Clinical trial NCT05896540: Randomized Controlled Trial of a Gender-transformative School-based Sexual Health Intervention
Official title: Study Protocol: a Randomized Controlled Trial of a Gender-transformative School-based Sexual Health Intervention in Chilean Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sexuality
Keywords: School-based sexual health intervention
Gender perspective
School intervention
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: National Fund for Research and Development in Health, Chile
First posted: 2023-06-09
Enrollment: 609
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The assignment of the participants to the groups will be implemented in a two-stage selection of the students; since there are already existing teaching-learning processes in process in the schools, with their time limitations, the investigators will have to choose entire "courses" (in Chilean secondary schools, a course is a group of about 40 students who have all classes together) rather than choose individual students. The investigators will establish groups among the schools to compensate for their different sizes; some schools in the commune are much larger than the others (four or more courses per grade. Thus the investigators will divide the schools into two blocks; one with the largest schools and one with the medium- and small-sized schools. In the second stage, courses that meet the inclusion criteria to participate in the study will be selected randomly within each of the blocks. Table 1 details the distribution of the samples.
Primary purpose: PREVENTION

Brief summary: 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in knowledge of sexuality
timeFrame: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
measure: Change in preventive sexual behavior
timeFrame: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
measure: Change in gender actitude
timeFrame: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
measure: Change in gender actitude
timeFrame: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
measure: Change in gender actitude
timeFrame: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
measure: Change in components of mental health related to sexual health
timeFrame: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
measure: Change in components of mental health related to sexual health
timeFrame: One-week pre-intervention, immediately post-intervention and a 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Chile
name: Loreto Leiva, PhD
role: PRINCIPAL_INVESTIGATOR
References: