Home » Trials » SLCTR/2021/014
A Cluster-Randomized Trail (CRT) to compare the effectiveness of a Facebook-based intervention to improve knowledge, attitude, and skills on sexual and reproductive health among youth in vocational training institutions in the Western province
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SLCTR Registration Number
SLCTR/2021/014
Date of Registration
The date of last modification
Jul 02, 2021
Scientific Title of Trial
A Cluster-Randomized Trail (CRT) to compare the effectiveness of a Facebook-based intervention to improve knowledge, attitude, and skills on sexual and reproductive health among youth in vocational training institutions in the Western province
Public Title of Trial
A Cluster-Randomized Trail (CRT) to compare the effectiveness of a Facebook-based intervention to improve knowledge, attitude, and skills on sexual and reproductive health among youth in vocational training institutions in the Western province.
Disease or Health Condition(s) Studied
Sexual and Reproductive Health
Scientific Acronym
None
Public Acronym
None
Brief title
Sexual and Reproductive Health Education through Social Media
Universal Trial Number
U1111-1266-8858
Any other number(s) assigned to the trial and issuing authority
EC-19-130
What is the research question being addressed?
Is Facebook effective in teaching sexual and reproductive health to youth?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Applicable
Intervention(s) planned
Study setting: This is a Facebook-based intervention delivering a Sexual and Reproductive health communication package for youth following training courses at National Youth Services Council training institutions in the Western province. Method of randomization: Cluster randomization. Intervention: Communication package for the intervention was developed in the component III of the larger study in consultation with an expert panel comprising of reproductive health experts, communication experts, medical educators, health communication and promotion specialists. The content is based on the ‘Technical guide on Comprehensive Sexuality Education’ by the UNESCO. The content was culturally adopted by the expert panel. The communication package includes videos, picture posts and text descriptions. Students of randomly selected clusters will be recruited to the intervention through a ‘Secret Facebook group’. Communication material will be posted by the principal investigator during the 6 weeks of intervention. Engagement with posts will be encouraged by the principal investigator throughout the course. Control: This includes students following routine training courses (current practice). There are no formal or ad-hoc Sexual and Reproductive Health (SRH) training programmes conducted alongside routine training courses (carpentry, beauty culture, mass media etc.) offered by National Youth Services Council training institutions.
Inclusion criteria
• Students that are enrolled for training courses longer than 6 months at the National Youth Services Council • Student who have at least 5 months left in their respective training course. • Male and females between 16 – 24 years of age • Students who are already having a Facebook account and have been logged-in at least twice in last week.
Exclusion criteria
• Students with visual or hearing impairments • Students who have got transferred to the particular institution in the middle of a training course
Primary outcome(s)
|
1.
Change in the level of knowledge of Sexual and Reproductive Health. The assessment will be done by a self-administered questionnaire constating of 40 ‘True’ / ‘False’ questions. The median score will be taken as the cut-off limit for adequate knowledge. The change in percentage of students with adequate knowledge will be statistically compared between the intervention and control arm. The questionnaire was developed based on the ‘technical guide on Comprehensive Sexuality Education’ by the UNESCO. The items of the questionnaire were generated according to the key messages communicated by the communication package. The face and content validity of the questionnaire was maintained by comprehensive literature survey, expert panel inputs and several rounds of refinement by using a modified Delphi method. |
[ After 6 weeks (conclusion of the intervention) and after 3 months ] |
Secondary outcome(s)
|
1.
Change in scores obtained from the level of Attitudes of Sexual and Reproductive Health component of the questionnaire |
[ After 6 weeks (conclusion of the intervention) and after 3 months ] |
|
2.
Change in scores of the level of Skills of Sexual and Reproductive Health component of the questionnaire |
[ After 6 weeks (conclusion of the intervention) and after 3 months ] |
|
3.
Change in scores of the Risky Sexual Behaviour component of the questionnaire |
[ After 6 weeks (conclusion of the intervention) and after 3 months ] |
Target number/sample size
300 (150 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2021-06-10
Anticipated end date
2021-06-25
Date of first enrollment
2021-06-11
Date of study completion
Recruitment status
Recruiting
Funding source
Self
Regulatory approvals
NA
Status
Approved
Date of Approval
2019-12-12
Approval number
EC-19-130
Details of Ethics Review Committee
| Name: | Ethics approval from the ERC – Faculty of Medicine, University of Colombo |
| Institutional Address: | Faculty of Medicine, University of Colombo |
| Telephone: | 0112695300 |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr HDJJ Gunasekera
Medical Officer
Health Promotion Bureau
Colombo 08
0112696606
0772842678
janjeewa@gmail.com
Contact Person for Public Queries
Dr Amanthi Bandusena
Consultant Community Physician
Health Promotion Bureau
Colombo 08
0112696606
077 776 8887
amanthisl@hotmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
