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.: PACTR201802003035922 Date of Approval: 01/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The HIV/TB Co-infection Mobile Phone SMS Trial
Official scientific title Rentention in Care and Adherence to Treatment in HIV/TB Co-Infection
Brief summary describing the background and objectives of the trial Mobile Health using mobile Phone technology has demonstrated promising results in patient care. The Short Message Service of Mobile Phones can be used as a reminder to improve retention in care and promote adherence to treatment. We are testing the effectiveness of once weekly and twice weekly mobile phone test messages to improve retention in care and promote adherence to treatment among HIV and Tuberculosis co-infected patients.
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 HIV/AIDS,Tuberculosis
Purpose of the trial Education /Training
Anticipated trial start date 08/05/2018
Actual trial start date
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 228
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 block size of 4 The allocation codes were placed in sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Once Weekly Mobile Phone SMS Reminder Once weekly 6 months We shall send short text messages to the participants in the intervention group in either English or French Language. The content of the messages shall be motivational and shall serve both as reminders and clue to actions. 76
Experimental Group Twice Weekly Mobile Phone SMS Reminder Twice weekly 6 months We shall send short text messages to the participants in the intervention group in either English or French Language. The content of the messages shall be motivational and shall serve both as reminders and clue to actions 76
Control Group Standard care Usual care 6 months Routine adherence counselling and rare home visits 76
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged 21 years and above Owns or have access to a mobile phone Can read Text messages Has been on antiretroviral therapy for at least one month Gives Informed consent or Assent orally and in writing Aged less than 21 years Does not have access to mobile phone Has not been on antiretroviral therapy for up to one month Does not provide consent or assent 21 Year(s) 65 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
No Faculty of Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, University of Buea, P.O Box 12 Buea +237 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 07/03/2018 Faculty of Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, University of Buea, P.O Box 12 Buea +237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Retention in care Baseline Two months Four months Six months
Primary Outcome Adherence Baseline Two months Four months Six months
Primary Outcome Virologic suppression Baseline Six months
Secondary Outcome Weight Baseline Two months Four months Six months
Secondary Outcome Body Mass Index Baseline Two months Four months Six months
Secondary Outcome Blood Pressure Baseline Two months Four months Six months
Secondary Outcome Opportunistic infections Baseline Two months Four months Six months
Secondary Outcome Quality of Life Baseline Two months Four months Six months
Secondary Outcome CD4 T cell count Baseline Six months
Secondary Outcome Waist Hip Ratio Baseline Two months Four months Six months
Secondary Outcome Tuberculosis co-infection Baseline Two months Four months Six months
Secondary Outcome WHO classification Baseline Two months Four months Six months
Secondary Outcome CDC classification Baseline Two months Four months Six months
Secondary Outcome Satisfaction with care Baseline Six months
Secondary Outcome Mortality Baseline Six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tiko Cottage Hospital HIV Treatment Centre Tiko Tiko Cameroon
Limbe Regional Hospital HIV Treatment Centre Mile 1 Limbe Cameroon
Buea Regional Hospital HIV Treatment Centre Clark's quarter Buea Cameroon
Muyuka District Hospital HIV Treatment Centre Buea-Kumba Road Muyuka Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanue Elvis Asangbeng Faculty of Health Sciences, University of Buea, P.O Box 12 Buea +237 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanue Elvis Asangbeng Faculty of Health Sciences, University of Buea, P.O Box 12 Buea +237 Cameroon University
COLLABORATORS
Name Street address City Postal code Country
Professor Nsagha Dickson Shey Faculty of Health Sciences, University of Buea, P.O Box 12 Buea +237 Cameroon
Professor Assob Nguedia Jules Clement Faculty of Health Sciences, University of Buea, P.O Box 12 Buea +237 Cameroon
Dr. Nana Djamen Theophile Faculty of Health Sciences, University of Buea, P.O Box 12 Buea +237 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elvis Asangbeng Tanue asangbengelvis@gmail.com +237676558906 Faculty of Health Sciences, University of Buea, P.O Box 12
City Postal code Country Position/Affiliation
Buea +237 Cameroon Lectuerer, PhD candidate/Faculty of Health Sciences, University of Buea
Role Name Email Phone Street address
Public Enquiries Elvis Asangbeng Tanue asangbengelvis@gmail.com +237676558906 Faculty of Health Sciences, University of Buea, P.O Box 12
City Postal code Country Position/Affiliation
Buea +237 Cameroon Lectuerer, PhD candidate/Faculty of Health Sciences, University of Buea
Role Name Email Phone Street address
Scientific Enquiries Dickson Shey Nsagha nsaghads@hotmail.com +23767799429 Faculty of Health Sciences, University of Buea, P.O Box 12
City Postal code Country Position/Affiliation
Buea +237 Cameroon Vice Dean-SSA, Associate Professor of Epidemiology/Faculty of Health Sciences, University of Buea
Role Name Email Phone Street address
Scientific Enquiries Dickson Shey Nsagha nsaghads@hotmail.com +23767799429 Faculty of Health Sciences, University of Buea, P.O Box 12
City Postal code Country Position/Affiliation
Buea +237 Cameroon Vice Dean-PAA, Associate Professor of Epidemiology/Faculty of Health Sciences, University of Buea
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 30/04/2018 Recent development and modification due to administrative procedures 2018-03-01 2018-05-08
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 14/02/2018 New information 2018-09-28
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 14/02/2018 First date was mistakenly chosen 2018-02-19 2018-03-01
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 30/04/2018 Recent development and modification due to administrative procedures 2018-09-28 2018-10-31
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 30/04/2018 administrative reasons Aged 15 years and above Owns or have access to a mobile phone Can read Text messages Has been on antiretroviral therapy for at least one month Gives Informed consent or Assent orally and in writing Aged 21 years and above Owns or have access to a mobile phone Can read Text messages Has been on antiretroviral therapy for at least one month Gives Informed consent or Assent orally and in writing
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 30/04/2018 administrative reasons Aged less than 15 years Does not have access to mobile phone Has not been on antiretroviral therapy for up to one month Does not provide consent or assent Aged less than 21 years Does not have access to mobile phone Has not been on antiretroviral therapy for up to one month Does not provide consent or assent
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 30/04/2018 administrative reasons 21 21
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 05/07/2018 pactr update Treatment: Other Education /Training