Psychoeduc Interv. Through Meta-universes on Condom's Use Self - Efficacy and Sexual Behavior in Students of UAChile (MVSR)

January 19, 2021 updated by: Rosa Jimenez

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile
        • Universidad Autónoma de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Psychoeducational intervention
The psychoeducational intervention, with the use of meta-universes,consists of three sessions in which techniques based on three of the four sources of self-efficacy described are applied.
Behavioral: Psychoeducational intervention
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.
NO_INTERVENTION: Control
The control arm will not receive the psychoeducational intervention. Students in this group will complete the questionnaires before the beginning of the intervention and after its end.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy in the use of male condom
Time Frame: 15 days
Self-efficacy in the use of male condom measured with an adaptation of the Condom Use Self Efficacy Scale (CUSES) developed by Brafford and Beck in 1991. This scale consists of 21 items describing an individual's feelings of confidence about being able to buy condoms, put them on and take them off, and negotiate their use with a new sexual partner. Each item is answered with a five-point Likert scale (0: total disagreement to 4: total agreement). Six items are worded negatively so should be reversed when coding. Total scores go from 0 to 84 points, the higher the better self-efficacy. This scale underwent translation and cross-cultural adaptation in Cuba (http://dx.doi.org/10.4321/S1132-12962011000200012) and is now in a process of cross-cultural validation in Chile (Universidad Autonoma de Chile) before the beginning of the study. The original authors of the scale have been consulted and agree with adaptation and validation.
15 days
Safe sexual behavior
Time Frame: 15 days
Safe sexual behavior measured with an adaptation of the Safe Sex Behavior Questionnaire (SSBQ) first developed by DiIorio, Parsons, Lehr, Adame and Carlone in 1992. This scale aims to detect safe sexual practices and risky sexual behavior. The current scale has 23 items. Participants rate on a 4-point scale the degree of safe sex practices from "never" (recorded as 1) to "always" (recorded as 4). There are 8 items worded negatively that should be reversed when coding. The total possible range of scores in this adapted SSBQ is between 23 and 92, with higher scores indicating less risky sexual behavior and lower scores indicating more risky sexual behavior. This scale is undergoing translation and cross-cultural validation now in Chile (Universidad Autonoma de Chile). The original authors of the scale have been consulted and agree with adaptation and validation.
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with the intervention
Time Frame: one day
Measured with a Likert scale from very unsatisfied to very satisfied (only for the intervention group)
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rosa Jimenez

Investigators

  • Principal Investigator: Abdul Hernandez, PhD, Universidad Autónoma de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2018

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

March 28, 2020

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (ACTUAL)

September 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEXUALHEALTHRISKMETAVERSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data (IPD) that underlie results in a publication.

IPD Sharing Time Frame

Data will be available within one year of the study completion.

IPD Sharing Access Criteria

Data access will be released for those who request them after the publication of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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