Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections (FEDE-ITS)

February 3, 2023 updated by: Jordi Gol i Gurina Foundation

Extraordinarily Fun Training Project in Compulsory Secondary Education-Sexually Transmitted Infections: Educational Intervention on STI in Adolescents From 1st&2nd Year of Compulsory Secondary Education Incorporating the Gender Perspective

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Sexually transmitted infections (STIs) are a public health problem. Every day, more than 1 million people are infected worldwide, most of whom are asymptomatic. The most common STIs are chlamydia, gonorrhea, syphilis and trichomoniasis, which are easily curable. Other highly prevalent infections are genital herpes and human papillomavirus. However, there is no clear evidence regarding the effectiveness of interventions. Due to the serious epidemiological situation regarding sexually transmitted infections, actions are needed to mitigate the exponential growth in the incidence of these infections.

Objective: To evaluate the impact of an intervention on sexual education in pupils of 1st and 2nd year of Compulsory Secondary Education (ESO), assessing the knowledge about the five most prevalent STIs, the knowledge of barrier methods, and practice of STI risky behaviours.In addition, to analyze whether biological sex conditions the role of submission in women versus the role of dominance in men.

Trial Design: Cluster randomised clinical trial.

Location: It will be carried out in the Basic Health Area of Sant Andreu de la Barca (Baix Llobregat Nord), Balaguer (Noguera), Alcarràs (Segrià) and Barcelona (Barcelona), in Catalonia, Spain.

Participants: Students enrolled in secondary education schools in ESO 1st and 2nd years who meet the selection criteria.

Instruments: As an intervention to be evaluated, an innovative educational methodology with a gender perspective will be carried out on adolescents through discussion with photographs, posters and a short film. No training intervention will be carried out in the control group during the study period, following the instructions of the Department of Education of the Generalitat of Catalonia.

Variables: Evaluation in both groups of knowledge, attitudes and risk practices related to STIs through a pre-intervention, post-intervention and post-post-intervention questionnaire validated in previous studies.

Applicability: The aim is to explore new educational methods to improve knowledge, attitudes and risk practices for STIs in future sexual relationships. Gender-sensitive training could contribute to freer and more egalitarian relationships and reduce the likelihood of violence against women that develops in adolescence.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08002
    • Barcelona
      • Sant Andreu de la Barca, Barcelona, Spain, 08740
        • CAP Sant Andreu de la Barca
        • Contact:
    • Lleida
      • Alcarràs, Lleida, Spain, 25180
      • Balaguer, Lleida, Spain, 25600
        • CAP Balaguer
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • pupils refusing to participate
  • families refusing to participate
  • school administration refusing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention Group

The 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.
Behavioral: Participatory teaching group

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.

Other Names:
  • Extraordinarily Fun Training in compulsory secondary Education - Sexually Transmitted Infections methodology
  • FEDE-ITS® methodology
SHAM_COMPARATOR: Control Group
Following 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.
Behavioral: Sham control group
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.
Other Names:
  • Sham intervention group
  • Health and school program (Department of Health. Government of Catalonia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of the five most prevalent STIs
Time Frame: pre-intervention at the baseline day

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
Time Frame: end-of-intervention at the same day

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
Time Frame: post-intervention assessments six months after the intervention

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.
Time Frame: pre-intervention at the baseline day

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.
Time Frame: end-of-intervention at the same day

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.
Time Frame: post-intervention assessments six months after the intervention

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.
Time Frame: pre-intervention at the baseline day

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.
Time Frame: end-of-intervention at the same day

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.
Time Frame: post-intervention assessments six months after the intervention

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.
Time Frame: pre-intervention at the baseline day

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.
Time Frame: end-of-intervention at the same day

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.
Time Frame: post-intervention assessments six months after the intervention

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role in sexual intercourse.
Time Frame: pre-intervention at the baseline day

Nominal qualitative variable. It will be recorded in the questionnaire using multiple-choice questions.

"If you have sex, who decides whether or not to use a barrier method of contraception (condom - female condom)? OR If you do not have sex, who do you think will decide whether or not to use * a barrier method of contraception (condom-female condom) when you do have sex Tick one.

  • Myself
  • My sexual partner
  • We decide by mutual consent
  • Other (specify)
pre-intervention at the baseline day
Role in sexual intercourse.
Time Frame: end-of-intervention at the same day

Nominal qualitative variable. It will be recorded in the questionnaire using multiple-choice questions.

"If you have sex, who decides whether or not to use a barrier method of contraception (condom - female condom)? OR If you do not have sex, who do you think will decide whether or not to use * a barrier method of contraception (condom-female condom) when you do have sex Tick one.

  • Myself
  • My sexual partner
  • We decide by mutual consent
  • Other (specify)
end-of-intervention at the same day
Role in sexual intercourse.
Time Frame: post-intervention assessments six months after the intervention

Nominal qualitative variable. It will be recorded in the questionnaire using multiple-choice questions.

"If you have sex, who decides whether or not to use a barrier method of contraception (condom - female condom)? OR If you do not have sex, who do you think will decide whether or not to use * a barrier method of contraception (condom-female condom) when you do have sex Tick one.

  • Myself
  • My sexual partner
  • We decide by mutual consent
  • Other (specify)
post-intervention assessments six months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordi Gol i Gurina Foundation

Investigators

  • Principal Investigator: David Pedrazas-López, PhD, MD, Institut Català de la Salut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2023

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

September 1, 2023

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

February 3, 2023

First Posted (ESTIMATE)

February 14, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4R22/162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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