Sexual BehaviorIYGNCT07208045
Cultural Adaptation, Validation, and Evaluation of the Programme for Promotion of Healthy Affective-Sexual Behaviours in Adolescents (IYG)
A study testing Es tu juego: decide bien (IYG) in people with Sexual Behavior and Sexually Transmitted Disease (STD), run by University of Seville at 1 site in Spain.
Trial summary
The investigators are writing to inform participants about a study being carried out by a research group from the University of Granada and the University of Seville, in which the participant's son/daughter is invited to participate. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Sexually Transmitted Disease (STD), Condom Use
- What is being tested?
- Es tu juego: decide bien (IYG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents aged between 11 and 14 years enrolled in compulsory secondary education (E.S.O).
- Access to a computer and internet at their educational centre.
Who cannot join
- Presence of linguistic, cognitive, or sensory barriers that prevent completion of the questionnaire
- Participation in another programme aimed at preventing affective-sexual risk behaviours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marta Lima Serrano, Full professor contact
Spain1 site
IES Numancia
Barcelona, Santa Coloma de Gramenet, 08921
Alba Sierra Yagüe, 652260353, Albbii.sy@gmail.com
Alba Sierra Yagüe
About this study
Official title: Es tu Juego: Decide Bien [It's Your Game: Keep It Real]. Cultural Adaptation, Validation, and Evaluation of the Programme for Promotion of Healthy Affective-Sexual Behaviours in Adolescents
The investigators are writing to inform participants about a study being carried out by a research group from the University of Granada and the University of Seville, in which the participant's son/daughter is invited to participate. The study has been approved by the Provincial Research Ethics Committee of Granada under code 202499906944441.
The sole intention of the investigators is to ensure that participants receive correct and sufficient information to assess and decide whether or not to give consent for the child's participation in this study. The information sheet should be read carefully, and any questions may be addressed to the investigators.
Read more
The objective of the study is to culturally adapt the program It's Your Game: Keep it Real (IYG), which aims to prevent risky sexual and affective behaviors in adolescents. The IYG program consists of 12 lessons, each lasting 45 minutes. These lessons aim to help the child identify personal norms and boundaries regarding sexuality, recognize situations that might challenge these boundaries, and develop refusal skills to maintain them. The program also covers topics such as the characteristics of healthy and unhealthy relationships, friendships, anatomy and reproduction, the social, emotional, and physical consequences of sexual activity, the consequences of teenage pregnancy and STIs, condom and contraceptive use, and communication skills.
This adaptation will involve the child completing all 12 lessons (two lessons per week over a period of six weeks) that make up the IYG program, as well as filling out a series of questionnaires. These questionnaires will allow the investigators to assess the usability of the program in Spain (including ease of use, comprehension, acceptability, as well as aspects most liked and suggestions for improvement).
Participation is entirely VOLUNTARY AND ANONYMOUS, and consent may be withdrawn at any time, without providing any explanation and without this affecting the care the child will receive in any way.
In all cases, the CONFIDENTIALITY of the data collected will be maintained in accordance with the European Union General Data Protection Regulation (GDPR) 2016/679 and the Spanish Organic Law on the Protection of Personal Data and Guarantee of Digital Rights (LOPD-GDD) 3/2018, of December 5.
Regarding the study results, these may be shared with the scientific community through presentations, conferences, and/or publications.
The investigators express appreciation in advance for cooperation in this study.
- Conditions
- Sexual Behavior, Sexually Transmitted Disease (STD), Condom Use, Adolescent Health, Cultural Adaptation
- Being tested
- Es tu juego: decide bien (IYG)
- Keywords
- sexually behaviour, sex education, adolescents, health education, cultural adaptation, evidence-based prevention, school health
- Medical subject headings
- Sexual Behavior, Sexually Transmitted Diseases, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Es tu juego: decide bien (IYG)Behavioural
Affective-sexual education for adolescents through an gamified online and school-based program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group IYG | Experimental | The intervention group will receive the culturally adapted version of It's Your Game (IYG) educational program, which is designed to promote healthy sexual behaviors and prevent risks among adolescents. Receives: Behavioral: Es tu juego: decide bien (IYG) |
| Waiting list control group | No intervention | The control group will participate in the standard sexuality and emotional education training, corresponding to the regular curriculum implemented in the educational setting. The participants in the control group will remain on a waiting list to receive the intervention, which will be implemented once the project has been completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants maintaining abstinence from oral, vaginal, and anal sex, assessed using a self-administered questionnaire adapted from It's Your Game: Keep It Real.
