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.: PACTR201311000695277 Date of Approval: 04/11/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Smoking cessation trial in patients with tuberculosis
Official scientific title The efficacy of brief motivational interviewing on smoking cessation at tuberculosis clinics in Tshwane, South Africa: a randomised controlled trial.
Brief summary describing the background and objectives of the trial TB patients who smoke have a higher risk for adverse TB outcomes and a range of other diseases caused by smoking.This study aims to determine whether brief motivational interviewing by lay counsellors is more effective than brief advice by the TB professional nurse, in increasing the proportion of respondents with prolonged tobacco abstinence at 6 months (primary outcome) and at 3 months and in increasing point prevalence abstinence rates and quit attempts (secondary outcomes).
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,tobacco smoking
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Education /Training
Anticipated trial start date 12/09/2011
Actual trial start date 14/09/2011
Anticipated date of last follow up 30/10/2012
Actual Last follow-up date 25/04/2013
Anticipated target sample size (number of participants) 560
Actual target sample size (number of participants) 409
Recruitment status Completed
Publication URL ¿ Louwagie GMC, Ayo-Yusuf O. Predictors of tobacco smoking abstinence among Tuberculosis patients in South Africa. J Behav Medicine 2015; 38(2):472-482. doi: 10.1007/s10865-015-9620-y.
Secondary Ids Issuing authority/Trial register
116/2011 Faculty of Health Sciences Research Ethics Committee, University of Pretoria
DOH-27-0811-3539 (SA DOH Trial Number) Department of Health South Africa
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 randomisaton with block sizes of 2,4,6,8 and 10 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Brief Motivational interviewing Once off 15-20 Minutes Brief Motivational Interviewing Counselling session delivered by lay Health Care Worker 205
Control Group Brief advice Once off One minute Brief cessation advice 204 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult Starting TB treatment or on TB treatment for less than or equal to one month Able to understand English or the most commonly spoken local language (Sepedi/Setswana) Too ill to participate Under 18 years On TB treatment for more than 1 month Unable to understand English or the most commonly locally spoken language Too ill to participate 18 Year(s) 105 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 27/07/2011 Faculty of Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
HW Snyman Building South Level 2-34, Faculty of Health Sciences, UP, Bophelo road, Gezina, Pretoria Pretoria 0007 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Prolonged smoking abstinence 6 month follow-up
Secondary Outcome 3 month prolonged abstinence 3 month
Secondary Outcome 7 day point prevalence abstinence 1 month 3 month 6 month
Secondary Outcome Quit attempt 1 month 3 month 6 month
Secondary Outcome Treatment fidelity 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kgabo Mabopane subdistrict, Mabopane City of Tshwane Metropolitan City 0190 South Africa
Soshanguve 3 clinic Block Bb, 1834 Soshanguve Street City of Tshwane Metropolitan City 0152 South Africa
Block X clinic Block X, Soshanguve City of Tshwane Metropolitan City 0164 South Africa
JJ clinic Block JJ, Soshanguve City of Tshwane Metropolitan City 0164 South Africa
TT clinic Block TT, Soshanguve City of Tshwane Metropolitan City 0164 South Africa
KT Motubatse CHC 20941 Ext 4, Soshanguve City of Tshwane Metropolitan City 0152 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
KNCV Tuberculosis Foundation Parkstraat 17, PO Box 146 Den Hague 2501 Netherlands
Global Bridges Health Care Alliance for Tobacco Dependence Mayo Clinic 200 First St. SW, Rochester 55905 United States of America
National Research Foundation Meiring Naudé Road Brummeria Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KNCV Tuberculosis Foundation Parkstraat 17, PO Box 146 Den Hague 2501 Netherlands Charities/Societies/Foundation
Secondary Sponsor Global Bridges Health Care Alliance for Tobacco Dependence Mayo clinic, 200 First Street Rochester MN 55905 United States of America Charities/Societies/Foundation
Secondary Sponsor National Research Foundation Meiring Naude Road Brummeria Pretoria 0001 South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Goedele Louwagie HW Snyman Building North 5-28, Bophelo Road, Gezina Pretoria 0031 South Africa
Olalekan Ayo-Yusuf 6th floor, Hospitaal for Tand-en Mondheelkunde, Dr Savage road, Gezina Pretoria 0031 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator goedele Louwagie goedele.louwagie@up.ac.za 0027123541478 HY Snyman Building-N 5-28, Faculty of Health Sciences, Bophelo road, Gezina
City Postal code Country Position/Affiliation
Pretoria 0031 South Africa Senior lecturer
Role Name Email Phone Street address
Public Enquiries goedele Louwagie goedele.louwagie@up.ac.za 0027123541478 HY Snyman Building-N 5-28, Faculty of Health Sciences, Bophelo road, Gezina
City Postal code Country Position/Affiliation
Pretoria 0031 South Africa Senior lecturer
Role Name Email Phone Street address
Scientific Enquiries goedele Louwagie goedele.louwagie@up.ac.za 0027123541478 HY Snyman Building-N 5-28, Faculty of Health Sciences, Bophelo road, Gezina
City Postal code Country Position/Affiliation
Pretoria 0031 South Africa Senior lecturer
REPORTING
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