Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections
FEDE-ITS
1 other identifier
interventional
1,200
1 country
4
Brief Summary
Project FEDE-ITS will improve the STI knowledge and its treatment, of adolescents in the 1st and 2nd year of compulsory secondary education in the intervention group compared to compared to the control group, and will modify the sexual risk practices and the perception of risky practices of alcohol and other drug use during sex of participants in the intervention group compared to the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedFebruary 14, 2023
November 1, 2022
6 months
November 23, 2022
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Knowledge of the five most prevalent STIs
Discrete quantitative variable. It will be assessed by scoring. 5 scoring items: correct answer 1 point and incorrect answer 0 points. The maximum score will be 5 points (HIV: 1 point, Chlamydia: 1 point, Syphilis or Treponema pallidum: 1 point, Gonorrhoea or Neisseria gonorrhoeae: 1 point, HPV or Papilloma Virus: 1 point), and the minimum 0 points. \- "List the Sexually Transmitted Infections (STIs) you know, Tick one: * HIV * Candida albicans * Gonorrhoea * Chlamydia * Escherichia coli * Treponema / Syphilis * COVID-19 * Human Papilloma (HPV)"
pre-intervention at the baseline day
Knowledge of the five most prevalent STIs
Discrete quantitative variable. It will be assessed by scoring. 5 scoring items: correct answer 1 point and incorrect answer 0 points. The maximum score will be 5 points (HIV: 1 point, Chlamydia: 1 point, Syphilis or Treponema pallidum: 1 point, Gonorrhoea or Neisseria gonorrhoeae: 1 point, HPV or Papilloma Virus: 1 point), and the minimum 0 points. \- "List the Sexually Transmitted Infections (STIs) you know, Tick one: * HIV * Candida albicans * Gonorrhoea * Chlamydia * Escherichia coli * Treponema / Syphilis * COVID-19 * Human Papilloma (HPV)"
end-of-intervention at the same day
Knowledge of the five most prevalent STIs
Discrete quantitative variable. It will be assessed by scoring. 5 scoring items: correct answer 1 point and incorrect answer 0 points. The maximum score will be 5 points (HIV: 1 point, Chlamydia: 1 point, Syphilis or Treponema pallidum: 1 point, Gonorrhoea or Neisseria gonorrhoeae: 1 point, HPV or Papilloma Virus: 1 point), and the minimum 0 points. \- "List the Sexually Transmitted Infections (STIs) you know, Tick one: * HIV * Candida albicans * Gonorrhoea * Chlamydia * Escherichia coli * Treponema / Syphilis * COVID-19 * Human Papilloma (HPV)"
post-intervention assessments six months after the intervention
Knowledge of different barrier methods.
Discrete quantitative variable. It will be collected in the questionnaire using a question with multiple correct options. There will be 5 options and 2 correct. Scoring: From 0 (minimum score) to 5 points (maximum score) \- "How many barrier methods do you know? (tick the options you consider \* correct): Select all the options that apply. * Male condom * Post-coital pill * Aspirin * Abstinence * Female condom"
pre-intervention at the baseline day
Knowledge of different barrier methods.
Discrete quantitative variable. It will be collected in the questionnaire using a question with multiple correct options. There will be 5 options and 2 correct. Scoring: From 0 (minimum score) to 5 points (maximum score) \- "How many barrier methods do you know? (tick the options you consider \* correct): Select all the options that apply. * Male condom * Post-coital pill * Aspirin * Abstinence * Female condom"
end-of-intervention at the same day
Knowledge of different barrier methods.
Discrete quantitative variable. It will be collected in the questionnaire using a question with multiple correct options. There will be 5 options and 2 correct. Scoring: From 0 (minimum score) to 5 points (maximum score) \- "How many barrier methods do you know? (tick the options you consider \* correct): Select all the options that apply. * Male condom * Post-coital pill * Aspirin * Abstinence * Female condom"
post-intervention assessments six months after the intervention
Use of barrier methods in sexual intercourse.
Ordinal qualitative variable. It will be recorded in the questionnaire using a Likert scale (always, almost always, sometimes, never) \- In the case of having sex, have you used barrier methods (condom or female condom) from the very start (including oral sex), OR If you do not have sex, do you think that when you do have sex you will always use barrier methods (condom-female condom), including oral sex? Tick one. * Always * Almost Always * Sometimes * Never
pre-intervention at the baseline day
Use of barrier methods in sexual intercourse.
Ordinal qualitative variable. It will be recorded in the questionnaire using a Likert scale (always, almost always, sometimes, never) \- In the case of having sex, have you used barrier methods (condom or female condom) from the very start (including oral sex), OR If you do not have sex, do you think that when you do have sex you will always use barrier methods (condom-female condom), including oral sex? Tick one. * Always * Almost Always * Sometimes * Never
end-of-intervention at the same day
Use of barrier methods in sexual intercourse.
