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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 试验地点
- 4
- 主要终点
- Use of barrier methods in sexual intercourse.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •pupils refusing to participate
- •families refusing to participate
- •school administration refusing to participate
研究组 & 干预措施
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.
干预措施: Participatory teaching group (Behavioral)
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.
干预措施: Sham control group (Behavioral)
结局指标
主要结局
Use of barrier methods in sexual intercourse.
时间窗: 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
Knowledge of different barrier methods.
时间窗: 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"
Knowledge of the five most prevalent STIs
时间窗: 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)"
Drug use during sexual intercourse.
时间窗: 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
Knowledge of the five most prevalent STIs
时间窗: 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
时间窗: 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 different barrier methods.
时间窗: 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.
时间窗: 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"
Use of barrier methods in sexual intercourse.
时间窗: 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.
时间窗: 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
Drug use during sexual intercourse.
时间窗: 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.
时间窗: 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
次要结局
- Role in sexual intercourse.(post-intervention assessments six months after the intervention)
- Role in sexual intercourse.(pre-intervention at the baseline day)
- Role in sexual intercourse.(end-of-intervention at the same day)