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

09 Jun 2021

The date of last modification

Jun 09, 2021



Application Summary


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


Any other number(s) assigned to the trial and issuing authority

EC-19-130


Trial Details


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.

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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


Date of study completion


Recruitment status

Pending


Funding source

Self


Regulatory approvals

NA



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization







Secondary study sponsor (If any)







Trial Completion details


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