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.: PACTR201310000671259 Date of Approval: 07/10/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Use of SMS services to improve Tuberculosis treatment completion
Official scientific title Use of SMS services to improve Tuberculosis treatment completion
Brief summary describing the background and objectives of the trial Patients in sub-Saharan Africa have the highest rates of defaulting treatment of tuberculosis (TB). Mobile technology-based interventions have been shown to improve adherence to antiretroviral treatment (ART) in Kenya, and could therefore be an inexpensive and effective tool to increase TB treatment completion. This study aims to test the impact of a Short Message Service (SMS) intervention on TB default rates in an integrated TB-HIV clinic in Kampala, Uganda and to assess patient satisfaction.
Type of trial CCT
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 HIV/AIDS,Tuberculosis
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/10/2010
Actual trial start date 01/11/2010
Anticipated date of last follow up 01/12/2011
Actual Last follow-up date 21/12/2011
Anticipated target sample size (number of participants) 582
Actual target sample size (number of participants) 485
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
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SMS awareness and reminder service 2-3x/week (depending on stage of treatment) 8 weeks There are three different types of SMS text messages: adherence reminders (on days 2, 7 and 11 after the most recent appointment), reminders of upcoming appointments (1 per 2 weeks, sent the day before the appointment) and educational quizzes (on days 3, 6, 9 and 12 after the most recent appointment). 183
Control Group none 302 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age ¿ 18 years Informed consent Newly diagnosed active tuberculosis, as defined by the current WHO guidelines (26), for which TB treatment will be initiated or has been initiated in the two weeks prior to the screening for eligibility Ownership of or sufficient access to a mobile phone (shared access will be allowed if access is daily, patients have disclosed or are willing to disclose their TB status to the phone owner and/or any other users of the phone, and the phone owner agrees to participate) Demonstrated ability to sufficiently operate a cell phone to communicate using textmessaging, assessed by typing and sending a sample text message at enrolment Literacy (for illiterate patients who have disclosed or are willing to disclose their TB status help by a treatment buddy will be sufficient) Willingness and ability to comply with study procedures. Any specific condition that in the judgment of the investigator precludes participation because it could affect a participant¿s safety. For the historical control group: no mobile phone number recorded at treatment initiation 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 24/08/2010 Makerere University School of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mulago Hospital Complex Kampala 7072 Uganda
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 21/10/2010 Johns Hopkins University School of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
1620 McElderry Street, Reed Hall, Suite B-130 Baltimore, Maryland 21205-1911 United States of America
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 09/09/2010 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road, Ntinda Kampala 6884 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome TB treatment default at 8 weeks at 8 months
Secondary Outcome Proportion of patients who undergo a repeat sputum at 8 weeks
Secondary Outcome TB drug adherence (expressed in percentages of pills taken) per visit
Secondary Outcome ART adherence (expressed in percentages of pills taken) per HIV visit
Secondary Outcome Clinic attendance, expressed as number of missed at 8 weeks
Secondary Outcome Patients¿ satisfaction and knowledge on TB/HIV issues at 8 weeks
Secondary Outcome Cost-effectiveness at 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Integrated TB/HIV clinic, Infectious Diseases Institute, Makerere University College of Health Sciences Mulago Hospital Complex Kampala 22418 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Microsoft Research Limited Robert Needham Building, 7JJ Thomson Avenue Cambridge CB3 0FB United Kingdom
KNCV Tuberculosis Foundation Parkstraat 17 Den Haag 2514 JD Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Yukari Manabe Mulago Hospital Complex Kampala 22418 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Text to Change (Bas Hoefman) Katali Rise, Plot nr. 4a Naguru Kampala 40187 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sabine Hermans s.hermans@aighd.org +27726940945 Trinity Building C, Pietersbergweg 17
City Postal code Country Position/Affiliation
Amsterdam Zuidoost 1105BM Netherlands Post-doctoral researcher
Role Name Email Phone Street address
Public Enquiries Sabine Hermans s.hermans@aighd.org +27726940945 AIGHD, Trinity Building C, Pietersbergweg 17
City Postal code Country Position/Affiliation
Amsterdam Zuidoost 1105 BM Netherlands post-doctoral researcher
Role Name Email Phone Street address
Scientific Enquiries Sabine Hermans s.hermans@aighd.org +27726930945 AIGHD, Trinity Buildings C, Pietersbergweg 17
City Postal code Country Position/Affiliation
Amsterdam Zuidoost 1105BM Netherlands post-doctoral researcher
REPORTING
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