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Sexually Transmitted DiseasesMVSRNCT03684668

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

A study testing Psychoeducational intervention in people with Sexually Transmitted Diseases and Sexually Transmitted Diseases, Viral, run by Rosa Jimenez at 1 site in Chile.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 to 30 years
What is being tested?
Psychoeducational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChile
Study dates
1 Oct 2018to 28 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • Nursing students
  • Medicine students

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Universidad Autonoma de Chile

    Santiago, Santiago Metropolitan

Other trials in Chile

About this study

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.

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.

Read more

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.

Read the 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.

Being tested
Psychoeducational intervention
Keywords
sexual behavior, condom use, Self-Efficacy, educational technology
Medical subject headings
Sexually Transmitted Diseases, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Bacterial, Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychoeducational interventionBehavioural

    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.

Study groups in NCT03684668
Study groupRoleWhat they receive
Psychoeducational interventionExperimentalThe 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.
Receives: Behavioral: Psychoeducational intervention
ControlNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 15 days

  2. 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.

    Measured: 15 days

Secondary outcomes (1)
  1. Satisfaction with the intervention

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

    Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2018
  2. Study start1 Oct 2018
  3. Primary completion31 Dec 2019
  4. Study completion28 Mar 2020

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03684668
Sponsor's protocol ID
SEXUALHEALTHRISKMETAVERSE
Acronym
MVSR
Status last verified
Jan 2021
First submitted
24 Sep 2018
Last updated
22 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (IPD) that underlie results in a publication.

Publications

  • 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.

    PubMed 24432923
  • 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.

    PubMed 28467158
  • 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.

    PubMed 26981840
  • 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.

    PubMed 23732487
  • 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.

    PubMed 23110684
  • 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.

    PubMed 24550130
  • 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.

    PubMed 24163112

Questions about this trial

What is this clinical trial studying?

A study testing Psychoeducational intervention in people with Sexually Transmitted Diseases and Sexually Transmitted Diseases, Viral, run by Rosa Jimenez at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-efficacy in the use of male condom (time frame: 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03684668, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.

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