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

Gonorrhea Clinical Trial

— FEDE-ITS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05727033
• Other study ID #: 4R22/162
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: September 2023

Study information

• Verified date: November 2022
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: David Pedrazas-López, PhD, MD
• Phone: #34 660186126
• Email: david.pedrazas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Chlamydia Infections
• Communicable Diseases
• Gonorrhea
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Human Papillomavirus (HPV)
• Infections
• Sexually Transmitted Diseases
• Syphilis
• Syphilis Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	CAP Alcarràs	Alcarràs	Lleida
Spain	CAP Balaguer	Balaguer	Lleida
Spain	CAP Gótic	Barcelona
Spain	CAP Sant Andreu de la Barca	Sant Andreu de la Barca	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Role in sexual intercourse.	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
Secondary	Role in sexual intercourse.	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
Secondary	Role in sexual intercourse.	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