NCT02686736

Brief Summary

The objective of this study is to design and evaluate an internet-based educational strategy to prevent sexual risk behaviors in Mexican adolescents. Methods: A field trial with one intervention and one comparison group, with ex-ante and ex-post measurements will be conducted in 2 public secondary schools. Adolescents between 14 and 15 years of age will participate. The intervention will be conducted in one school and the other school will serve as a comparison group, where investigators will observe the usual sexual education that the school provides. The intervention will be delivered through an internet web page; it includes four educational sessions that will be provided during a four-week period. The follow up will last three-months. The information on the study variables will be obtained through an internet-based self-applied questionnaire and collected on three occasions: when the adolescents enters to the study (baseline), once intervention is completed (at one month) and after three months of follow-up (at fourth month).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

February 11, 2016

Last Update Submit

January 30, 2017

Conditions

Keywords

internet-based educational interventionrisky sexual behaviorsprevention

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in attitudes regarding condom use at 1 and 4 months measured by the University of California, Los Angeles Multidimensional Condom Attitudes Scale

    Attitudes regarding condom use will be measured by the University of California, Los Angeles Multidimensional Condom Attitudes Scale.

    Baseline, 1 month, and 4 months

Secondary Outcomes (2)

  • Change from baseline in knowledge of sexually transmitted infections at 1 and 4 months measured by the scale validated in Mexican teens by Robles-Montijo and Diaz-Loving

    Baseline, 1 month, and 4 months

  • Change from baseline in self-efficacy toward consistent condom use at 1 and 4 months assessed by the seven measures proposed by Fishbein and colleagues

    Baseline, 1 month, and 4 months

Study Arms (2)

Internet-based educational intervention

OTHER

The Internet-based educational intervention will include four educational sessions that will be provided during a four-week period. The follow up will last three-months.

Behavioral: Internet-based educational intervention

Control group

NO INTERVENTION

In the control group, teens will continue the usual school provided sexual education and will be invited to answer the internet-based self-applied questionnaire at the same time as the intervention group.

Interventions

The intervention will include four educational sessions about risky sexual behaviors and its prevention. The intervention will last one month (one session per week) followed by a three-month follow-up. Teens will be allowed to access to a weekly session at any time and as often as he/she likes.

Internet-based educational intervention

Eligibility Criteria

Age14 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents between 14 and 15 years of age, who are in the third year of public secondary schools and attend to schools that were selected through simple random sampling from the list of public secondary schools in the Iztapalapa Delegation in Mexico City
  • Who agree to participate through informed consent; also, their parents must sign the written informed consent.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Doubova SV, Martinez-Vega IP, Infante-Castaneda C, Perez-Cuevas R. Effects of an internet-based educational intervention to prevent high-risk sexual behavior in Mexican adolescents. Health Educ Res. 2017 Dec 1;32(6):487-498. doi: 10.1093/her/cyx074.

  • Doubova SV, Infante-Castaneda C, Perez-Cuevas R. Internet-based educational intervention to prevent risky sexual behaviors in Mexican adolescents: study protocol. BMC Public Health. 2016 Apr 18;16:343. doi: 10.1186/s12889-016-2990-4.

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Epidemiology and Health Services Research Unit

Study Record Dates

First Submitted

February 11, 2016

First Posted

February 19, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 31, 2017

Record last verified: 2017-01