% compliance. 2. To compare the treatment completion rate between VOT and DOT in monitoring patients¿ adherence to TB treatment. 3. To evaluate liver and kidney function markers of TB patients on anti-tuberculosis drug.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) NimCure
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Tuberculosis
Purpose of the trial Supportive care
Anticipated trial start date 18/06/2018
Actual trial start date 08/11/2018
Anticipated date of last follow up 11/06/2019
Actual Last follow-up date 30/11/2019
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status Not yet recruiting
Publication URL https://cchubnigeria.com/nimcure/
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group remote observed therapy daily 6 month Use of NimCure digital application 35
Control Group Remote observed therapy daily 6 months Control group will not use the app 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(a) Confirmed TB patients of not less than 15 years of age, receiving a regimen containing only oral medications, completed at least two weeks of DOT. (b) Demonstrate proficiency in using a smart phone after 1 or 2 training sessions. (c) Accurately identify each medication and self -administered by mouth. (d) Communicate in English or in a language spoken by available observers. (e) Have access to a private area that support patient confidentiality in the observation environmen (a) Patients with current or prior diagnosis of multidrug resistant (MDR) - TB or a severe mental illness. (b) Patients with disabilities that prevent full participation e.g. vision or hearing impaired. (c) Patients who experience adverse reaction(s) to prescribed medication (d) Patients with low adherence rate on DOT. (e) Patients at risk for hepatic complications. (f) Pediatric patients and (g) Homeless patients. 15 Year(s) 100 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 13/04/2018 Institutional Review Board, NIMR
Ethics Committee Address
Street address City Postal code Country
6, Edmund Crescent, Yaba Lagos 101212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of patients completing all doses of self-administered treatment during the study period, according to pill count by NimCure digital application Reviewed Daily Analyse Monthly
Secondary Outcome The proportion of videos uploaded as scheduled, and the proportion of patients discontinuing using VOT. Reviewed daily Analyse Monthly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tuberculosis Reference Centre, Nigerian Institute of Medical Research, NIMR 6, Edmund Crescent, Off Muritala Muhammed Way, Yaba Lagos 101212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nigerian Institute of Medical Research 6, Edmund Crescent, Off Muritala Muhammed Way, Yaba Lagos 101212 Nigeria
Co-creation Hub Nigeria 6th Floor, 294 Herbert Macaulay Way, Yaba Lagos 101212 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Co-creation Hub Nigeria 6th Floor, 294 Herbert Macaulay Way, Yaba Lagos 101212 Nigeria Commercial Sector/Industry
Secondary Sponsor Co-creation Hub Nigeria 6th Floor, 294 Herbert Macaulay Way, Yaba Lagos 101212 Nigeria Commercial Sector/Industry
Primary Sponsor Nigerian Institute of Medical Research 6, Edmund Crescent, Off Muritala Muhammed Way, Yaba Lagos 101212 Nigeria Hospital
Primary Sponsor Nigerian Institute of Medical Research 6, Edmund Crescent, Off Muritala Muhammed Way, Yaba Lagos 101212 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Tijani Bosun 6th Floor, 294 Herbert Macaulay Way, Yaba Lagos 101212 Nigeria
Gambari Aisha 6, Edmund Crescent, Off Muritala Muhammed Way, Yaba Lagos 101212 Nigeria
David Agatha N 6, Edmund Crescent, Off Muritala Muhammed Way, Yaba Lagos 101212 Nigeria
Audu Rosemary A. 6, Edmund Crescent, Off Muritala Muhammed Way, Yaba Lagos 101212 Nigeria
Oladele Dave 6, Edmund Crescent, Off Muritala Muhammed Way, Yaba Lagos 101212 Nigeria
Adesesan Adesegun 6, Edmund Crescent, Off Muritala Muhammed Way, Yaba Lagos 101212 Nigeria
Odewale Ebenezer 6, Edmund Crescent, Off Muritala Muhammed Way, Yaba Lagos 101212 Nigeria
Okoli Leona 6, Edmund Crescent, Off Muritala Muhammed Way, Yaba Lagos 101212 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olufemi Samuel Amoo os.amoo@nimr.gov.ng 2348033367441 6, Edmund Crescent, Yaba
City Postal code Country Position/Affiliation
Lagos 101212 Nigeria Research Fellow/NIMR
Role Name Email Phone Street address
Public Enquiries Aisha Gambari ayeeshagambari@gmail.com 08033183227 6, EdmondCrescent, Yaba
City Postal code Country Position/Affiliation
Yaba 101212 Nigeria Scientific Officer (Project)/NIMR
Role Name Email Phone Street address
Scientific Enquiries Adesegun Adesesan segunadesesan@yahoo.co.uk 2348062222624 6, Edmund Crescent, Yaba
City Postal code Country Position/Affiliation
Yaba 101212 Nigeria Medical Laboratory Scientist/NIMR
REPORTING
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