Sexual HealthNCT04429672
Effect of a Socio-educational Intervention on Sexual Health in Young University Students
A study testing The Right to your Sexual Health and Friendly sexual health services and reproductive for adolescents in people with Sexual Health, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The sexual health is considered as a state of physical, mental and social well-being in relation to sexuality that requires a positive and respectful approach to sexuality, as well as the possibility of having pleasant and safe sexual experiences, free from all coercion, discrimination and violence. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Health
- What is being tested?
- The Right to your Sexual Health and Friendly sexual health services and reproductive for adolescents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 9 Sep 2019to 11 Dec 2020
- 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young college students aged 18 to 24.
- Que reported having an active sex life.
- Who attended the family planning counseling services of the School Clinic.
- Who agreed to participate in the study by signing informed consent.
Who cannot join
- Young people who reported going to private family planning services.
- They were in the gestation stage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Socio-educational Intervention on Sexual Health in Young University Students: Randomized Clinical Trial
The sexual health is considered as a state of physical, mental and social well-being in relation to sexuality that requires a positive and respectful approach to sexuality, as well as the possibility of having pleasant and safe sexual experiences, free from all coercion, discrimination and violence. However, lack of family planning, having unprotected sex, unwanted pregnancies, abortions, Sexually Transmitted Infections, lack of acceptance of sexual identity, sexism, having multiple sexual partners and having sex under the influence of alcohol and drugs are some of the main elements that alter the well-being of people's sexual health, especially in the young population. In this sense, different organizations have pointed out the importance of promoting in young people strategies related to providing an adequate level of knowledge in sexual health from a perspective of the exercise of sexual rights to reduce alterations in risky sexual practices and it has been identified that the school environment can be the ideal space for a health services approach to this age group to strengthen their well-being and ensure their development during adulthood. However, the sexual health interventions traditionally implemented by the health services are usually aimed mainly at transmitting knowledge about the benefits of condom use, sexually transmitted diseases and unwanted pregnancies and violence, excluding other elements that make up the sexual health and making use of conventional educational strategies through print media or short educational sessions, which causes little interaction between health personnel and users that consolidates the purpose of the interventions. That said, the implementation of a socio-educational intervention in sexual health that promotes sexual rights, positive attitudes towards sexuality and the prevention of risky sexual behaviors articulated in a model of a life project that motivates them to achieve the ideal stage of life for starting a family in a healthy way through family planning, can promote the strengthening not only of their sexual health but also their well-being for their future development as adults.
- Conditions
- Sexual Health
- Being tested
- The Right to your Sexual Health, Friendly sexual health services and reproductive for adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Right to your Sexual HealthBehavioural
which is of a socio-educational type and is made up of five thematic axes; Sexual Rights, Sexuality, Reproductive Health, Sexual Behavior and Life Project divided into ten sessions (two weekly) of 30 minutes each, each session has a structure of opening, development and closing phase
Friendly sexual health services and reproductive for adolescentsBehavioural
consists of six sessions (one a week) lasting 50 minutes each, using illustrative material through official flipcharts of the secretary of health on reproductive health, sexually transmitted diseases and sexual violence
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) | Experimental | The participants of the Experimental Group receive as treatment the intervention called "The Right to your Sexual Health", which is socio-educational and is composed of five thematic axes; Sexual Rights, Sexuality, Reproductive Health, Sexual Conduct and Life Project divided into ten sessions (two weekly) of 30 minutes each, each session has a structure of the opening, development and closing phase established in a manual for the facilitator, it should be noted that the intervention is applied by a multidisciplinary team in which the areas of medicine, nursing and psychology participate. In addition, Information and Communication Technologies (ICTs) are used through a Moodle platform that has available to participants digital support material as digital presentations on each of the thematic axes, as well as audiovisual material through the Podcast format of conversations concerning each of the axes. Receives: Behavioral: The Right to your Sexual Health |
| Control Group (CG) | Active comparator | The participants of the Control Group receive the usual sexual health intervention applied by Secretary of Health consisting of six sessions (one a week) lasting 50 minutes each using illustrative material through rotating official secretary of health folios on reproductive health, sexually transmitted diseases and sexual violence. Receives: Behavioral: Friendly sexual health services and reproductive for adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual health
Changes in the sexual health well-being of young college students. Measuring dimension changes from poor sexual health to good sexual health before and after the intervention, will be measured through proportions and the MacNemar test.
