Randomized Controlled Trial of a Gender-transformative School-based Sexual Health Intervention (ENFOCATE)

University of Chile

Status: Not yet enrolling

Conditions: Sexuality

Treatments: Behavioral: ENFOCATE

Study type: Interventional

Funder types: Other

Identifiers

NCT05896540

FONIS SA21I0142

Details and patient eligibility

About

The goal of this randomized controlled trial (RCT) is to evaluate the effectiveness of a comprehensive gender-transformative intervention of sexual education (ENFOCATE -Focus-on) in adolescents, using a mixed experimental design. The intervention will be directed exclusively to students of the 10th and 11th grades who are enrolled in one of the education establishments that depend on the Municipality of Santiago. The randomization will be by grade, and the data will be collected at three moments (pre-intervention, post-intervention and a 3-month follow-up).

Full description

The investigators propose a mixed experimental design with a randomized controlled trial (RCT) that will evaluate the efficiency of an intervention and implementation of a comprehensive gender-transformative sexual education, along with qualitative studies to understand the implementation process. The results of the intervention will be evaluated after it finishes, and in a three-month follow-up. Each participant will be sent a link to the questionnaire (web-based survey). Follow-up contact will be done with WhatsApp or telephone calls.

The hypothesis is that the intervention designed and implemented in the experimental group: (1) will increase their sexuality knowledge level; (2) will increase their preventive sexual behavior (or intentions); (3) will favor a gender-positive attitude; and (4) will decrease internalizing and externalizing problems in mental health. The secondary objective is to examine the implementation intervention process, that is, identify the strengths and obstacles in the real context in which the study intervention is performed, to understand the determinants and strategies of the success of the implementation.

Enrollment: 609 estimated patients

Sex: All

Ages: 14 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Schools with students of the 10th and 11th grades who are enrolled in one of the education establishments that depend on the Municipality of Santiago.
• Schools not being an education center oriented to adults or persons deprived of liberty (e.g. closed or semi-closed compounds of Gendarmería de Chile or the National Service for Minors)
• Schools with regularity in teaching and learning (for example, schools that were not partially interrupted in 2022 by student manifestations)
• Schools with informed consent of the director.
• Students having 90% or greater attendance in classes
• Students providing informed consent of voluntary participation
• Students having explicit and informed consent of their parents or guardians.

Exclusion Criteria:

• Schools being an education center oriented to adults or persons deprived of liberty
• Schools without informed consent of the director
• Students without class attendance
• Students without informed consent of voluntary participation
• Students without an explicit and informed consent of their parents or guardians

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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609 participants in 2 patient groups

STUDY GROUP ENFOCATE

Experimental group

Description:

The selected students will be randomly divided into the study and control groups; the intervention will take place in the same schools that the students attend. The assignment to groups will use simple random sampling, performed in two stages. In the first stage the available schools will be randomly assigned to the study and control groups, while the second stage will select randomly the groups in each school that will participate in the study. The study groups will receive a 10-session intervention in sexual education, covering topics related to preventive sexual conduct, gender equity and mental health.

Treatment:

Behavioral: ENFOCATE

CONTROL GROUP

No Intervention group

Description:

The control groups will not receive intervention; they will continue with the sexual orientation that each school provides to its students.