Home » Trials » SLCTR/2014/003
A health educational intervention to reduce risky sexual behaviors among undergraduates
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SLCTR Registration Number
SLCTR/2014/003
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A health educational intervention to reduce risky sexual behaviors among undergraduates
Public Title of Trial
A health education intervention to reduce risky sexual behaviors among undergraduates
Disease or Health Condition(s) Studied
Risky sexual behavior among undergraduates
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
UTN1111-1151-0496
Any other number(s) assigned to the trial and issuing authority
P202/12/2013 (Ethical Review Committee, University of Kelaniya)
What is the research question being addressed?
Can a health education intervention reduce risky sexual behavior among undergraduates?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
•The health educational intervention has been developed using a health promotional curriculum developed by ETR associates in California. (ETR- Education , Training and Research Associates. ETR is a nonprofit, science-based organization that works to improve the physical, social and emotional health of individuals, families and communities by advancing the work of health, education and social services providers through high-quality research, publications, information resources, training and programs).This has been modified to suit our study population and objectives of the study.
•Modified intervention includes interactive programs. It will be implemented as a two day program. One session will take around four hours. A group of 30 students will participate for a session. There will be 10 groups to fulfill the study sample.
•The intervention will be implemented separately to different streams.
•The Control group consists of undergraduates (from all five streams), studying in another university from the western province.They will not be subjected to any intervention.
The universities will be randomly selected.
Inclusion criteria
• Undergraduates studying in second or third year in a selected state university of Western province. • Five faculties including all study streams will be included
Exclusion criteria
• Undergraduates from foreign countries
• Clergymen undergraduates
Primary outcome(s)
|
1.
•Reduction of, behaviors leading unintentional pregnancies and STI transmission will be measured •Pre-intervention behavior will be measured using a self administered questionnaire before the intervention. Post interventional behavior will be measured using the same questionnaire. The reduction will be measured by analyzing post interventional data between intervention and control groups. |
[ After three months ] |
Secondary outcome(s)
|
1.
Knowledge and attitudes on some aspects of reproductive health |
[ after three months ] |
Target number/sample size
300 controls, 300 subjects
Countries of recruitment
Sri Lanka
Anticipated start date
2014-03-15
Anticipated end date
2014-08-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2013-12-11
Approval number
P/202/12/2013
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
T.A.U.A.P.Perera
Registrar in Community Medicine
Faculty of Medicine, Ragama
0112953411
0718043649
upuliaruna@yahoo.com
Contact Person for Public Queries
Prof. Chrishantha Abeysena,
Professor in Community Medicine
Faculty of Medicine, Ragama
0112953411
0710822848
chrishanthaabeysena@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
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
