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.: PACTR202310485136014 Date of Approval: 19/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effectiveness of an m-Health intervention on the sexual and reproductive health of in-school adolescents: A cluster randomized controlled trial in Nigeria
Official scientific title The effectiveness of an m-Health intervention on the sexual and reproductive health of in-school adolescents: A cluster randomized controlled trial in Nigeria
Brief summary describing the background and objectives of the trial Globally, adolescents aged 10 to 19 years make up about 16% of the population. This age group makes up a higher proportion of sub-Saharan Africa and Nigeria, accounting for 23% and 22.3% respectively. Sexual and Reproductive Health (SRH) issues, including sexually transmitted infections and unintended pregnancies, account for a significant proportion of disease burden among adolescents. A 12-year review of Nigerian adolescents sexual practices and behaviours found that they engage in risky sexual behaviours consisting of early sexual debut, unsafe sexual practices, and concurrent multiple sexual partners. There is growing evidence to show that SRH of adolescents can be improved through Comprehensive sexuality education (CSE).(5) The CSE curriculum may also be known as "life skills," "family life," or "HIV education” or "holistic sexuality education" implying the difference in the emphasis of the curricula. The policy of the Nigerian government at the national level identifies the pressing SRH needs of adolescents and has acted on its policy commitments by implementing a near-nationwide CSE. Family Life and HIV Education (FLHE) is the form of CSE being implemented by the government into school curricula at the basic and secondary school levels in Nigeria, in addition to teacher's training institutions; its main aim is to prevent HIV/AIDS through awareness and education. Given the limitations associated with the delivery of FLHE in Nigeria which is mainly via didactic physical lectures, and consequently, low nation-wide implementation and uptake, there is a need to revolutionize information access through mHealth in the country. In line with this, this study implemented a mHealth-based CSE curriculum over 12 weeks and assessed its effect on the SRH, attitude, and sexual behaviour of in-school adolescents in Ilorin, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied The effectiveness of an m-Health intervention on sexual and reproductive health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Comprehensive sexuality education through mHealth technology
Anticipated trial start date 10/02/2020
Actual trial start date 10/02/2020
Anticipated date of last follow up 28/08/2020
Actual Last follow-up date 28/08/2020
Anticipated target sample size (number of participants) 1280
Actual target sample size (number of participants) 1280
Recruitment status Completed
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group School as usual condition 12 weeks Participants in the control group were not exposed to the mHealth-based intervention. Instead, they were to continue with the usual classroom-based CSE according to the existing school curriculum during the intervention period. 640 Placebo
Experimental Group Access to the mHealth based comprehensive sexuality education 12 weeks Participants in the intervention group were given access to an online 12-module comprehensive sexuality education curriculum. Each participant was given a username (not linked to any personal identifier) and password (which each user could change) to access the curriculum online. 640
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible to participate, schools had to be registered with the Kwara State Ministry of Education In-school adolescents (aged 10-19 years) in senior secondary school and who had access to the internet at least once a week throughout the study duration were eligible to participate Students who had cognitive or visual impairments were excluded from the trial Adolescent: 13 Year-18 Year 10 Year(s) 18 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 30/07/2019 UITH Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road, Oke - Ose, P.M.B 1459, Ilorin, Kwara State Ilorin 1459 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome was participants mean scores in SRH knowledge, SRH attitude and RSB of participants Measured at baseline, immediately after the intervention and 3 months after the intervention
Secondary Outcome Factors influencing the primary outcomes (SRH knowledge, attitude and sexual behaviour) using multivariate analysis using binary logistic regression. Immediately after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kwara State Ministry of Education and Human Capital Development Lajonrin Street. P.M.B 1391, Ilorin Kwara State. Ilorin Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Not applicable Ilorin Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Not applicable Not applicable Not applicable Nigeria Trial was not sponsored
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwatosin Akande akande.wuraola@gmail.com +2348034782813 Department of Epidemiology and Community Health, University of Ilorin
City Postal code Country Position/Affiliation
Ilorin Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries Oluwatosin Akande akande.wuraola@gmail.com +2348034782813 Department of Epidemiology and Community Health, University of Ilorin Teaching Hospital, Ilorin, Nigeria
City Postal code Country Position/Affiliation
Ilorin Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Oluwatosin Akande akande.wuraola@gmail.com +2348034782813 Department of Epidemiology and Community Health, University of Ilorin Teaching Hospital, Ilorin, Nigeria
City Postal code Country Position/Affiliation
Ilorin Nigeria Resident Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Additional documents such as the study protocol will be available. The data will be available beginning 6 months and ending 30 months following article publication. Informed Consent Form 24 months The data will be shared with investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose to achieve aims in the approved proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 12/10/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 12/10/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information