NCT03986567

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
Last Updated

June 14, 2019

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

November 15, 2018

Last Update Submit

June 13, 2019

Conditions

Keywords

Mobile ApplicationsContact TracingGame TheoryAdolescent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    3 months

Study Arms (3)

control

ACTIVE COMPARATOR

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

Behavioral: gamification for partner notification among youngsters

intervention web app

EXPERIMENTAL

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

intervention game

EXPERIMENTAL

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

Interventions

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

controlintervention gameintervention web app

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Already participated in the study within its length

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catalan Institute of Health (Ics)

Sabadell, Barcelona, 08202, Spain

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GEMMA FALGUERA PUIG, PhD

    CATALAN INSTITUTE OF HEALTH (ICS)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DOLORS CARNICER-PONT, PhD

CONTACT

JOSEP M MANRESA DOMINGUEZ, BIOLOGIST

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

June 14, 2019

Study Start

June 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 14, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations