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.: PACTR201307000583416 Date of Approval: 05/07/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Supportive care
Anticipated trial start date 30/08/2012
Actual trial start date 21/02/2013
Anticipated date of last follow up 30/06/2013
Actual Last follow-up date 25/02/2014
Anticipated target sample size (number of participants) 260
Actual target sample size (number of participants) 260
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Care giver/Provider
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 Age Category Minimum age Maximum 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 Year(s) 60 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 02/05/2012 National Ethics Committee of Cameroon
Ethics Committee Address
Street address City Postal code Country
Yaoundé BP:1937 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 04/12/2012 Administrative Authorization of Research (Ministry of Public Health of Cameroon)
Ethics Committee Address
Street address City Postal code Country
Yaoundé 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
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
Centre de Santé Catholique de Mvolyé 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
Georges BEDIANG Faculty of Medicine and Biomedical Sciences Yaoundé 1364 Cameroon
Beat STOLL Chemin de la Tour de Champel 17 Geneva 1206 Switzerland
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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Georges Bediang bediang@yahoo.com + 237 99 58 85 74 Faculty of Medicine and Biomedical Sciences
City Postal code Country Position/Affiliation
Yaoundé Cameroon Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Cameroon
Role Name Email Phone Street address
Public Enquiries Jean-Louis Abena jlabena@yahoo.com +237 99 96 16 34 Street of Jamot Hospital
City Postal code Country Position/Affiliation
Yaoundé Cameroon National Tuberculosis Control Programme, Ministry of Public Health, Cameroon
Role Name Email Phone Street address
Scientific Enquiries Beat Stoll beat.stoll@unige.ch +41 79 378 96 05 Chemin de la Tour de Champel 17
City Postal code Country Position/Affiliation
Geneva 1206 Switzerland Institute of Social and Preventive Medicine, Faculty of Medicine, University of Geneva, Switzerland
Role Name Email Phone Street address
Scientific Enquiries Antoine Geissbuhler antoine.geissbuhler@hcuge.ch +41 79 373 23 82 Rue Gabrielle-Perret-Gentil 4
City Postal code Country Position/Affiliation
Geneva 1211 Switzerland Department of Radiology and Medical Informatics, University of Geneva, Switzerland
REPORTING
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