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.: 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
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/12/2018 It was just an error Control Group, Standart care, , 6 months, usual care, 46, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 24/01/2019 It was an error Adolescents HIV: SMS and peer educator trial Retention and adherence among adolescents living with HIV: an overview of the Centre region of Cameroon
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 24/01/2019 It was an error Retention in care and adherence among adolescents living with HIV in the Centre region, Cameroon Retention and adherence among adolescents living with HIV: an overview of the Centre region of Cameroon
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/01/2019 It was an error Control Group, none, , 6 months, standard care, 46, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/01/2019 It was an error Control Group, standard care, , 6 months, Usual care, 46, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/01/2019 It was a missunderstanding TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, BUEA, 00237, Cameroon, , 01 Mar 2018, 00237677034635, ketchajialice2015@gmail.com, 5757_4048_4737.pdf TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, BUEA, 00237, Cameroon, , 01 Mar 2018, 00237677034635, irbfhs@gmail.com, 5757_4048_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 30/01/2019 I did not understand KETCHAJI ALICE, Central town, YAOUNDE, , Cameroon, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 21/02/2019 Issue of missunderstanding Retention and adherence among adolescents living with HIV: an overview of the Centre region of Cameroon The HIV/AIDS mobile phone and home visit trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 21/02/2019 It was an error 31 Dec 2018 01 Jul 2018
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 21/02/2019 It was an error 31 Dec 2018 01 Feb 2019
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 21/02/2019 It was an error 01 Feb 2019
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 21/02/2019 i DIT NOT UNDERSTAND KETCHAJI ALICE, Central town, YAOUNDE, , Cameroon, Self Funded, KETCHAJI ALICE, Central town, YAOUNDE, , Cameroon, Funding Agency,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 21/02/2019 I did not understand KETCHAJI ALICE, Central town, YAOUNDE, , Cameroon, Funding Agency, KETCHAJI ALICE, Central town, YAOUNDE, , Cameroon, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/02/2019 I did not understand TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, BUEA, 00237, Cameroon, , 01 Mar 2018, 00237677034635, irbfhs@gmail.com, 5757_4048_4737.pdf TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, BUEA, 00237, Cameroon, , 01 Mar 2018, 00237677034635, ketchajialice2015@gmail.com, 5757_4048_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/02/2019 I thougth that is was my email that was asking TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, BUEA, 00237, Cameroon, , 01 Mar 2018, 00237677034635, ketchajialice2015@gmail.com, 5757_4048_4737.pdf TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, BUEA, 00237, Cameroon, , 01 Mar 2018, 00237677034635, irbfhs@gmail.com, 5757_4048_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/02/2019 error 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, 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., 45,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/02/2019 It was an error 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., 45, 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,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 21/02/2019 I dit not understand Results Available URL, Result URL Hyperlink, link to protocole
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 21/02/2019 I did not well understand Result Posting Date Result Posting Date; adverse event
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 21/02/2019 I did not well understand First Journal Publication Date First Journal Publication Date, outcome measure description
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 21/02/2019 I did not well understand Study Protocol Study Protocol, Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/03/2019 We corrected it and went back to the University to change TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, BUEA, 00237, Cameroon, , 01 Mar 2018, 00237677034635, irbfhs@gmail.com, 5757_4048_4737.pdf TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, BUEA, 00237, Cameroon, , 01 Mar 2018, 00237677034635, irbfhs@gmail.com, 5757_5294_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 20/04/2019 Updated information on secondary outcome Secondary Outcome, adherence rate and retention rate, 6 months Secondary Outcome, adherence rate, retention rate and viral load count, change of treatment regimen, 6 months
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/04/2019 This email is the one available on the document of approval attached TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, BUEA, 00237, Cameroon, , 01 Mar 2018, 00237677034635, irbfhs@gmail.com, 5757_5294_4737.pdf TRUE, Faculty of Health Sciences Institutional Review Board, Faculty of Health Sciences, University of Buea, P.O Box 12, BUEA, 00237, Cameroon, , 01 Mar 2018, 00237677034635, irbfhs@gmail.com, 5757_5356_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 20/04/2019 For funding source to match KETCHAJI ALICE, Central town, YAOUNDE, , Cameroon, Self Funded, Sel Funded, Central town, YAOUNDE, , Cameroon, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 20/04/2019 Information was missing URL, Result URL Hyperlink, link to protocole 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
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 20/04/2019 Information was missing Result Posting Date; adverse event At the mid-term of intervention and 2 months after end line
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 20/04/2019 Information was missing First Journal Publication Date, outcome measure description The Data shall be openly available
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 20/04/2019 Not applicable Not applicable