search
Back to results

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

Primary Purpose

Sexually Transmitted Diseases, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Bacterial

Status
Terminated
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Psychoeducational intervention
Sponsored by
Rosa Jimenez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring sexual behavior, condom use, Self-Efficacy, educational technology

Eligibility Criteria

17 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Autonoma de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Psychoeducational intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Self-efficacy in the use of male condom
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.
Safe sexual behavior
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.

Secondary Outcome Measures

Satisfaction with the intervention
Measured with a Likert scale from very unsatisfied to very satisfied (only for the intervention group)

Full Information

First Posted
September 24, 2018
Last Updated
January 19, 2021
Sponsor
Rosa Jimenez
search

1. Study Identification

Unique Protocol Identification Number
NCT03684668
Brief Title
Psychoeduc Interv. Through Meta-universes on Condom's Use Self - Efficacy and Sexual Behavior in Students of UAChile
Acronym
MVSR
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Data collection could not be completed in time and it has not been possible to continue due to the pandemic. Since it is not yet known when the face-to-face classes will resume, we moved on to the data analysis phase with the existing data.
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rosa Jimenez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Bacterial
Keywords
sexual behavior, condom use, Self-Efficacy, educational technology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
All forms with the questionnaires will be consecutively numbered before the beginning of the study and randomly allocated to one of the study groups. This assignment list will be given to the secretary who will allocate the questionnaires to the corresponding group and deliver them to the corresponding researcher. After completion, all forms will be collected and merged and then delivered again to the secretary who will randomly assign number 1 or 2 to one of the groups and will write this number in the upper right edge of each completed questionnaire according to the original assignment list. The researcher that will introduce data in the database will include a field for this number but will not know to which of the groups it belongs. Statistical analysis will be then carried comparing groups 1 and 2. This will not be uncovered until all results are obtained and are ready for discussion.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducational intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-efficacy in the use of male condom
Description
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.
Time Frame
15 days
Title
Safe sexual behavior
Description
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.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Satisfaction with the intervention
Description
Measured with a Likert scale from very unsatisfied to very satisfied (only for the intervention group)
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Hernandez, PhD
Organizational Affiliation
Universidad Autonoma de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Autonoma de Chile
City
Santiago
State/Province
Region Metropolitana
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
24432923
Citation
Jemmott JB 3rd, Jemmott LS, O'Leary A, Ngwane Z, Icard LD, Heeren GA, Mtose X, Carty C. Cluster-randomized controlled trial of an HIV/sexually transmitted infection risk-reduction intervention for South African men. Am J Public Health. 2014 Mar;104(3):467-73. doi: 10.2105/AJPH.2013.301578. Epub 2014 Jan 16.
Results Reference
background
PubMed Identifier
28467158
Citation
Khumsaen N, Stephenson R. Beliefs and Perception About HIV/AIDS, Self-Efficacy, and HIV Sexual Risk Behaviors Among Young Thai Men Who Have Sex With Men. AIDS Educ Prev. 2017 Apr;29(2):175-190. doi: 10.1521/aeap.2017.29.2.175.
Results Reference
background
PubMed Identifier
26981840
Citation
Bermudez Mde L, Araujo LF, Reyes AO, Hernandez-Quero J, Teva I. Analysis of cognitive variables and sexual risk behaviors among infected and HIV-uninfected people from Spain. AIDS Care. 2016 Jul;28(7):890-7. doi: 10.1080/09540121.2016.1161163. Epub 2016 Mar 16.
Results Reference
background
PubMed Identifier
23732487
Citation
Fernandez AM, Celis-Atenas K, Cordova-Rubio N, Dufey M, Correa Varella MA, Benedetti Piccoli Ferreira JH. [Youth sexuality: behaviors, attitudes and differences by sex and personality variables in Chilean university students]. Rev Med Chil. 2013 Feb;141(2):160-6. doi: 10.4067/S0034-98872013000200003. Spanish.
Results Reference
background
PubMed Identifier
23110684
Citation
Gabarron E, Serrano JA, Wynn R, Armayones M. Avatars using computer/smartphone mediated communication and social networking in prevention of sexually transmitted diseases among North-Norwegian youngsters. BMC Med Inform Decis Mak. 2012 Oct 30;12:120. doi: 10.1186/1472-6947-12-120.
Results Reference
background
PubMed Identifier
24550130
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.
Results Reference
background
PubMed Identifier
24163112
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;(10):CD010662. doi: 10.1002/14651858.CD010662.pub2.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs