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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.: PACTR201304000528276 Date registered: 2013/04/07
TRIAL DESCRIPTION
Public title A randomized blinded controlled trial of mobile phone reminders on the follow-up medical care of HIV-exposed and HIV-infected children in Cameroon
Official scientific title MORE CARE: A randomized blinded controlled trial of mobile phone reminders on the follow-up medical care of HIV-exposed and HIV-infected children in Cameroon
Brief summary describing the background
and objectives of the trial
In Cameroon, only two third of HIV-infected or ¿exposed children are received at appointment. It is known that mortality, ART resistance and virological response are strongly related to miss appointment. This trial aimed at determining which of phone calls, text message (SMS) and concomitant SMS and phone calls is the best method to increase the presence at medical appointments of HIV -infected or -exposed children, and which is the most efficient related to time working time and financial cost
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 Prevention
Anticipated trial start date 2013-02-04
Actual trial start date 2013-02-04
Anticipated date of last follow up 2013-04-15
Actual date of last follow up 2013-05-31
Anticipated target sample size (number of participants) 224   
Actual target sample size (number of participants) 242   
Recruitment status Completed: recruitment & data analysis complete
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
Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously Randomised Permuted block randomisation with Winepi sofware. block size 4 Sequential allocation Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group SMS and Calls Once before the appointment Two days We will send a text message 3 days before the appointment. The message will help remind the patient to the appointment. Then, the call will be issued two days before the appointment to remind the person accompanying the child to bring him to the hospital. 56
Experimental group SMS Once before the appointment One day We will send a text message 2 days before the appointment. The message will help remind the patient to the appointment. 56
Experimental group Calls Once before the appointment One day The phone calls will be emited 48 hours before the appointment, between 10 am and 12 am. 56
Control group Control Usual give of appointment 56

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Subjects accompanying a child aged under 15 years infected or exposed to HIV We will include in the study all persons aged 18 years or older accompanying a HIV- infected or exposed child aged less than15 years for HIV care and consenting to participate in the study. 18 Years 100 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 2013/01/28 NATIONAL RESEARCH ETHICS COMMITTEE FOR HUMAN HEALTH
Ethics Committee Address
Street address City Postal code Country
Hygiène mobile Yaoundé 1937 Cameroon

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome efficiency of intervention A day of appointment
Primary Outcome Efficacy of interventions A day of appointment
Secondary Outcome Successful of interventions A day of intervention

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Accredited Centre of HIV Treatment of Kousséri Regional Hospital Kousséri Downtown Kousséri 272 Cameroon
Accredited Centre of HIV Treatment (ACT) of Essos Hospital Essos Yaoundé 441 Cameroon
Taking Charge Unit of HIV of Goulfey District Hospital Goulfey Downtown Goulfey 62 Cameroon

FUNDING SOURCES
Name of source Street address City Postal code Country
Bigna Rim Jean Joel Melen Yaoundé 1364 Cameroon

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1 Melen Yaoundé 1364 Cameroon University
Primary Sponsor Faculty of medicine, University of Montpellier 1 UFR Médecine 2 rue Ecole de Médecine CS 59001 Montpellier 34060 France University

COLLABORATORS
Name Street address City Postal code Country
Kouanfack Charles Melen Yaoundé 1364 Cameroon
Koulla Sinata Shiro Melen Yaoundé 1364 Cameroon
Jean Jacques N. Noubiap Edéa Downtown Edéa 100 Cameroon
Claudia S. Plottel New York United States of America

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Jean Joel Bigna Rim bignarimjj@yahoo.fr +23797224938 +23722212510
Street address City Postal code Country Position / Affiliation
Melen Yaoundé 1364 Cameroon student
Role Name Email Phone Fax
Public Enquiries Dr Jean Joel Bigna Rim bignarimjj@yahoo.fr +23797224938 +23722212510
Street address City Postal code Country Position / Affiliation
Melen Yaoundé 1364 Cameroon student
Role Name Email Phone Fax
Scientific Enquiries Dr Jean Joel Bigna Rim bignarimjj@yahoo.fr +23797224938 +23722212510
Street address City Postal code Country Position / Affiliation
Melen Yaoundé 1364 Cameroon student