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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.
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