The primary outcome will be assessed only in participants who have not initiated sexual activity at baseline. Three self-report items will be used to determine whether, since the initial assessment, the participant has initiated: Oral sex, Vaginal sex, Anal sex.
Each question will have a dichotomous categorical response (Yes / No). The outcome will be calculated as the number and percentage of participants who respond "No" for each type of sexual activity at the end of follow-up. Data will be presented separately by study group (intervention and control) and by type of sexual activity.
Measurement Details:
Instrument: Structured self-administered questionnaire, culturally adapted and validated in Spanish adolescent populations during the pilot phase.
Response format: Yes / No. Interpretation: A higher proportion of "No" responses indicates a better outcome (greater delay in the initiation of sexual activity).
Data aggregation method: Calculation of percentages and absolute and r
Measured: Baseline (Month 0), at the end of the first and second school year of implementation and the end of the following school year and end of follow-up (Month 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Sexual BehaviorStudies 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
- The pilot effectiveness study will be conducted through a randomised community trial with a Control Group (CG) and an Intervention Group (IG). For sample size calculation, assuming an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 300 participants are required in the first group and 300 in the second to detect a statistically significant difference between two proportions, expected to be 0.2 for group 1 and 0.1 for group 2. A 30% loss to follow-up rate has been estimated. So it is expected to recruit 600 students in each Region, Andalusia and Catalonia. The assignment of the Control Group (CG) and Intervention Group (IG) will be carried out through simple randomisation. For allocation, each educational centre will be assigned a number, and a random number generator will be used to determine its inclusion in either the CG or IG. Participants in the CG will remain on a waiting list to receive the intervention, which will be implemented once the project is completed.
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Lima-Serrano, PhD, University of Seville
- Investigators
- Alba Sierra Yagüe, Phd Student, Principal investigator, Catalan Institute of HealthMarta Lima Serrano, Full professor, Study director, University of SevilleJosé Antonio Zafra Agea, PhD, Principal investigator, Catalan Institute of HealthAna Aguilar Quesada, PhD Student, Principal investigator, San Cecilio University Hospital, GranadaMaría González Cano Caballero, PhD, Principal investigator, department of Nursing, Faculty of Health Sciences, University of Granada.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208045
- Sponsor's protocol ID
- IYG2024
- Acronym
- IYG
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The project will generate qualitative data (focus groups with adolescents, parents, associations, public agencies, NGOs for the cultural adaptation of the IYG program) and quantitative data (usability and pilot tests with adolescents in Andalusia and Catalonia). Data, in text and table formats, will be stored in the DIGIBUG repository (Qualified Dublin Core metadata, unique identifier, version control). They will be accessible after processing, except those protected by personal data regulations, which will be embargoed. No raw or sociodemographic data will be published. Materials will have a Creative Commons license and may be reused after project completion, with up to 3 years embargo for doctoral theses. DIGIBUG will perform backups and ensure security. Data will be pseudonymized or anonymized (AMNESIA tool) and owned by the PI, who will ensure legal and ethical compliance.
Publications
Wiltsey Stirman S, Baumann AA, Miller CJ. The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci. 2019 Jun 6;14(1):58. doi: 10.1186/s13012-019-0898-y.
PubMed 31171014Lucassen MF, Samra R, Brown KE, Rimes KA, Nunez-Garcia A, Wallace LM. A web-based intervention to support the mental well-being of sexual and gender minoritised adolescents: Formative evaluation of Oneself. Digit Health. 2025 Mar 13;11:20552076251321057. doi: 10.1177/20552076251321057. eCollection 2025 Jan-Dec.
PubMed 40093712Escobar-Chaves SL, Shegog R, Moscoso-Alvarez MR, Markham C, Tortolero-Luna G, Peskin M, Tortolero S. Cultural tailoring and feasibility assessment of a sexual health middle school curriculum: a pilot test in Puerto Rico. J Sch Health. 2011 Aug;81(8):477-84. doi: 10.1111/j.1746-1561.2011.00617.x.
PubMed 21740433Virzi RA. Refining the Test Phase of Usability Evaluation: How Many Subjects Is Enough? Human Factors: The Journal of the Human Factors and Ergonomics Society. 1992; 1; 34(4): 457-68. https://2024.sci-hub.box/3857/2afb54700f6961ae637e388c3f96891c/virzi1992.pdf
Vargas-Martinez AM, Guillen-Martinez D, Domingo Perez T, Soilan Enriquez A, Zafra-Agea JA, Hoyos Cillero I, Lima-Serrano M, Tarrino-Concejero L. Analysis of the management function of the school nurse in Spain: use of records and interaction with primary care, the educational community and other institutions. Enferm Clin (Engl Ed). 2025 Sep-Oct;35(5):502200. doi: 10.1016/j.enfcle.2025.502200. Epub 2025 May 22.
