Clinical trial NCT03684668: Psychoeduc Interv. Through Meta-universes on Condom's Use Self - Efficacy and Sexual Behavior in Students of UAChile
Official title: Psychoeducational Intervention Through Meta - Universes on Self - Efficacy in the Use of Condoms and Sexual Behavior in University Students of the Autonomous University of Chile, 2018.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases, Bacterial
Keywords: sexual behavior
condom use
Self-Efficacy
educational technology
Lead sponsor: Universidad Autónoma de Chile
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 90
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a behavioral intervention where 120 university students will be randomly assigned to the intervention or de control group. Intervention consists in a psychoeducational activity enhanced using meta-universes or three-dimensional virtual worlds. Each selected student will undergo a three-session educational activity before a personal computer and wearing 3D lenses. The first session is called "Knowledge about STI"; the second session is entitled "Use of the male condom" and the third session is called "Talking about sexuality issues". The intervention will be carried out every 24 hours with four participants in four computers and 3D lenses available in the computer labs of the University. The control group will not receive this intervention.
Primary purpose: PREVENTION

Brief summary: In Chile, sexually transmitted infections (STI)s, including HIV / AIDS, are the main causes of morbidity in adolescents and young adults. The surveillance bulletin of the Institute of Public Health revealed an increase in cases of gonorrhea, over 200% in the last five years. HIV cases increased between 34% and 47% in this period as well.

Unsafe sexual behaviors are among the most important risk factors for sexually transmitted infections (STI); it has been shown that educational / behavioral interventions can achieve success in behavioral changes, especially in young people. Some studies have evaluated the effectiveness of behavioral interventions to prevent sexual risk behavior of HIV and STIs with encouraging results.

On the other hand, information and communication technologies (ICT) have been used in the prevention of STIs, HIV / AIDS. There is a considerable increase in the use of meta-universes or three-dimensional virtual worlds for educational purposes since 2006. No studies have yet been found that demonstrate the effectiveness of educational interventions carried out in meta-universes for the prevention of STIs in Chile.

This study aims to demonstrate the effectiveness of a psychoeducational intervention through the use of meta-universes, on self-efficacy in the use of condoms and safe sexual behavior, in university students.

An open randomized, controlled trial will be conducted. Dependent variables will be measured before the intervention and 15 days after the end of the intervention in the experimental group in both groups.

Students from first year to fourth year of different careers (except Nursing), currently in the Universidad Autonoma de Chile will be included after their informed consent.

The psychoeducational intervention consists of three sessions in which techniques based on three of the four sources of self-efficacy described are applied.

The intervention will be carried out every 24 hours with four participants in four computers and 3D lenses available in the computer labs of the University.

The dependent variables will be: 1) the self-efficacy in the use of male condom, measured with the Scale Condom self-efficacy scale of Brafford and Beck and 2) safe sexual behavior measured with Safe Sex Behavior Questionnaire scale of Dilorio, Lehr, Adame and Carlone. Both scales were culturally adapted to Chile.

Detailed description: In Chile, sexually transmitted infections (STI)s, including HIV / AIDS, are the main causes of morbidity in adolescents and young adults. The surveillance bulletin of the Institute of Public Health revealed an increase in cases of gonorrhea, over 200% in the last five years. HIV cases increased between 34% and 47% in this period as well.

Unsafe sexual behaviors are among the most important risk factors for these diseases; it has been shown that educational / behavioral interventions can achieve success in behavioral changes, especially in young people. Some studies have evaluated the effectiveness of behavioral interventions to prevent sexual risk behavior of HIV and STIs with encouraging results.

On the other hand, information and communication technologies (ICT) have been used in the prevention of STIs, HIV / AIDS. These include computer interventions through meta-universes, chat rooms, text messaging and social media. There is a considerable increase in the use of meta-universes or three-dimensional virtual worlds for educational purposes since 2006. No studies have yet been found that demonstrate the effectiveness of educational interventions carried out in meta-universes for the prevention of STIs in Chile.

This study aims to demonstrate the effectiveness of a psychoeducational intervention through the use of meta-universes, on self-efficacy in the use of condoms and safe sexual behavior, in university students.

An open randomized, controlled trial will be conducted. Dependent variables will be measured before the intervention and 15 days after the end of the intervention in the experimental group, in both groups.

Students from first year to fourth year of different careers (except Nursing), currently in the Universidad Autonoma de Chile will be included after their informed consent.

The psychoeducational intervention consists of three sessions in which techniques based on three of the four sources of self-efficacy described are applied. The first session is called "Knowledge about STI"; the second session is entitled "Use of the male condom" and the third session is called "Talking about sexuality issues". In the first session screens will be created with interactive information in which the participants wearing 3D glasses will select information on different types of STIs; modeled situations will be presented in which students will perform and at the same time develop self-efficacy in terms of knowledge about STIs. In the second session four metaverses will be created, the first represents a modeled situation in which the participant selects an avatar, then selects a scenario between four risk situations where he meets a possible sexual partner. The student must select riddles that lead to responsible sexual behavior, selecting the best way to use the condom and different barrier methods, proposing its use and rejecting any risky behavior. In the third session, four meta-universes will be created through 3D technology, each participant selects an avatar and a different role is assigned to each one so that they generate sexuality communication skills among them without knowing each one's identity.

The intervention will be carried out every 24 hours with four participants in four computers and 3D lenses available in the computer labs of the University.

The dependent variables will be: 1) the self-efficacy in the use of male condom, measured with the Scale Condom self-efficacy scale of Brafford and Beck and 2) safe sexual behavior measured with Safe Sex Behavior Questionnaire scale of Dilorio, Lehr, Adame and Carlone. Both scales were culturally adapted to Chile.

Eligibility criteria: Inclusion Criteria:

* University students registered in the campus El Llano of the Universidad Autonoma de Chile.
* Students from first to fourth year.

Exclusion Criteria:

* Nursing students
* Medicine students

Primary outcomes:
measure: Self-efficacy in the use of male condom
timeFrame: 15 days
measure: Safe sexual behavior
timeFrame: 15 days
Secondary outcomes:
measure: Satisfaction with the intervention
timeFrame: one day
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad Autonoma de Chile
state: Region Metropolitana
Study officials:
affiliation: Universidad Autonoma de Chile
name: Abdul Hernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ghanbarzadeh R, Ghapanchi AH, Blumenstein M, Talaei-Khoei A. A decade of research on the use of three-dimensional virtual worlds in health care: a systematic literature review. J Med Internet Res. 2014 Feb 18;16(2):e47. doi: 10.2196/jmir.3097.
citation: Lopez LM, Otterness C, Chen M, Steiner M, Gallo MF. Behavioral interventions for improving condom use for dual protection. Cochrane Database Syst Rev. 2013 Oct 26;2013(10):CD010662. doi: 10.1002/14651858.CD010662.pub2.