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The "Notijoves" Randomised Controlled (notijoves)

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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

Tracking Information
First Submitted Date  ICMJE November 15, 2018
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The "Notijoves" Randomised Controlled
Official Title  ICMJE Impact of New Communication Technologies and Gamification in the Promotion of Partner Notification of Sexually Transmitted Infections Among Young People: The "Notijoves" Randomised Controlled
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Sexually Transmitted Diseases
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: control
    Providing with a paper notification card to the STI diagnosed young person
    Intervention: Behavioral: gamification for partner notification among youngsters
  • Experimental: intervention web app
    providing to the STI diagnosed young person, with a code number to enter into the app to notify sexual partners
    Intervention: Behavioral: gamification for partner notification among youngsters
  • 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
    Intervention: Behavioral: gamification for partner notification among youngsters
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2019)
416
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: DOLORS CARNICER-PONT, PhD +34616688195 dcarnicer@iconcologia.net
Contact: JOSEP M MANRESA DOMINGUEZ, BIOLOGIST +34934824124 jmanresa@idiap.cat
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986567
Other Study ID Numbers  ICMJE 40547236
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jordi Gol i Gurina Foundation
Study Sponsor  ICMJE Jordi Gol i Gurina Foundation
Collaborators  ICMJE Catalan Institute of Oncology
Investigators  ICMJE
Principal Investigator: GEMMA FALGUERA PUIG, PhD CATALAN INSTITUTE OF HEALTH (ICS)
PRS Account Jordi Gol i Gurina Foundation
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP