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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.: PACTR201307000583416 Date registered: 2013/07/05
TRIAL DESCRIPTION
Public title TB-SMS Cameroon
Official scientific title Evaluation of therapeutic adherence support by SMS on the cure rate of Tuberculosis: a protocol of a randomized control study
Brief summary describing the background
and objectives of the trial
The objective of this study is to evaluate the effect of SMS reminders on the cure rate of positive pulmonary tuberculosis patient in order improve its nn Cameroon. Now, the Cameroon National Tuberculosis Control Programme reported that the cure rate for patients with sputum positive pulmonary tuberculosis (TPM+) after 6 months was 65% in 2010, 20% below the target.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Tuberculosis ,
Purpose of the trial Supportive care
Anticipated trial start date 2012-08-30
Actual trial start date 2013-02-21
Anticipated date of last follow up 2013-06-30
Actual date of last follow up 2014-02-25
Anticipated target sample size (number of participants) 260   
Actual target sample size (number of participants) 260   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
N°072/CNE/SE/2012 National Ethics Committee of Cameroon
Administrative authorization Research: N°631-17/12 Minitry of Public Health (Cameroon)

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 Simple randomisation using a radomisation table created by a computer software program Once a participant is recruited, his code and telephone number will be communicated to the secretary who will then put him in one of the groups. Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group SMS reminders 1 SMS per day 6 months DOST Strategy + Welcome SMS +1 SMS per day 130
Control group No SMS 0 SMS 6 months DOST Strategy + Welcome SMS 130

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
- must be new smear positive pulmonary tuberculosis - to have at least 18 years (born before 1st January 1995). - the patient must know how to read French or English - have a mobile phone number for personal use - know how to open and read an SMS on his telephone - give his consent (signed on the informed consent form) - to be an hospitalised or severely ill patient as identified by health staff 18 Years 60 Years 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 2012/12/04 Administrative Authorization of Research (Ministry of Public Health of Cameroon)
Ethics Committee Address
Street address City Postal code Country
Yaoundé Cameroon
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 2012/05/02 National Ethics Committee of Cameroon
Ethics Committee Address
Street address City Postal code Country
Yaoundé BP:1937 Cameroon

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The cure rate at 6 months in the groups « SMS intervention » and « Control ». - at 6 month
Secondary Outcome The rate of treatment adherence (regularity in the respect of prescriptions and the percentage of prescribed doses taken) - at 2 month - at 5 month - at 6 month
Secondary Outcome Treatment failure - at 5 month
Secondary Outcome The degree of satisfaction at 6 month

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Santé Catholique de Mvolyé Yaoundé Cameroon
Hôpital Jamot Yaoundé Cameroon
Centre de Santé Catholique de Mimboman Yaoundé Cameroon
Centre de Santé Catholique de Nkoldongo Yaoundé Cameroon
Centre de Santé Catholique de la Briqueterie Yaoundé Cameroon
Centre de Santé Catholique d'Etoug-Ebe Yaoundé Cameroon
Centre de Santé Baptiste d'Etoug-Ebe Yaoundé Cameroon
Hôpital Militaire de Yaoundé Yaoundé Cameroon
Hôpital de la Cité Verte Yaoundé Cameroon
Hôpital de la CNPS Yaoundé Cameroon
Centre Médical d'Olembe Yaoundé Cameroon
Hôpital EPC de Djoungolo Yaoundé Cameroon
Hôpital Central de Yaoundé Yaoundé Cameroon
Hôpital de District de Biyem-Assi Yaoundé Cameroon
Hôpital Général de Yaoundé Yaoundé Cameroon
Centre de Santé de Mvog-Beti Yaoundé Cameroon

FUNDING SOURCES
Name of source Street address City Postal code Country
Réseau en Afrique Francophone pour la Télémédecine (Geneva University Hospital) Rue gabrielle-perret-gentil 4 Geneva 1211 Switzerland

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Réseau en Afrique Francophone pour la Télémédecine (Geneva University Hospital) Rue gabrielle-perret-gentil 4 Geneva 1211 Switzerland Hospital

COLLABORATORS
Name Street address City Postal code Country
Nadia ELIA Chemin de la Tour de Champel 17 Geneva 1206 Switzerland
Jean-Louis ABENA Street of Jamot Hospital of Yaounde Yaoundé Cameroon
Désiré NOLNA Street of Jamot Hospital of Yaounde Yaoundé Cameroon
Philippe CHASTONAY Chemin de la Tour de Champel 17 Geneva 1206 Switzerland
Antoine GEISSBUHLER Rue gabrielle-perret-gentil 4 Geneva 1211 Switzerland
Georges BEDIANG Faculty of Medicine and Biomedical Sciences Yaoundé 1364 Cameroon
Beat STOLL Chemin de la Tour de Champel 17 Geneva 1206 Switzerland

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Georges Bediang bediang@yahoo.com + 237 99 58 85 74
Street address City Postal code Country Position / Affiliation
Faculty of Medicine and Biomedical Sciences Yaoundé Cameroon Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Cameroon
Role Name Email Phone Fax
Public Enquiries Dr Jean-Louis Abena jlabena@yahoo.com +237 99 96 16 34
Street address City Postal code Country Position / Affiliation
Street of Jamot Hospital Yaoundé Cameroon National Tuberculosis Control Programme, Ministry of Public Health, Cameroon
Role Name Email Phone Fax
Scientific Enquiries Dr Beat Stoll beat.stoll@unige.ch +41 79 378 96 05
Street address City Postal code Country Position / Affiliation
Chemin de la Tour de Champel 17 Geneva 1206 Switzerland Institute of Social and Preventive Medicine, Faculty of Medicine, University of Geneva, Switzerland
Role Name Email Phone Fax
Scientific Enquiries Prof Antoine Geissbuhler antoine.geissbuhler@ hcuge.ch +41 79 373 23 82
Street address City Postal code Country Position / Affiliation
Rue Gabrielle-Perret-Gentil 4 Geneva 1211 Switzerland Department of Radiology and Medical Informatics, University of Geneva, Switzerland