Sexually Transmitted DiseasesnotijovesNCT03986567
The "Notijoves" Randomised Controlled
A study testing gamification for partner notification among youngsters in people with Sexually Transmitted Diseases, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- gamification for partner notification among youngsters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Already participated in the study within its length
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Catalan Institute of Health (Ics)
Sabadell, Barcelona, 08202
Gemma Falguera-Puig, PhD, +34 936932732, gfalguera.mn.ics@gencat.cat
About this study
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
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.
Read more
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.
- Conditions
- Sexually Transmitted Diseases
- Being tested
- gamification for partner notification among youngsters
- Keywords
- Mobile Applications, Contact Tracing, Game Theory, Adolescent
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamification for partner notification among youngstersBehavioural
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 group | Role | What they receive |
|---|---|---|
| control | Active comparator | Providing with a paper notification card to the STI diagnosed young person Receives: 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 Receives: 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 Receives: Behavioral: gamification for partner notification among youngsters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of partner notification: number of partners notified out of number of cases diagnosed
number of partners notified out of number of cases diagnosed
Measured: 2 months after diagnose
Secondary outcomes (1)
yield of early diagnosis and treatment of those exposed and infected;
number of partners exposed out of number of cases diagnosed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Jun 2017
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català d'Oncologia
- Responsible party
- Sponsor
- Investigators
- GEMMA FALGUERA PUIG, PhD, Principal investigator, CATALAN INSTITUTE OF HEALTH (ICS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986567
- Sponsor's protocol ID
- 40547236
- Acronym
- notijoves
- Status last verified
- Oct 2018
- First submitted
- 15 Nov 2018
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03986567
- Acronym / sponsor ID
- notijoves / 40547236
- Conditions
- Sexually Transmitted Diseases
- Keywords
- Mobile Applications, Contact Tracing, Game Theory, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Català d'Oncologia
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Behavioral: gamification for partner notification among youngstersProviding with a paper notification card to the STI diagnosed young person |
| intervention web app | Experimental | Behavioral: gamification for partner notification among youngstersproviding to the STI diagnosed young person, with a code number to enter into the app to notify sexual partners |
| intervention game | Experimental | Behavioral: gamification for partner notification among youngstersproviding 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 |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Already participated in the study within its length
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gamification for partner notification among youngstersDesign 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 | Behavioural | control, intervention game, intervention web app |
Primary outcome
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
1 secondary outcome
yield of early diagnosis and treatment of those exposed and infected;
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GEMMA FALGUERA PUIG, PhD principal investigator
CATALAN INSTITUTE OF HEALTH (ICS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gamification for partner notification among youngsters in people with Sexually Transmitted Diseases, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DOLORS CARNICER-PONT, PhD (+34616688195, dcarnicer@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of partner notification: number of partners notified out of number of cases diagnosed (time frame: 2 months after diagnose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.