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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05727033
Acronym
FEDE-ITS
Enrollment
1200
Registered
2023-02-14
Start date
2023-03-31
Completion date
2023-09-30
Last updated
2023-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALParticipatory 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.

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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.

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.

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of the five most prevalent STIspre-intervention at the baseline dayDiscrete 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 dayDiscrete 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 dayOrdinal 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 dayQualitative 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

MeasureTime frameDescription
Role in sexual intercourse.pre-intervention at the baseline dayNominal 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)

Countries

Spain

Contacts

Primary ContactDavid Pedrazas-López, PhD, MD
david.pedrazas@gmail.com#34 660186126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026