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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.: PACTR201011000261458 Date registered: 2010/11/11
TRIAL DESCRIPTION
Public title The Cameroon Mobile Phone SMS Trial
Official scientific title The Cameroon Mobile Phone SMS Trial
Brief summary describing the background
and objectives of the trial
Mobile phone technology is an uprising domain in patient care. The Short Message Service can be used as a reminder to improve adherence to care. In this study we are testing the efficacy of weekly mobile text messages to improve adherence to ARV medication.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Treatment
Anticipated trial start date 2010-11-22
Actual trial start date
Anticipated date of last follow up 2011-06-20
Actual date of last follow up
Anticipated target sample size (number of participants) 198   
Actual target sample size (number of participants)   
Recruitment status Closed to recruitment: follow up continuing
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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 A computer generated randomization list using random block sizes of 2,4 and 6 The allocation codes were placed in sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group SMS+ Daily Six months We will send a short text message to the participants in the intervention group in both French and English. The content of the message will be motivating and will act both as a reminder and a cue to action. 99
Control group Usual care Six months Routine adherence counselling and rare home visits 99

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Age above 21 years Owns a mobile phone Can read text messages Has been on ARV for at least a month Gives informed consent orally and in writing. Aged less than 21 years Doesn't own a mobile phone Hasn't been on ARV for up to a month Doesn't provide content 21 Years 65 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 2010/10/20 Cameroon National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Nkoleton Yaoundé PO BOX 1937 Cameroon

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence Three months Six months
Primary Outcome Adherence Three months Six months
Secondary Outcome Weight Three months Six months
Secondary Outcome Body Mass Index Three months Six months
Secondary Outcome Opportunistic infections Three months Six months
Secondary Outcome WHO Classification Three months Six months
Secondary Outcome CDC Classification Three months Six months
Secondary Outcome Mortality Three months Six months
Secondary Outcome CD4 count 6 months
Secondary Outcome Viral Load Six months
Secondary Outcome Quality of life Three months Six months
Secondary Outcome Weight Three months Six months
Secondary Outcome Body Mass Index Three months Six months
Secondary Outcome Opportunistic infections Three months Six months
Secondary Outcome WHO Classification Three months Six months
Secondary Outcome CDC Classification Three months Six months
Secondary Outcome CD4 count 6 months
Secondary Outcome Viral Load Six months
Secondary Outcome Quality of life Three months Six months

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Yaoundé Central Hospital Accredited HIV Treatment Centre Avenue Henri Dunant, Messa Yaoundé PO Box 87 Cameroon

FUNDING SOURCES
Name of source Street address City Postal code Country
CIHR CTN Post-Doctoral Fellowship award Canada
Centre for the Development of Best Practices in Health Avenue Henri Dunant, Messa Yaoundé PO Box 87 Cameroon
CIHR CTN Post-Doctoral Fellowship award Canada
Centre for the Development of Best Practices in Health Avenue Henri Dunant, Messa Yaoundé PO Box 87 Cameroon

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CIHR CTN Post-Doctoral Fellowship award Canada Funding Agency
Primary Sponsor CIHR CTN Post-Doctoral Fellowship award Canada Funding Agency

COLLABORATORS
Name Street address City Postal code Country
Lehana Thabane 50 Charlton Avenue East Hamilton ON L8N 4A6 Canada
Jimmy Volmink Tygerberg, 7505 Capetown PO Box 19063 South Africa
Lehana Thabane 50 Charlton Avenue East Hamilton ON L8N 4A6 Canada
Jimmy Volmink Tygerberg, 7505 Capetown PO Box 19063 South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Lawrence Mbuagbaw mbuagbawl@yahoo.com +237 75552864
Street address City Postal code Country Position / Affiliation
Rue Essomba, Immeuble Onyebuchi Yaoundé Cameroon CIHR CTN Post-Doctoral Fellow
Role Name Email Phone Fax
Scientific Enquiries Dr Lawrence Mbuagbaw mbuagbawl@yahoo.com +237 75552864
Street address City Postal code Country Position / Affiliation
Rue Essomba, Immeuble Onyebuchi Yaoundé Cameroon CIHR CTN Post-Doctoral Fellow
Role Name Email Phone Fax
Public Enquiries Dr Charles Kouanfack charleskouanfack@yahoo.fr +23799950743
Street address City Postal code Country Position / Affiliation
Yaoundé Cameroon Study site Coordinator