Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The "Notijoves" Randomised Controlled (notijoves)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03986567
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Catalan Institute of Oncology
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief Summary:

Background:

Increase of sexually transmitted infections (STIs) as well as increased use of new information and communication technologies (ICTs) among young people in Catalonia triggers the idea of designing a mobile phone application to promote partner notification.

Objective:

Design a web based tool adapted to Mobile phones for partner notification of STI among youngsters 16 to 24 years old and evaluate its role in increasing the "patient referral" partner notification.

Methods:

This is a multicentre randomised controlled trial with a proportional stratification of the sample by centre and random allocation of participants to the three arms of the study (simple web based intervention, game web based intervention and control). This study is conducted by midwives, gynaecologists and physicians in the sexual and reproductive areas of the primary health care centres.

The study population is: 1- All youngsters 16 to 24 years old diagnosed with one of the three curable STIs, (Syphilis, gonococcus and chlamydia). 2- All partners of those diagnosed with the previous STIs, independently of their state of infection.


Condition or disease Intervention/treatment Phase
Sexually Transmitted Diseases Behavioral: gamification for partner notification among youngsters Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of New Communication Technologies and Gamification in the Promotion of Partner Notification of Sexually Transmitted Infections Among Young People: The "Notijoves" Randomised Controlled
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: control
Providing with a paper notification card to the STI diagnosed young person
Behavioral: gamification for partner notification among youngsters
Design a web based tool adapted to Mobile phones for partner notification of STI among youngsters 16 to 24 years old and evaluate its role in increasing the "patient referral" partner notification

Experimental: intervention web app
providing to the STI diagnosed young person, with a code number to enter into the app to notify sexual partners
Behavioral: gamification for partner notification among youngsters
Design a web based tool adapted to Mobile phones for partner notification of STI among youngsters 16 to 24 years old and evaluate its role in increasing the "patient referral" partner notification

Experimental: intervention game
providing to the STI diagnosed young person, with a code number to enter into the app and play a game to get motivated to notify sexual partners
Behavioral: gamification for partner notification among youngsters
Design a web based tool adapted to Mobile phones for partner notification of STI among youngsters 16 to 24 years old and evaluate its role in increasing the "patient referral" partner notification




Primary Outcome Measures :
  1. Effectiveness of partner notification: number of partners notified out of number of cases diagnosed [ Time Frame: 2 months after diagnose ]
    number of partners notified out of number of cases diagnosed


Secondary Outcome Measures :
  1. yield of early diagnosis and treatment of those exposed and infected; [ Time Frame: 3 months ]
    number of partners exposed out of number of cases diagnosed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 16 to 24 years old diagnosed with one of the three curable STIs, (Syphilis, gonococcus and chlamydia).
  • All partners of those diagnosed with the previous STIs, independently of their state of infection.

Exclusion Criteria:

  • Already participated in the study within its length

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986567


Contacts
Layout table for location contacts
Contact: DOLORS CARNICER-PONT, PhD +34616688195 dcarnicer@iconcologia.net
Contact: JOSEP M MANRESA DOMINGUEZ, BIOLOGIST +34934824124 jmanresa@idiap.cat

Locations
Layout table for location information
Spain
Catalan Institute of Health (Ics) Recruiting
Sabadell, Barcelona, Spain, 08202
Contact: Gemma Falguera-Puig, PhD    +34 936932732    gfalguera.mn.ics@gencat.cat   
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Catalan Institute of Oncology
Investigators
Layout table for investigator information
Principal Investigator: GEMMA FALGUERA PUIG, PhD CATALAN INSTITUTE OF HEALTH (ICS)

Layout table for additonal information
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03986567     History of Changes
Other Study ID Numbers: 40547236
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jordi Gol i Gurina Foundation:
Mobile Applications
Contact Tracing
Game Theory
Adolescent

Additional relevant MeSH terms:
Layout table for MeSH terms
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female