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

NCT03684668 | Terminated

• 1 other identifier: SEXUALHEALTHRISKMETAVERSE
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

sexual behavior; condom use; Self-Efficacy; educational technology

Outcome Measures

Primary Outcomes (2)

• 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.

  15 days

• 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.

  15 days

Secondary Outcomes (1)

• Satisfaction with the intervention

  one day

Study Arms (2)

Psychoeducational intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Psychoeducational intervention BEHAVIORAL

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.

Psychoeducational intervention

Eligibility Criteria

• Age: 17 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Nursing students
• Medicine students

Sponsors & Collaborators

• Rosa Jimenez: lead

Study Sites (1)

Universidad Autonoma de Chile

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (7)

• 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.

  PMID: 24432923 BACKGROUND

• 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.

  PMID: 28467158 BACKGROUND

• 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.

  PMID: 26981840 BACKGROUND

• 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.

  PMID: 23732487 BACKGROUND

• 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.

  PMID: 23110684 BACKGROUND

• 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.

  PMID: 24550130 BACKGROUND

• 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.

  PMID: 24163112 BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases, Bacterial; Sexual Behavior

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Virus Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Behavior

Study Officials

• Abdul Hernandez, PhD

  Universidad Autonoma de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 26, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 28, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within one year of the study completion.
• Access Criteria: Data access will be released for those who request them after the publication of the study.

Locations

CL (1)