Measured: six months
Secondary outcomes (3)
attitudes and opinions towards the sexuality
Changes in the type of attitudes and opinions towards the sexuality of young university students. Measuring changes in scores obtained from the applicable auto instruments before and after the intervention, is meditated through medians and the Mann-Whitney test.
Measured: six months
risky sexual behaviors
Changes in the type of risky sexual behaviors of young college students. Measuring changes in scores obtained from the applicable auto instruments before and after the intervention, is meditated through medians and the Mann-Whitney test
Measured: six months
knowledge and exercise of the sexual rights
Changes in the knowledge and exercise of the sexual rights of young university students. Measuring changes in scores obtained from the applicable auto instruments before and after the intervention, it is meditated through medians and the Mann-Whitney test.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start9 Sep 2019
- Primary completion12 Jul 2020 (estimated)
- Study completion11 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual HealthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a socio-educational intervention and is composed of five thematic axes; Sexual Rights, Sexuality, Reproductive Health, Sexual Conduct and Life Project divided into ten sessions (two weekly) of 30 minutes each, each session has an established opening, development and closing phase structure
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Colima
- Responsible party
- Principal investigator, Jonathan Josue Vazquez Perez, University of Guadalajara
- Investigators
- Jonathan J Vazquez Perez, Msc, Principal investigator, University of GuadalajaraBenjamin Trujillo Hernández, Dsc, Study director, Universidad de ColimaJosé C Vásquez Jiménez, Dsc, Study director, Universidad de Colima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429672
- Sponsor's protocol ID
- VPJJ0001
- Status last verified
- Jun 2020
- First submitted
- 7 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villalobos A, Castro F, Rojas R, Allen B. [Contraception in Mexican adolescents in upper secondary schools: use and unmet needs]. Salud Publica Mex. 2017 Sep-Oct;59(5):566-576. doi: 10.21149/8481. Spanish.
PubMed 29267654
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Socio-educational Intervention on Sexual Health in Young University Students: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04429672
- Acronym / sponsor ID
- VPJJ0001
- Conditions
- Sexual Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Universidad de Colima
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 12 Jul 2020 (estimated)
- Study completion
- 11 Dec 2020 (estimated)
- First posted
- 12 Jun 2020 (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 sexual health is considered as a state of physical, mental and social well-being in relation to sexuality that requires a positive and respectful approach to sexuality, as well as the possibility of having pleasant and safe sexual experiences, free from all coercion, discrimination and violence. However, lack of family planning, having unprotected sex, unwanted pregnancies, abortions, Sexually Transmitted Infections, lack of acceptance of sexual identity, sexism, having multiple sexual partners and having sex under the influence of alcohol and drugs are some of the main elements that alter the well-being of people's sexual health, especially in the young population. In this sense, different organizations have pointed out the importance of promoting in young people strategies related to providing an adequate level of knowledge in sexual health from a perspective of the exercise of sexual rights to reduce alterations in risky sexual practices and it has been identified that the school environment can be the ideal space for a health services approach to this age group to strengthen their well-being and ensure their development during adulthood. However, the sexual health interventions traditionally implemented by the health services are usually aimed mainly at transmitting knowledge about the benefits of condom use, sexually transmitted diseases and unwanted pregnancies and violence, excluding other elements that make up the sexual health and making use of conventional educational strategies through print media or short educational sessions, which causes little interaction between health personnel and users that consolidates the purpose of the interventions. That said, the implementation of a socio-educational intervention in sexual health that promotes sexual rights, positive attitudes towards sexuality and the prevention of risky sexual behaviors articulated in a model of a life project that motivates them to achieve the ideal stage of life for starting a family in a healthy way through family planning, can promote the strengthening not only of their sexual health but also their well-being for their future development as adults.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It is a socio-educational intervention and is composed of five thematic axes; Sexual Rights, Sexuality, Reproductive Health, Sexual Conduct and Life Project divided into ten sessions (two weekly) of 30 minutes each, each session has an established opening, development and closing phase structure