PubMed 40412717Agyei FB, Kaura DK, Bell JD. Parent-adolescent sexual and reproductive health information communication in Ghana. Reprod Health. 2025 Feb 19;22(1):25. doi: 10.1186/s12978-025-01961-y.
PubMed 39972503Mukanga B, Dlamini SB, Taylor M. Cultural appropriateness of a comprehensive sexuality education programme. Implications for programme adaptation and implementation in Zambia. Sex Educ. 2025; 3;25(5): 631-46. https://doi.org/10.1080/14681811.2024.2367761
Kitzinger J. Qualitative research. Introducing focus groups. BMJ. 1995 Jul 29;311(7000):299-302. doi: 10.1136/bmj.311.7000.299.
PubMed 7633241Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
PubMed 17872937Lee SD, Iott B, Banaszak-Holl J, Shih SF, Raj M, Johnson KE, Kiessling K, Moore-Petinak N. Application of Mixed Methods in Health Services Management Research: A Systematic Review. Med Care Res Rev. 2022 Jun;79(3):331-344. doi: 10.1177/10775587211030393. Epub 2021 Jul 12.
PubMed 34253078Leech N, Onwuegbuzie A. Guidelines for conducting and reporting mixed research in the field of counseling and beyond. Journal of Counseling and Development. 2010; 88(1): 61-9. doi: 10.1002/j.1556-6678.2010.tb00151.x
Muheriwa-Matemba S, Crooks N, Hall H et al. 156. Fostering Young Adolescent Engagement in Sexual Health Research: A Youth-Led Community-Based Participatory Research in Western NY. Journal of Adolescent Health. 2025; 76(3): S81. doi: 10.1016/j.jadohealth.2024.11.172
Meherali S, Munro S, Puinean G, Salami B, Wong JP, Vandermorris A, Benoit JRA, Flicker S, Okeke-Ihejirika P, Stroulia E, Norman WV, Scott SD. Co-designing a Sexual Health App With Immigrant Adolescents: Protocol for a Qualitative Community-Based Participatory Action Research Study. JMIR Res Protoc. 2023 Mar 22;12:e45389. doi: 10.2196/45389.
PubMed 36947124Kachingwe ON, Lewis Q, Offiong A, Smith BD, LoVette A, Powell TW. Using the intervention mapping for adaption framework to adapt an evidence-based sexual health intervention for youth affected by trauma. BMC Public Health. 2023 Jun 1;23(1):1052. doi: 10.1186/s12889-023-15984-2.
PubMed 37264451Resnicow K, Baranowski T, Ahluwalia JS, Braithwaite RL. Cultural sensitivity in public health: defined and demystified. Ethn Dis. 1999 Winter;9(1):10-21.
PubMed 10355471
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Es tu Juego: Decide Bien [It's Your Game: Keep It Real]. Cultural Adaptation, Validation, and Evaluation of the Programme for Promotion of Healthy Affective-Sexual Behaviours in Adolescents
- ClinicalTrials.gov ID
- NCT07208045
- Acronym / sponsor ID
- IYG / IYG2024
- Conditions
- Sexual Behavior, Sexually Transmitted Disease (STD), Condom Use, Adolescent Health, Cultural Adaptation
- Keywords
- sexually behaviour, sex education, adolescents, health education, cultural adaptation, evidence-based prevention, school health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Oct 2025 (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.
The investigators are writing to inform participants about a study being carried out by a research group from the University of Granada and the University of Seville, in which the participant's son/daughter is invited to participate. The study has been approved by the Provincial Research Ethics Committee of Granada under code 202499906944441.
The sole intention of the investigators is to ensure that participants receive correct and sufficient information to assess and decide whether or not to give consent for the child's participation in this study. The information sheet should be read carefully, and any questions may be addressed to the investigators.
The objective of the study is to culturally adapt the program It's Your Game: Keep it Real (IYG), which aims to prevent risky sexual and affective behaviors in adolescents. The IYG program consists of 12 lessons, each lasting 45 minutes. These lessons aim to help the child identify personal norms and boundaries regarding sexuality, recognize situations that might challenge these boundaries, and develop refusal skills to maintain them. The program also covers topics such as the characteristics of healthy and unhealthy relationships, friendships, anatomy and reproduction, the social, emotional, and physical consequences of sexual activity, the consequences of teenage pregnancy and STIs, condom and contraceptive use, and communication skills.
