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The "Notijoves" Randomised Controlled (notijoves)

Primary Purpose

Sexually Transmitted Diseases

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

gamification for partner notification among youngsters

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring Mobile Applications, Contact Tracing, Game Theory, Adolescent

Eligibility Criteria

16 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Catalan Institute of Health (Ics)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

control

intervention web app

intervention game

Arm Description

Providing with a paper notification card to the STI diagnosed young person

providing to the STI diagnosed young person, with a code number to enter into the app to notify sexual partners

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

Outcomes

Primary Outcome Measures

Effectiveness of partner notification: number of partners notified out of number of cases diagnosed

number of partners notified out of number of cases diagnosed

Secondary Outcome Measures

yield of early diagnosis and treatment of those exposed and infected;

number of partners exposed out of number of cases diagnosed

Full Information

NCT ID

NCT03986567

First Posted

November 15, 2018

Last Updated

June 13, 2019

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Institut Català d'Oncologia

1. Study Identification

Unique Protocol Identification Number

NCT03986567

Brief Title

The "Notijoves" Randomised Controlled

Acronym

notijoves

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

June 2019 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Institut Català d'Oncologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sexually Transmitted Diseases

Keywords

Mobile Applications, Contact Tracing, Game Theory, Adolescent

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

416 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

Active Comparator

Arm Description

Providing with a paper notification card to the STI diagnosed young person

Arm Title

intervention web app

Arm Type

Experimental

Arm Description

providing to the STI diagnosed young person, with a code number to enter into the app to notify sexual partners

Arm Title

intervention game

Arm Type

Experimental

Arm Description

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 Type

Behavioral

Intervention Name(s)

gamification for partner notification among youngsters

Intervention Description

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 Measure Information:

Title

Effectiveness of partner notification: number of partners notified out of number of cases diagnosed

Description

number of partners notified out of number of cases diagnosed

Time Frame

2 months after diagnose

Secondary Outcome Measure Information:

Title

yield of early diagnosis and treatment of those exposed and infected;

Description

number of partners exposed out of number of cases diagnosed

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

DOLORS CARNICER-PONT, PhD

Phone

+34616688195

dcarnicer@iconcologia.net

First Name & Middle Initial & Last Name or Official Title & Degree

JOSEP M MANRESA DOMINGUEZ, BIOLOGIST

Phone

+34934824124

jmanresa@idiap.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GEMMA FALGUERA PUIG, PhD

Organizational Affiliation

CATALAN INSTITUTE OF HEALTH (ICS)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Catalan Institute of Health (Ics)

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08202

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gemma Falguera-Puig, PhD

Phone

+34 936932732

gfalguera.mn.ics@gencat.cat

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The "Notijoves" Randomised Controlled

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