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. 101 Control group Usual care Six months Routine adherence counselling and rare home visits 99 Control group Control Usual care Six months Usual care 99 Placebo 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