<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04429672</url>
  </required_header>
  <id_info>
    <org_study_id>VPJJ0001</org_study_id>
    <nct_id>NCT04429672</nct_id>
  </id_info>
  <brief_title>Effect of a Socio-educational Intervention on Sexual Health in Young University Students</brief_title>
  <official_title>Effect of a Socio-educational Intervention on Sexual Health in Young University Students: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Guadalajara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad de Colima</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Guadalajara</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The sexual health is considered as a state of physical, mental and social well-being in&#xD;
      relation to sexuality that requires a positive and respectful approach to sexuality, as well&#xD;
      as the possibility of having pleasant and safe sexual experiences, free from all coercion,&#xD;
      discrimination and violence. However, lack of family planning, having unprotected sex,&#xD;
      unwanted pregnancies, abortions, Sexually Transmitted Infections, lack of acceptance of&#xD;
      sexual identity, sexism, having multiple sexual partners and having sex under the influence&#xD;
      of alcohol and drugs are some of the main elements that alter the well-being of people's&#xD;
      sexual health, especially in the young population. In this sense, different organizations&#xD;
      have pointed out the importance of promoting in young people strategies related to providing&#xD;
      an adequate level of knowledge in sexual health from a perspective of the exercise of sexual&#xD;
      rights to reduce alterations in risky sexual practices and it has been identified that the&#xD;
      school environment can be the ideal space for a health services approach to this age group to&#xD;
      strengthen their well-being and ensure their development during adulthood. However, the&#xD;
      sexual health interventions traditionally implemented by the health services are usually&#xD;
      aimed mainly at transmitting knowledge about the benefits of condom use, sexually transmitted&#xD;
      diseases and unwanted pregnancies and violence, excluding other elements that make up the&#xD;
      sexual health and making use of conventional educational strategies through print media or&#xD;
      short educational sessions, which causes little interaction between health personnel and&#xD;
      users that consolidates the purpose of the interventions. That said, the implementation of a&#xD;
      socio-educational intervention in sexual health that promotes sexual rights, positive&#xD;
      attitudes towards sexuality and the prevention of risky sexual behaviors articulated in a&#xD;
      model of a life project that motivates them to achieve the ideal stage of life for starting a&#xD;
      family in a healthy way through family planning, can promote the strengthening not only of&#xD;
      their sexual health but also their well-being for their future development as adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 9, 2019</start_date>
  <completion_date type="Anticipated">December 11, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 12, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>For the formation of the groups, a restrictive randomization was performed by fixed proportion considering the sample size required for the groups, in which the participant did not identify which group was assigned (simple blind)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>sexual health</measure>
    <time_frame>six months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>attitudes and opinions towards the sexuality</measure>
    <time_frame>six months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>risky sexual behaviors</measure>
    <time_frame>six months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>knowledge and exercise of the sexual rights</measure>
    <time_frame>six months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Sexual Health</condition>
  <arm_group>
    <arm_group_label>Experimental Group (EG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants of the Experimental Group receive as treatment the intervention called &quot;The Right to your Sexual Health&quot;, 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (CG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Right to your Sexual Health</intervention_name>
    <description>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</description>
    <arm_group_label>Experimental Group (EG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Friendly sexual health services and reproductive for adolescents</intervention_name>
    <description>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</description>
    <arm_group_label>Control Group (CG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria;&#xD;
&#xD;
          -  Young college students aged 18 to 24.&#xD;
&#xD;
          -  Que reported having an active sex life.&#xD;
&#xD;
          -  Who attended the family planning counseling services of the School Clinic.&#xD;
&#xD;
          -  Who agreed to participate in the study by signing informed consent.&#xD;
&#xD;
        Exclusion criteria;&#xD;
&#xD;
          -  Young people who reported going to private family planning services.&#xD;
&#xD;
          -  They were in the gestation stage.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan J Vazquez Perez, Msc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Guadalajara</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Benjamin Trujillo Hernández, Dsc</last_name>
    <role>Study Director</role>
    <affiliation>Universidad de Colima</affiliation>
  </overall_official>
  <overall_official>
    <last_name>José C Vásquez Jiménez, Dsc</last_name>
    <role>Study Director</role>
    <affiliation>Universidad de Colima</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southern University Center</name>
      <address>
        <city>Zapotlan el grande</city>
        <state>Jalisco</state>
        <zip>4900</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>29267654</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Guadalajara</investigator_affiliation>
    <investigator_full_name>Jonathan Josue Vazquez Perez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04429672
org study id: VPJJ0001
nct id: NCT04429672
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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
primary purpose: Supportive Care
masking: Single (Participant)
masking description: For the formation of the groups, a restrictive randomization was performed by fixed proportion considering the sample size required for the groups, in which the participant did not identify which group was assigned (simple blind)
measure: sexual health
time frame: six months
description: 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.
measure: attitudes and opinions towards the sexuality
time frame: six months
description: 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.
measure: risky sexual behaviors
time frame: six months
description: 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
measure: knowledge and exercise of the sexual rights
time frame: six months
description: 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.
arm group label: Experimental Group (EG)
arm group type: Experimental
description: 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.
arm group label: Control Group (CG)
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: The Right to your Sexual Health
description: 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
arm group label: Experimental Group (EG)
intervention type: Behavioral
intervention name: Friendly sexual health services and reproductive for adolescents
description: 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
arm group label: Control Group (CG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan J Vazquez Perez, Msc
role: Principal Investigator
affiliation: University of Guadalajara
last name: Benjamin Trujillo Hernández, Dsc
role: Study Director
affiliation: Universidad de Colima
last name: José C Vásquez Jiménez, Dsc
role: Study Director
affiliation: Universidad de Colima
facility: 
country: Mexico
citation: 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.
PMID: 29267654
responsible party type: Principal Investigator
investigator affiliation: University of Guadalajara
investigator full name: Jonathan Josue Vazquez Perez
investigator title: Principal Investigator
sharing ipd: No