Ordinal qualitative variable. It will be recorded in the questionnaire using a Likert scale (always, almost always, sometimes, never) \- In the case of having sex, have you used barrier methods (condom or female condom) from the very start (including oral sex), OR If you do not have sex, do you think that when you do have sex you will always use barrier methods (condom-female condom), including oral sex? Tick one. * Always * Almost Always * Sometimes * Never
post-intervention assessments six months after the intervention
Drug use during sexual intercourse.
Qualitative ordinal variable. It will be recorded in the questionnaire using a Likert scale (always, almost always, sometimes, never) \- "If you have sex, do you use alcohol or other drugs when you have sex? OR If you do not have sex, do you think that when you do you will use \* alcohol or other drugs when you have sex? Tick one. * Always * Almost Always * Sometimes * Never
pre-intervention at the baseline day
Drug use during sexual intercourse.
Qualitative ordinal variable. It will be recorded in the questionnaire using a Likert scale (always, almost always, sometimes, never) \- "If you have sex, do you use alcohol or other drugs when you have sex? OR If you do not have sex, do you think that when you do you will use \* alcohol or other drugs when you have sex? Tick one. * Always * Almost Always * Sometimes * Never
end-of-intervention at the same day
Drug use during sexual intercourse.
Qualitative ordinal variable. It will be recorded in the questionnaire using a Likert scale (always, almost always, sometimes, never) \- "If you have sex, do you use alcohol or other drugs when you have sex? OR If you do not have sex, do you think that when you do you will use \* alcohol or other drugs when you have sex? Tick one. * Always * Almost Always * Sometimes * Never
post-intervention assessments six months after the intervention
Secondary Outcomes (3)
Role in sexual intercourse.
pre-intervention at the baseline day
Role in sexual intercourse.
end-of-intervention at the same day
Role in sexual intercourse.
post-intervention assessments six months after the intervention
Study Arms (2)
Intervention Group
ACTIVE COMPARATORThe intervention of training-participatory activity will last between 45 and 60 minutes, divided into theoretical training of 15-30 minutes followed by discussion training of 30 minutes. Based on the projection of the posters, photographs and the short film, the pupils will be asked to participate and work on the problem of STIs as well as possible solutions. The group techniques of photo-talk and presentation with a discussion using the short film will be used. Finally, the training includes Kahoot®, a tool for learning and reviewing concepts in a fun, quiz-like way. Four multiple-choice questions have been included. They will learn in a participatory way about STIs, risk practices, barrier methods and health resources to consult or go to in case of suspicion of contracting an STI. For the activity, a sequence of drawings and signs has been designed to put STIs, their causes and how to prevent infection into context.
Control Group
SHAM COMPARATORFollowing the indications of the Department of Education and the "Health and School" Programme, non specific training intervention will be carried out in the control group out during the study period.
Interventions
The intervention will be called FEDE-ITS® methodology. This methodology is self-designed and self-developed and draws on previous work in equivalent populations. It is based on teaching in a participatory way knowledge and healthy attitudes related to the five most prevalent STIs in the province of Barcelona and Lleida, the methods to avoid contagion, and the health resources that can be consulted in case of infection, contact with an infected person or concerns. In addition, a gender perspective is incorporated to contribute to freer and more egalitarian relationships and reduce the likelihood of violence against women which develops in adolescence. The cross-cutting themes of the training are: health, pleasure, self-esteem, knowledge-based freedom of choice, equality between people and respect for sexual freedom. Therefore, the ultimate goal is to prevent abusive power relations and macho violence.
The "Health and School" program was implemented to promote health in schools, and for this reason the program's nurse attends annually to address problems related to sexual affective health within the curricular itinerary of each school, but not specifically on sexually transmitted infections or gender perspective.
Eligibility Criteria
You may qualify if:
- pupils in the 1st and 2nd years of compulsory secondary education in the municipalities of Sant Andreu de la Barca, Balaguer, Alcarràs and Barcelona
- prior authorisation of the school administration,
- prior authorisation of the pupil
- prior authorisation of the parents/legal guardians by submitting the information sheet and collecting the informed consent.
You may not qualify if:
- pupils refusing to participate
- families refusing to participate
- school administration refusing to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CAP Sant Andreu de la Barca
Sant Andreu de la Barca, Barcelona, 08740, Spain
CAP Alcarràs
Alcarràs, Lleida, 25180, Spain
CAP Balaguer
Balaguer, Lleida, 25600, Spain
CAP Gótic
Barcelona, 08002, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Pedrazas-López, PhD, MD
Institut Català de la Salut
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The person in charge of analyzing the data collected in the study will not know if the participants belong to the intervention group or the control group, which will be identified with an alphanumeric code.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2022
First Posted
February 14, 2023
Study Start
March 1, 2023
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
February 14, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share