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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: SLCTR
Last refreshed on: 21 June 2021
Main ID:  SLCTR/2021/014
Date of registration: 2021-06-09
Prospective Registration: Yes
Primary sponsor:
Public title: 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.
Scientific title: 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
Date of first enrolment: 2021-06-10
Target sample size: 300 (150 in each arm)
Recruitment status: Pending
URL:  https://slctr.lk/trials/slctr-2021-014
Study type:  Interventional
Study design:  Randomized controlled trial  
Phase:  Not Applicable
Countries of recruitment
Sri Lanka
Contacts
Name: Dr Amanthi Bandusena    
Address:  Health Promotion Bureau Colombo 08
Telephone: 0112696606
Email: amanthisl@hotmail.com
Affiliation:  Consultant Community Physician
Name: Dr HDJJ Gunasekera   
Address:  Health Promotion Bureau Colombo 08
Telephone: 0112696606
Email: janjeewa@gmail.com
Affiliation:  Medical Officer
Key inclusion & exclusion criteria
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


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Sexual and Reproductive Health
Intervention(s)
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.

Primary Outcome(s)
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)
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]
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]
Change in scores of the Risky Sexual Behaviour component of the questionnaire [After 6 weeks (conclusion of the intervention) and after 3 months]
Secondary ID(s)
Source(s) of Monetary Support
Self
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 12/12/2019
Contact:
ethicscommitteemfc@gmail.com
ethicscommitteemfc@gmail.com
0112695300
ethicscommitteemfc@gmail.com
Results
Results available:
Date Posted:
Date Completed:
URL:
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