This adaptation will involve the child completing all 12 lessons (two lessons per week over a period of six weeks) that make up the IYG program, as well as filling out a series of questionnaires. These questionnaires will allow the investigators to assess the usability of the program in Spain (including ease of use, comprehension, acceptability, as well as aspects most liked and suggestions for improvement).
Participation is entirely VOLUNTARY AND ANONYMOUS, and consent may be withdrawn at any time, without providing any explanation and without this affecting the care the child will receive in any way.
In all cases, the CONFIDENTIALITY of the data collected will be maintained in accordance with the European Union General Data Protection Regulation (GDPR) 2016/679 and the Spanish Organic Law on the Protection of Personal Data and Guarantee of Digital Rights (LOPD-GDD) 3/2018, of December 5.
Regarding the study results, these may be shared with the scientific community through presentations, conferences, and/or publications.
The investigators express appreciation in advance for cooperation in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The pilot effectiveness study will be conducted through a randomised community trial with a Control Group (CG) and an Intervention Group (IG). For sample size calculation, assuming an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 300 participants are required in the first group and 300 in the second to detect a statistically significant difference between two proportions, expected to be 0.2 for group 1 and 0.1 for group 2. A 30% loss to follow-up rate has been estimated. So it is expected to recruit 600 students in each Region, Andalusia and Catalonia. The assignment of the Control Group (CG) and Intervention Group (IG) will be carried out through simple randomisation. For allocation, each educational centre will be assigned a number, and a random number generator will be used to determine its inclusion in either the CG or IG. Participants in the CG will remain on a waiting list to receive the intervention, which will be implemented once the project is completed.
| Arm | Type | Receives |
|---|---|---|
| Intervention group IYG | Experimental | Behavioral: Es tu juego: decide bien (IYG)The intervention group will receive the culturally adapted version of It's Your Game (IYG) educational program, which is designed to promote healthy sexual behaviors and prevent risks among adolescents. |
| Waiting list control group | No intervention | –The control group will participate in the standard sexuality and emotional education training, corresponding to the regular curriculum implemented in the educational setting. The participants in the control group will remain on a waiting list to receive the intervention, which will be implemented once the project has been completed. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Adolescents aged between 11 and 14 years enrolled in compulsory secondary education (E.S.O).
- Access to a computer and internet at their educational centre.
Key exclusion criteria (2 listed)
- Presence of linguistic, cognitive, or sensory barriers that prevent completion of the questionnaire
- Participation in another programme aimed at preventing affective-sexual risk behaviours.
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 |
|---|---|---|
| Es tu juego: decide bien (IYG)Affective-sexual education for adolescents through an gamified online and school-based program. | Behavioural | Intervention group IYG |
Primary outcome
Proportion of participants maintaining abstinence from oral, vaginal, and anal sex, assessed using a self-administered questionnaire adapted from It's Your Game: Keep It Real.
Time frame: Baseline (Month 0), at the end of the first and second school year of implementation and the end of the following school year and end of follow-up (Month 24)
The primary outcome will be assessed only in participants who have not initiated sexual activity at baseline. Three self-report items will be used to determine whether, since the initial assessment, the participant has initiated: Oral sex, Vaginal sex, Anal sex. Each question will have a dichotomous categorical response (Yes / No). The outcome will be calculated as the number and percentage of participants who respond "No" for each type of sexual activity at the end of follow-up. Data will be presented separately by study group (intervention and control) and by type of sexual activity. Measurement Details: Instrument: Structured self-administered questionnaire, culturally adapted and validated in Spanish adolescent populations during the pilot phase. Response format: Yes / No. Interpretation: A higher proportion of "No" responses indicates a better outcome (greater delay in the initiation of sexual activity). Data aggregation method: Calculation of percentages and absolute and r
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Background: PubMed 31171014Wiltsey Stirman S, Baumann AA, Miller CJ. The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci. 2019 Jun 6;14(1):58. doi: 10.1186/s13012-019-0898-y.
- Background: PubMed 40093712Lucassen MF, Samra R, Brown KE, Rimes KA, Nunez-Garcia A, Wallace LM. A web-based intervention to support the mental well-being of sexual and gender minoritised adolescents: Formative evaluation of Oneself. Digit Health. 2025 Mar 13;11:20552076251321057. doi: 10.1177/20552076251321057. eCollection 2025 Jan-Dec.
