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

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05727033

Collaborator

(none)

1,200

Enrollment

Locations

Arms

Anticipated Duration (Months)

300

Patients Per Site

49.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chlamydia Infections Gonorrhea Syphilis Infection Human Immunodeficiency Virus (HIV) Human Papillomavirus (HPV) Gender Equity	Behavioral: Participatory teaching group Behavioral: Sham control group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster randomised clinical trial with the control group, unblinded and with pre-intervention, end-of-intervention and post-intervention assessments six months after the intervention. A 1:1 allocation ratio is established.Cluster randomised clinical trial with the control group, unblinded and with pre-intervention, end-of-intervention and post-intervention assessments six months after the intervention. A 1:1 allocation ratio is established.

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Knowledge of the five most prevalent STIs [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)"
Knowledge of the five most prevalent STIs [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)"
Knowledge of the five most prevalent STIs [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)"
Knowledge of different barrier methods. [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"
Knowledge of different barrier methods. [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"
Knowledge of different barrier methods. [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"
Use of barrier methods in sexual intercourse. [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
Use of barrier methods in sexual intercourse. [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
Use of barrier methods in sexual intercourse. [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
Drug use during sexual intercourse. [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
Drug use during sexual intercourse. [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
Drug use during sexual intercourse. [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

Secondary Outcome Measures

Role in sexual intercourse. [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)
Role in sexual intercourse. [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)
Role in sexual intercourse. [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CAP Sant Andreu de la Barca	Sant Andreu de la Barca	Barcelona	Spain	08740
2	CAP Alcarràs	Alcarràs	Lleida	Spain	25180
3	CAP Balaguer	Balaguer	Lleida	Spain	25600
4	CAP Gótic	Barcelona		Spain	08002