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.: PACTR201812631160518 Date of Approval: 14/12/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Behavioural and Economic Analysis of TB Non-Initiation in Cape Town, South Africa
Official scientific title SMS Nudges as a Tool to Reduce Tuberculosis Treatment Delay and Pretreatment Loss to Follow-Up. A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial TB persists despite being relatively easy to detect and cure because the journey from the onset of symptoms to cure involves a series of steps, with patients being lost to follow-up at each stage and delays occurring among patients not lost to follow-up. One cause of drop-off and delay occurs when patients delay or avoid returning to clinic to get their test results and start treatment. We fielded two SMS interventions in three Cape Town clinics to see their effects on whether people returned to clinic, and how quickly. One was a simple reminder; the other aimed to overcome “optimism bias” by reminding people TB is curable and many millions die unnecessarily from it. Recruits were randomly assigned at the clinic level to a control group or one of the two SMS groups (1:4). In addition to estimating effects on the full sample, we also estimated effects on HIV-positive patients.
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: Drugs
Anticipated trial start date 01/08/2017
Actual trial start date 06/08/2018
Anticipated date of last follow up 31/03/2018
Actual Last follow-up date 31/03/2018
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants) 660
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 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 reminder 1 They received a single SMS reminder the evening before the participant needed to return to the facility to collect their test results. We sent SMS reminders over a period of 2 and a half months (one SMS per participant). The control group received no SMS reminder message. The first intervention group (SMS1) received a simple SMS reminder to return to the clinic to collect their TB test results. Clinic staff told patients to return in two (working) days’ time to get their results, and the SMS was sent via a bulk SMS service around 6-7pm the evening before. The message in English read “Don't forget to collect your results from the clinic tomorrow.” The second intervention group (SMS2) received a longer SMS message reminding them to return to the clinic, and that people die unnecessarily from TB because it can be cured. The message in English read: “Don't forget to collect your results from the clinic tomorrow. 96,000 South Africans die every year from TB. This should not be – TB can be cured”. Both messages were translated into and sent in Xhosa for those who had said in their baseline interview that this was their native language. The records of the bulk SMS service were checked to make sure that the SMS messages were delivered to the patient’s mobile phone, that the correct SMS was sent, and that patients in the control group did not inadvertently receive a message. 257
Control Group Control Group This group received the default case management after testing with no intervention (SMS reminder). The study lasted for 2 and a half months The control group received no intervention 150 Dose Comparison
Experimental Group SMS reminder 2 Half of the experimental sample received a simple reminder plus a second sentence added to their reminder, saying "TB is curable, yet 96 000 TB patients in South Africa die unnecessarily every year”. The study was conducted over 2 and a half months The control group received no SMS reminder message. The first intervention group (SMS1) received a simple SMS reminder to return to the clinic to collect their TB test results. Clinic staff told patients to return in two (working) days’ time to get their results, and the SMS was sent via a bulk SMS service around 6-7pm the evening before. The message in English read “Don't forget to collect your results from the clinic tomorrow.” The second intervention group (SMS2) received a longer SMS message reminding them to return to the clinic, and that people die unnecessarily from TB because it can be cured. The message in English read: “Don't forget to collect your results from the clinic tomorrow. 96,000 South Africans die every year from TB. This should not be – TB can be cured”. Both messages were translated into and sent in Xhosa for those who had said in their baseline interview that this was their native language. The records of the bulk SMS service were checked to make sure that the SMS messages were delivered to the patient’s mobile phone, that the correct SMS was sent, and that patients in the control group did not inadvertently receive a message. 254
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult, provided consent, not already on treatment, waiting for a TB test or just had a TB test Adult, refused consent, already on treatment, not waiting for a TB test or just had a TB test 80 and over: 80+ Year,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) 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 08/11/2016 Research Ethics Committee Humanities
Ethics Committee Address
Street address City Postal code Country
Wilcocks building, 52 Ryneveld street Stellenbosch 7600 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Our primary outcomes capture what percentage of the full sample return for their test results and how quickly. We report the percentage of recruits returning at all, the median days to return, and the percentages returning within 2, 5, 10 and 20 business days.
Secondary Outcome Our primary outcomes capture what percentage of the sample that received the intervention-as-stipulated return for their test results and how quickly. We report the percentage of recruits returning at all, the median days to return, and the percentages returning within 2, 5, 10 and 20 business days.
Secondary Outcome Our primary outcomes capture what percentage of the HIV positive subsample return for their test results and how quickly. We report the percentage of recruits returning at all, the median days to return, and the percentages returning within 2, 5, 10 and 20 business days.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mzamomhle Salwityi Road, Browns Farm, Phillipi Cape Town South Africa
Nolungile clinic Solomon Tshuku Road, Site C, Khayelitsha Cape Town South Africa
Gugulethu clinic Corner of NY1 and NY3, Gugulethu Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
World Bank Research Support Budget 1818 H Street NW Washington DC 20433 United States of America
The South Africa Development Fund 555 Amory St Jamaica Plain MA 02130 United States of America
The Abdul Latif Jameel Poverty Action Lab 400 Main St Suite 201 Cambridge MA 02142 United States of America
WHO Strengthening Implementation grant Avenue Appia 20 Geneva Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stellenbosch University Economics Department Bosman Street Stellenbosch 7600 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Eddy van Doorslaer Erasmus University Rotterdam Netherlands
Adam Wagstaff World Bank Washington DC United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ronelle Burger rburger@sun.ac.za +27838863016 Office 613A, Schumann building, Stellenbosch University, Bosman street
City Postal code Country Position/Affiliation
Stellenbosch 7600 South Africa Professor Stellenbosch University
Role Name Email Phone Street address
Public Enquiries Ronelle Burger rburger@sun.ac.za +27838863016 Office 613a, Schumann building, University of Stellenbosch, Bosman street
City Postal code Country Position/Affiliation
Stellenbosch 7600 South Africa Professor
Role Name Email Phone Street address
Scientific Enquiries Adam Wagstaff awagstaff@worldbank.org +12024730566 The World Bank, 1818 H St NW
City Postal code Country Position/Affiliation
Washington DC 20433 United States of America Research Manager in the Development Research Group
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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