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.: PACTR202206840350306 Date of Approval: 02/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title HIV prevention strategies among adolescents: Use of mobile technology to enhance the capacity of teachers to teach Family Life and HIV Education in Nigeria
Official scientific title HIV prevention strategies among adolescents: Use of mobile technology to enhance the capacity of teachers to teach Family Life and HIV Education in Nigeria
Brief summary describing the background and objectives of the trial Family Life and HIV Education (FLHE) was the Ministry of Education’s intervention to prevent HIV among young people in Nigeria. This curriculum was first implemented in 2003. However, there have been challenges mitigating the implementation. An important challenge is the low capacity of teachers to adequately deliver the contents of the developed curriculum. Given the significant roles teachers play in the implementation of this important prevention program, it is important that they have the capacity to deliver. This study therefore intends to test the feasibility of enhancing the self-reported capacities of teachers to deliver FLHE curriculum through mobile technology. This study will be a multi-phase study. In phase 1, a cross sectional study utilizing qualitative methods will be conducted to adapt a teacher-focused curriculum. In phase 2, the mobile app to deploy the curriculum will be developed. This will be followed by a pretesting of the curriculum and the mobile app. In phase 3, an experimental cluster randomized design with three arms will be conducted. Questionnaire assessment will be conducted pre-intervention, immediately after intervention and three months after the intervention. Questionnaires will be deployed through RedCap. This study will provide useful information on the feasibility of using mobile technology in improving the self-reported capacities of teachers to deliver FLHE curriculum.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) mFLHE Study
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 10/01/2022
Actual trial start date 07/02/2022
Anticipated date of last follow up 27/06/2022
Actual Last follow-up date 30/06/2022
Anticipated target sample size (number of participants) 138
Actual target sample size (number of participants) 145
Recruitment status Completed
Publication URL https://www.sciencedirect.com/science/article/pii/S277265332300014X
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 Permuted block randomization Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mobile App delivered Family Life and HIV Education curruculum The modules for each week were open from sunday to Saturday. Participants had the choice of viewing and reading the information at any time during this period. they could also do it gradually. Participants had two Modules to go through every week The entire period was four weeks A mobile application was designed. The Family Life and HIV Education (FLHE) curriculum was adapted to be delivered through the mobile application. The FLHE curriculum is the Nigerian Federal Ministry of Education's prevention program for HIV among in-school and out-of-school adolescents. This program was scaled up to National level in 2003. Training teachers to deliver this is one of the components of the program. 50
Control Group Standard group Participants had four hours in-person contact sessions a week Four weeks The participants were exposed to the FLHE curriculum at a four hours in-person training sessions for four hours a week for four weeks. The same curriculum was used for the Standard group and the mobile app group. 48 Active-Treatment of Control Group
Control Group COntrol group A single in-person training session for four hours One day training Participants were trained on how to communicate with sexual and reproductive health issues with adolescents 47 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Teachers who are employed in public secondary schools Teachers who have been teaching for at least a year Teachers who have at least a NCE certificate Teachers who provide consent Teachers who do not teach one of the FLHE subjects Teachers who were newly transferred into the current school were they teach Teachers who are two years away from retirement Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 58 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 05/07/2021 Oyo State Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Oyo State Secretariat, Agodi Ibadan Ibadan PMB 5027 Nigeria
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 21/10/2021 UIUCH Ethics Committee College of Medicine
Ethics Committee Address
Street address City Postal code Country
Queen Elizabeth Road, Oritamefa Ibadan PMB 5017 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Self reported capacity of teachers to teach FLHE. And willingness of teachers to teach FLHE Pre-intervention. immediate post intervention. one month after intervention. three months after intervention
Secondary Outcome Knowledge of FLHE among teachers. Attitude of teachers towards FLHE. And Perception of FLHE among teachers Pre intervention. Immediate after intervention. One month after intervention. and Three months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Schools in Ibadan North Local Government Area Ibadan North Local govenrment area Ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Fogarty International Center and the National Institute of Child Health and Human Development 9000 Rockville Pike, Bethesda, Maryland Maryland 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor HBNU Forgarty Global Health training Program 677 Huntington Avenue Boston, MA 02115 Boston 02115 United States of America University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Adebayo emmanueladebayo2002@yahoo.com +2347060766707 Institue Of Child Health, University College Hospital
City Postal code Country Position/Affiliation
Ibadan PMB 5017 Nigeria Research Fellow. Institute of Child Health College of Medicine. University of Ibadan
Role Name Email Phone Street address
Public Enquiries Oreoluwa Olaniyan orexzgold@gmail.com +2348093916552 Institue Of Child Health, University College Hospital
City Postal code Country Position/Affiliation
Ibadan PMB 5017 Nigeria Research Officer
Role Name Email Phone Street address
Scientific Enquiries Wafaie Fawzi mina@hsph.harvard.edu +16174327598 677 Huntington Ave 11th Floor Boston 02115 MA
City Postal code Country Position/Affiliation
Boston 02115 United States of America Professor. Harvard School of Public Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data will be made available including the data dictionaries All of the individual participant data collected during the trial will be made available after de-identification The study protocol will be published on Research Gate The Data will be available 3months and ending 5years following article publications The data will only be available to researchers or investigators whose proposed use of the data has been approved by an independent review committee Study Protocol The Data will be available 3months and ending 5years following article publications The data will only be available to researchers or investigators whose proposed use of the data has been approved by an independent review committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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