NCT04429672

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

June 7, 2020

Last Update Submit

June 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    six months

Secondary Outcomes (3)

  • attitudes and opinions towards the sexuality

    six months

  • risky sexual behaviors

    six months

  • knowledge and exercise of the sexual rights

    six months

Study Arms (2)

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.

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.

Behavioral: Friendly sexual health services and reproductive for adolescents

Interventions

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

Experimental Group (EG)

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

Control Group (CG)

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Young people who reported going to private family planning services.
  • They were in the gestation stage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern University Center

Zapotlán el Grande, Jalisco, 4900, Mexico

Location

Related Publications (1)

  • 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: 29267654BACKGROUND

MeSH Terms

Interventions

Reproductive Physiological Phenomena

Intervention Hierarchy (Ancestors)

Reproductive and Urinary Physiological Phenomena

Study Officials

  • Jonathan J Vazquez Perez, Msc

    University of Guadalajara

    PRINCIPAL INVESTIGATOR
  • Benjamin Trujillo Hernández, Dsc

    Universidad de Colima

    STUDY DIRECTOR
  • José C Vásquez Jiménez, Dsc

    Universidad de Colima

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 12, 2020

Study Start

September 9, 2019

Primary Completion

July 12, 2020

Study Completion

December 11, 2020

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations