Chlamydia InfectionsFEDE-ITSNCT05727033
Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections
A study testing Participatory teaching group in people with Chlamydia Infections and Gonorrhea, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 4 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Infections, Gonorrhea, Syphilis Infection
- What is being tested?
- Participatory teaching group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 4 sitesSpain
- Study dates
- Mar 2023to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- pupils refusing to participate
- families refusing to participate
- school administration refusing to participate
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
CAP Alcarràs
Alcarràs, Lleida, 25180
Neus Arola-Serra, Nurse, #34 620045954, salutconcient@gmail.com
CAP Balaguer
Balaguer, Lleida, 25600
Alicia Márquez-Vidal, Nurse, #34 619062554, amvidal23@gmail.com
CAP Gótic
Barcelona, 08002
David Pedrazas, PhD, MD, #34 933436140 ext. 1104, david.pedrazas@gmail.com
CAP Sant Andreu de la Barca
Sant Andreu de la Barca, Barcelona, 08740
Gloria Jodar-Solà, PhD, Nurse, #34 607074252, gloria.jodar@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Chlamydia Infections, Gonorrhea, Syphilis Infection, Human Immunodeficiency Virus (HIV), Human Papillomavirus (HPV), Gender Equity
- Being tested
- Participatory teaching group, Sham control group
- Keywords
- Adolescents, sexually transmitted infections, primary health care, sexual health, health education
- Medical subject headings
- Chlamydia Infections, Gonorrhea, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participatory teaching groupBehavioural
Also called Extraordinarily Fun Training in compulsory secondary Education - Sexually Transmitted Infections methodology, FEDE-ITS® methodology
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 groupBehavioural
Also called Sham intervention group, Health and school program (Department of Health. Government of Catalonia)
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | 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. Receives: Behavioral: Participatory teaching group |
| Control Group | Sham comparator | 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. Receives: Behavioral: Sham control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)"
Measured: pre-intervention at the baseline day
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)"
Measured: end-of-intervention at the same day
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)"
Measured: post-intervention assessments six months after the intervention
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"
Measured: pre-intervention at the baseline day
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"
Measured: end-of-intervention at the same day
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"
Measured: post-intervention assessments six months after the intervention
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
Measured: pre-intervention at the baseline day
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
Measured: end-of-intervention at the same day
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
Measured: post-intervention assessments six months after the intervention
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
Measured: pre-intervention at the baseline day
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
Measured: end-of-intervention at the same day
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
Measured: post-intervention assessments six months after the intervention
Secondary outcomes (3)
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)
Measured: pre-intervention at the baseline day
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)
Measured: end-of-intervention at the same day
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)
Measured: post-intervention assessments six months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chlamydia InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Pedrazas-López, PhD, MD, Principal investigator, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727033
- Sponsor's protocol ID
- 4R22/162
- Acronym
- FEDE-ITS
- Status last verified
- Nov 2022
- First submitted
- 23 Nov 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05727033
- Acronym / sponsor ID
- FEDE-ITS / 4R22/162
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Behavioral: Participatory teaching groupThe 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. |
| Control Group | Sham comparator | Behavioral: Sham control groupFollowing 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. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- pupils refusing to participate
- families refusing to participate
- school administration refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participatory teaching groupAlso: Extraordinarily Fun Training in compulsory secondary Education - Sexually Transmitted Infections methodology, FEDE-ITS® methodologyThe 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. | Behavioural | Intervention Group |
| Sham control groupAlso: Sham intervention group, Health and school program (Department of Health. Government of Catalonia)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. | Behavioural | Control Group |
Primary outcome
Knowledge of the five most prevalent STIs
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
3 secondary outcomes
Role in sexual intercourse.
Time frame: pre-intervention at the baseline day
Role in sexual intercourse.
Time frame: end-of-intervention at the same day
Role in sexual intercourse.
Time frame: post-intervention assessments six months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pedrazas-López, PhD, MD principal investigator
Institut Català de la Salut
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory teaching group in people with Chlamydia Infections and Gonorrhea, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Pedrazas-López, PhD, MD (#34 660186126, david.pedrazas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of the five most prevalent STIs (time frame: pre-intervention at the baseline day). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.