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.: PACTR202101914895981 Date of Approval: 25/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Initial Loss to Follow Up Among Tuberculosis Patients: The Role of Ward-Based Outreach Teams and Short Message Service (SMS) Technology
Official scientific title Initial Loss to Follow Up Among Tuberculosis Patients: The Role of Ward-Based Outreach Teams and Short Message Service (SMS) Technology
Brief summary describing the background and objectives of the trial Tuberculosis (TB) is a problem in South Africa. Initial loss to follow up (LTFU) among TB patients is high varying between 14.9% and 18%. Some of the reasons for this are: lack of proper communication between patient and staff on next steps after testing, not aware that results are ready; and other competing priorities. Receiving reminder messages that result is ready is an intervention that can be explored to reduce initial LTFU. This can be through either receiving a note from the Ward-Based Outreach Teams (WBOTs) or via short message service (SMS) advising the patient to collect test result at the facility. This proposal aims to assess the effectiveness of WBOTs or SMS technology in reducing TB initial LTFU. Aim The main aim is to assess the effectiveness of WBOTs and/or SMS technology in reducing initial LTFU among TB patients. Objectives 1. To assess the effectiveness of WBOTs in reducing initial LTFU among TB patients. 2. To assess the effectiveness of SMS technology in reducing initial LTFU among TB patients Study Design: This will be an Individual Randomised Controlled Trial. Two interventions (enhanced WBOTs and SMS technology) will be tested using the same population. Therefore, there will be 3 arms at the different sites/ facilities (each site implementing all 3 arms of the study). The intervention “Enhanced WBOTs” refers to WBOTs conducting delivering paper note reminders to patients whose test results are ready in addition to their current scope of work (12). SMS intervention will entail sending reminder SMS messages to TB patients as soon as results are received at the facility. Arm A: Standard of care (no SMS technology and no enhanced WBOTs) Arm B: SMS technology Arm C: Enhanced WBOTs Study setting: Inner-city Johannesburg metropolitan area in South Africa occupies an area of 1645km2 and has a population of 4.4 million (32). WBOTs focus on health promotion, disease prevention and adherence support (12,15). Enhanced WBOTs will not only focus on tho
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 Use of SMS messaging and ward based outreach teams to reduce initial lost to follow up
Anticipated trial start date 15/01/2018
Actual trial start date 10/09/2018
Anticipated date of last follow up 28/08/2020
Actual Last follow-up date 26/03/2020
Anticipated target sample size (number of participants) 312
Actual target sample size (number of participants) 314
Recruitment status Completed
Publication URL https://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-019-4757-3
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 Permuted block randomization 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 SMS One reminder SMS message Once off This group will have the SMS technology as the intervention. As per current standard of practice, patients with presumptive TB submitting sputum will be asked for their contact details including mobile phone numbers. This information will be entered in the TB Case Identification Register as well as in the study book. The patients will submit sputum and asked to collect test result after 2 days. Patients with positive test results will receive SMS messages telling them that their results are ready at the facility. The TB patients’ names will be allocated to this arm if they are allocated the letter “B” from the randomization block. The TB treatment initiation register at the clinic will be checked regularly for names of the patients randomized to this arm for a period of 4 weeks. The ones with positive TB test but not initiated on treatment will be noted. 104
Experimental Group Paper slip message via ward based outreach teams One paper slip reminder message Once off As per current standard of practice, patients with presumptive TB submitting sputum will be asked for their contact details including mobile phone numbers. This information will be entered in the TB Case Identification Register as well as in the study book. The patients will be informed that results of the test will be ready after about 2 days when they can go to the clinic to collect them. The patients’ names who test positive for TB and allocated to this arm will be given to the WBOTs. The patients will be allocated to this arm if they are letter “C” from the randomization block. The WBOTs will then deliver a paper note advising the patient to go to the clinic to collect TB results. In the event that the WBOTs do not find the patient at the named address, they will leave the paper note. Treatment initiation registers at the clinics will be checked regularly for a period of 4 weeks. The ones with positive TB test result but not initiated on treatment will be noted. 104
Control Group Standard of care No reminder message No intervention As per current standard of practice, patients with presumptive TB submitting sputum will be asked for their contact details including mobile phone numbers. This information will be entered in the TB Case Identification Register as well as in the study book. The patients will submit sputum and asked to collect test result after 2 days. The TB Case Identification Register at the clinic will be checked regularly to check the results of the patients enrolled in the study. The names of those with a positive result will be checked for in the TB Treatment initiation register. The TB patients will be allocated to this arm if they are allocated the letter “A” from the randomization block. After 4 weeks, the ones with positive TB test result but not initiated on treatment will be noted. 104 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 18 years old and above Not yet diagnosed with TB Productive cough of more than 24 hours Previous TB Children less than 18 years old Already on TB treatment 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) 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
Yes 23/10/2017 University of Witwatersrand Human Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Cnr York Road and 29 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Initial loss to follow up 28 days
Primary Outcome Treatment initiation Any time within 28 days
Secondary Outcome Time to treatment initiation Duration before treatment initiation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hillbrow clinic Klein St Johannesburg 2000 South Africa
Lenasia South CHC 3 Cosmos Street Johannesburg 1829 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Consortium for Advanced Research Training in Africa CARTA APHRC Campus, 2nd Floor, Manga Close, Off Kirawa Road Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Consortium for Advanced Research Training in Africa APHRC Campus, 2nd Floor, Manga Close, Off Kirawa Road Nairobi Kenya PhD Fellowship
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Judith Mwansa Kambafwile jmwansa@cartafrica.org +27739217403 15 Bruwer Street, Edenglen
City Postal code Country Position/Affiliation
Johannesburg 1613 South Africa Researcher University of Witwatersrand
Role Name Email Phone Street address
Public Enquiries Judith Mwansa Kambafwile judy.mwansa@gmail.com +27739217403 15 Bruwer Street, Edenglen
City Postal code Country Position/Affiliation
Johannesburg 1613 South Africa University of Witwatersrand
Role Name Email Phone Street address
Scientific Enquiries Charles Chasela charles.chasela@wits.ac.za +27117172312 60 York Rd, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Associate Professor University of Witwatersrand
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data has patient identifying information and therefore will not be publicly available due to confidentiality agreements with the participants. However, contact with corresponding author can be made for data access. Data will be available to researchers with proposals approved by respective IRB committees Study Protocol 12 months after publication Data will be available to researchers with proposals approved by respective IRB committees
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