Clinical trial NCT05727033: Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chlamydia Infections
Gonorrhea
Syphilis Infection
Human Immunodeficiency Virus (HIV)
Human Papillomavirus (HPV)
Gender Equity
Keywords: Adolescents
sexually transmitted infections
primary health care
sexual health
health education
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge of the five most prevalent STIs
timeFrame: pre-intervention at the baseline day
measure: Knowledge of the five most prevalent STIs
timeFrame: end-of-intervention at the same day
measure: Knowledge of the five most prevalent STIs
timeFrame: post-intervention assessments six months after the intervention
measure: Knowledge of different barrier methods.
timeFrame: pre-intervention at the baseline day
measure: Knowledge of different barrier methods.
timeFrame: end-of-intervention at the same day
measure: Knowledge of different barrier methods.
timeFrame: post-intervention assessments six months after the intervention
measure: Use of barrier methods in sexual intercourse.
timeFrame: pre-intervention at the baseline day
measure: Use of barrier methods in sexual intercourse.
timeFrame: end-of-intervention at the same day
measure: Use of barrier methods in sexual intercourse.
timeFrame: post-intervention assessments six months after the intervention
measure: Drug use during sexual intercourse.
timeFrame: pre-intervention at the baseline day
measure: Drug use during sexual intercourse.
timeFrame: end-of-intervention at the same day
measure: Drug use during sexual intercourse.
timeFrame: post-intervention assessments six months after the intervention
Secondary outcomes:
measure: Role in sexual intercourse.
timeFrame: pre-intervention at the baseline day
measure: Role in sexual intercourse.
timeFrame: end-of-intervention at the same day
measure: Role in sexual intercourse.
timeFrame: post-intervention assessments six months after the intervention
Other outcomes:
Locations:
city: Sant Andreu de la Barca
country: Spain
facility: CAP Sant Andreu de la Barca
state: Barcelona
city: Alcarràs
country: Spain
facility: CAP Alcarràs
state: Lleida
city: Balaguer
country: Spain
facility: CAP Balaguer
state: Lleida
city: Barcelona
country: Spain
facility: CAP Gótic
Study officials:
affiliation: Institut Català de la Salut
name: David Pedrazas-López, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: