The "Notijoves" Randomised Controlled (notijoves)

Impact of New Communication Technologies and Gamification in the Promotion of Partner Notification of Sexually Transmitted Infections Among Young People: The "Notijoves" Randomised Controlled

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.

Study Overview

• Status: Unknown
• Conditions: Sexually Transmitted Diseases
• Intervention / Treatment: Behavioral: gamification for partner notification among youngsters

• Study Type: Interventional
• Enrollment (Anticipated): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08202
      • Recruiting
      • Catalan Institute of Health (Ics)
      • Contact: Gemma Falguera-Puig, PhD; Phone Number: +34 936932732; Email: gfalguera.mn.ics@gencat.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of partner notification: number of partners notified out of number of cases diagnosed	number of partners notified out of number of cases diagnosed	2 months after diagnose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
yield of early diagnosis and treatment of those exposed and infected;	number of partners exposed out of number of cases diagnosed	3 months

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Institut Català d'Oncologia
• Investigators: Principal Investigator: GEMMA FALGUERA PUIG, PhD, Catalan Institute of Health (Ics)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Adolescent; Mobile Applications; Contact Tracing; Game Theory
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: 40547236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No