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Behavioral: The Right to your Sexual HealthThe participants of the Experimental Group receive as treatment the intervention called "The Right to your Sexual Health", which is socio-educational and is composed of five thematic axes; Sexual Rights, Sexuality, Reproductive Health, Sexual Conduct and Life Project divided into ten sessions (two weekly) of 30 minutes each, each session has a structure of the opening, development and closing phase established in a manual for the facilitator, it should be noted that the intervention is applied by a multidisciplinary team in which the areas of medicine, nursing and psychology participate. In addition, Information and Communication Technologies (ICTs) are used through a Moodle platform that has available to participants digital support material as digital presentations on each of the thematic axes, as well as audiovisual material through the Podcast format of conversations concerning each of the axes. |
| Control Group (CG) | Active comparator | Behavioral: Friendly sexual health services and reproductive for adolescentsThe participants of the Control Group receive the usual sexual health intervention applied by Secretary of Health consisting of six sessions (one a week) lasting 50 minutes each using illustrative material through rotating official secretary of health folios on reproductive health, sexually transmitted diseases and sexual violence. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Young college students aged 18 to 24.
- Que reported having an active sex life.
- Who attended the family planning counseling services of the School Clinic.
- Who agreed to participate in the study by signing informed consent.
Key exclusion criteria (2 listed)
- Young people who reported going to private family planning services.
- They were in the gestation stage.
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 |
|---|---|---|
| The Right to your Sexual Healthwhich is of a socio-educational type and is made up of five thematic axes; Sexual Rights, Sexuality, Reproductive Health, Sexual Behavior and Life Project divided into ten sessions (two weekly) of 30 minutes each, each session has a structure of opening, development and closing phase | Behavioural | Experimental Group (EG) |
| Friendly sexual health services and reproductive for adolescentsconsists of six sessions (one a week) lasting 50 minutes each, using illustrative material through official flipcharts of the secretary of health on reproductive health, sexually transmitted diseases and sexual violence | Behavioural | Control Group (CG) |
Primary outcome
sexual health
Time frame: six months
Changes in the sexual health well-being of young college students. Measuring dimension changes from poor sexual health to good sexual health before and after the intervention, will be measured through proportions and the MacNemar test.
3 secondary outcomes
attitudes and opinions towards the sexuality
Time frame: six months
risky sexual behaviors
Time frame: six months
knowledge and exercise of the sexual rights
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Background: PubMed 29267654Villalobos A, Castro F, Rojas R, Allen B. [Contraception in Mexican adolescents in upper secondary schools: use and unmet needs]. Salud Publica Mex. 2017 Sep-Oct;59(5):566-576. doi: 10.21149/8481. Spanish.
- 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.
Jonathan J Vazquez Perez, Msc principal investigator
University of Guadalajara
Benjamin Trujillo Hernández, Dsc study director
Universidad de Colima
José C Vásquez Jiménez, Dsc study director
Universidad de Colima
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Right to your Sexual Health and Friendly sexual health services and reproductive for adolescents in people with Sexual Health, run by University of Guadalajara at 1 site in Mexico.
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 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: status not confirmed, as of the sponsor's last update on 17 Jun 2020. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexual health (time frame: six months). 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 NCT04429672, which also lists 1 linked publication.
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 17 Jun 2020.