- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04429672
Effect of a Socio-educational Intervention on Sexual Health in Young University Students
June 15, 2020 updated by: Jonathan Josue Vazquez Perez, University of Guadalajara
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jalisco
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Zapotlan el grande, Jalisco, Mexico, 4900
- Southern University Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria;
- 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.
Exclusion criteria;
- Young people who reported going to private family planning services.
- They were in the gestation stage.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Group (EG)
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.
|
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
|
ACTIVE_COMPARATOR: Control Group (CG)
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.
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
attitudes and opinions towards the sexuality
Time Frame: six months
|
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.
|
six months
|
risky sexual behaviors
Time Frame: six months
|
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
|
six months
|
knowledge and exercise of the sexual rights
Time Frame: six months
|
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.
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan J Vazquez Perez, Msc, University of Guadalajara
- Study Director: Benjamin Trujillo Hernández, Dsc, Universidad de Colima
- Study Director: José C Vásquez Jiménez, Dsc, Universidad de Colima
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 9, 2019
Primary Completion (ANTICIPATED)
July 12, 2020
Study Completion (ANTICIPATED)
December 11, 2020
Study Registration Dates
First Submitted
June 7, 2020
First Submitted That Met QC Criteria
June 9, 2020
First Posted (ACTUAL)
June 12, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 17, 2020
Last Update Submitted That Met QC Criteria
June 15, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- VPJJ0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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