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: pactr.samrc.ac.za
Trial no.: PACTR201904582515723 Date of Approval: 26/04/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The HIV/AIDS mobile phone and home visit trial
Official scientific title Retention and adherence among adolescents living with HIV: an overview of the Centre region of Cameroon
Brief summary describing the background and objectives of the trial Adherence to medication and retention in care has become a primary focus of research in adolescents living with HIV. Implement and evaluate a range of effective adherence and retention management interventions is imperative in Cameroon. Mobile Health using mobile Phone technology and peer educator concept has demonstrated promising results in patient care. The Short Message Service of Mobile Phones can be used as a reminder to improve adherence to ART. We are testing the effectiveness of daily and twice monthly home visit by peer educator test.
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
Purpose of the trial Education /Training
Anticipated trial start date 01/07/2018
Actual trial start date 01/07/2018
Anticipated date of last follow up 01/02/2019
Actual Last follow-up date 01/02/2019
Anticipated target sample size (number of participants) 184
Actual target sample size (number of participants) 152
Recruitment status Closed to recruitment,follow-up continuing
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 Simple randomization using a randomization table created by a computer software program 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 Daily Mobile Phone SMS Reminder One daily 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. 46
Experimental Group Home visit by peer educator One home visit per month 6 months Adolescents who live with HIV and who have a suppression viral load will do home visit to those adolescents in this others group 46
Control Group Standart care 6 months usual care 46 Uncontrolled
Control Group standard care 6 months Usual care 46 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescents living with HIV (10-19 ans) On ART treatment for at least 6 months, With VL test availaible, Owns or have access a mobile phone and can read (caregivers) text messages parent consent Has not been on antiretroviral therapy for up to six months Does not have access to mobile phone Does not provide consent or assent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 10 Year(s) 19 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
Yes 01/03/2018 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 00237 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 01/03/2018 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 00237 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 01/03/2018 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 00237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence rate, retention rate 3 months
Secondary Outcome adherence rate, retention rate and viral load count, change of treatment regimen 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fondation Chantal Biya Health facility Tel 222222000 Yaound Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Sel Funded Central town YAOUNDE Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KETCHAJI ALICE Faculty of Health Sciences, University of Buea, P.O Box 12 BUEA 00237 Cameroon University
COLLABORATORS
Name Street address City Postal code Country
3Ngowe Ngowe Marcelin Faculty of Health Sciences, University of Buea, P.O Box 12 BUEA 00237 Cameroon
Monebenimp Francisca Faculty of Medicine and Biomedical Sciences Yaounde 00237 Cameroon
Felix Assah Department of Public Health, Faculty of Medicine and Biomedical Sciences, Yaound 00237 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator KETCHAJI ALICE ketchajialice2015@gmail.com 00237677034635 Buea
City Postal code Country Position/Affiliation
Yaound 00237 Cameroon Cadre at the Ministry of Public health Cameroon
Role Name Email Phone Street address
Scientific Enquiries Ngowe Ngowe Marcelin nkouki2002@yahoo.fr 00237677216858 BUEA
City Postal code Country Position/Affiliation
BUEA 00237 Cameroon Dean of the faculty of health sciences
Role Name Email Phone Street address
Scientific Enquiries Monebenimp Francisca Francisca fmonebe@yahoo.fr 677742747 Yaound
City Postal code Country Position/Affiliation
Yaound 00237 Cameroon Head of department of Public health faculty of Medecine and biomediacal science University of Yaound 1
Role Name Email Phone Street address
Scientific Enquiries ASSAH Felix kembeassah@yahoo.com 00237674486342 Yaounde
City Postal code Country Position/Affiliation
Yaound 00237 Cameroon Lecturer
Role Name Email Phone Street address
Public Enquiries KETCHAJI ALICE ketchajialice2015@gmail.com 00237677034635 Yaounde
City Postal code Country Position/Affiliation
Yaound 00237 Cameroon PhD student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Patient Data will be analysed and the result will be reconstituted to the community. Results will be disseminated in Peer Review Journals at Midterm and at the end of intervention Informed Consent Form,Study Protocol At the mid-term of intervention and 2 months after end line The Data shall be openly available
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not applicable No
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