- Background: PubMed 21740433Escobar-Chaves SL, Shegog R, Moscoso-Alvarez MR, Markham C, Tortolero-Luna G, Peskin M, Tortolero S. Cultural tailoring and feasibility assessment of a sexual health middle school curriculum: a pilot test in Puerto Rico. J Sch Health. 2011 Aug;81(8):477-84. doi: 10.1111/j.1746-1561.2011.00617.x.
- BackgroundVirzi RA. Refining the Test Phase of Usability Evaluation: How Many Subjects Is Enough? Human Factors: The Journal of the Human Factors and Ergonomics Society. 1992; 1; 34(4): 457-68. https://2024.sci-hub.box/3857/2afb54700f6961ae637e388c3f96891c/virzi1992.pdf
- Background: PubMed 40412717Vargas-Martinez AM, Guillen-Martinez D, Domingo Perez T, Soilan Enriquez A, Zafra-Agea JA, Hoyos Cillero I, Lima-Serrano M, Tarrino-Concejero L. Analysis of the management function of the school nurse in Spain: use of records and interaction with primary care, the educational community and other institutions. Enferm Clin (Engl Ed). 2025 Sep-Oct;35(5):502200. doi: 10.1016/j.enfcle.2025.502200. Epub 2025 May 22.
- Background: PubMed 39972503Agyei FB, Kaura DK, Bell JD. Parent-adolescent sexual and reproductive health information communication in Ghana. Reprod Health. 2025 Feb 19;22(1):25. doi: 10.1186/s12978-025-01961-y.
- BackgroundMukanga B, Dlamini SB, Taylor M. Cultural appropriateness of a comprehensive sexuality education programme. Implications for programme adaptation and implementation in Zambia. Sex Educ. 2025; 3;25(5): 631-46. https://doi.org/10.1080/14681811.2024.2367761
- Background: PubMed 7633241Kitzinger J. Qualitative research. Introducing focus groups. BMJ. 1995 Jul 29;311(7000):299-302. doi: 10.1136/bmj.311.7000.299.
- Background: PubMed 17872937Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
- Background: PubMed 34253078Lee SD, Iott B, Banaszak-Holl J, Shih SF, Raj M, Johnson KE, Kiessling K, Moore-Petinak N. Application of Mixed Methods in Health Services Management Research: A Systematic Review. Med Care Res Rev. 2022 Jun;79(3):331-344. doi: 10.1177/10775587211030393. Epub 2021 Jul 12.
- BackgroundLeech N, Onwuegbuzie A. Guidelines for conducting and reporting mixed research in the field of counseling and beyond. Journal of Counseling and Development. 2010; 88(1): 61-9. doi: 10.1002/j.1556-6678.2010.tb00151.x
- BackgroundMuheriwa-Matemba S, Crooks N, Hall H et al. 156. Fostering Young Adolescent Engagement in Sexual Health Research: A Youth-Led Community-Based Participatory Research in Western NY. Journal of Adolescent Health. 2025; 76(3): S81. doi: 10.1016/j.jadohealth.2024.11.172
- Individual participant dataSharing planned: Yes. The project will generate qualitative data (focus groups with adolescents, parents, associations, public agencies, NGOs for the cultural adaptation of the IYG program) and quantitative data (usability and pilot tests with adolescents in Andalusia and Catalonia). Data, in text and table formats, will be stored in the DIGIBUG repository (Qualified Dublin Core metadata, unique identifier, version control). They will be accessible after processing, except those protected by personal data regulations, which will be embargoed. No raw or sociodemographic data will be published. Materials will have a Creative Commons license and may be reused after project completion, with up to 3 years embargo for doctoral theses. DIGIBUG will perform backups and ensure security. Data will be pseudonymized or anonymized (AMNESIA tool) and owned by the PI, who will ensure legal and ethical compliance.
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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.
Marta Lima Serrano, Full professor contact
Alba Sierra Yagüe, Phd Student principal investigator
Catalan Institute of Health
Marta Lima Serrano, Full professor study director
University of Seville
José Antonio Zafra Agea, PhD principal investigator
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Es tu juego: decide bien (IYG) in people with Sexual Behavior and Sexually Transmitted Disease (STD), run by University of Seville at 1 site 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alba Sierra Yagüe, PhD student. Nurse (652260353, Albbii.sy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants maintaining abstinence from oral, vaginal, and anal sex, assessed using a self-administered questionnaire adapted from It's Your Game: Keep It Real. (time frame: Baseline (Month 0), at the end of the first and second school year of implementation and the end of the following school year and end of follow-up (Month 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07208045, which also lists 27 linked publications.
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 8 Oct 2025.