Sexual HealthNCT04714034
Real Risks of the Online World
An observational study of Sexual Health, run by University of Zurich at 1 site in Switzerland.
Trial summary
Development and validation of questionnaire/scale to assess problematic online dating app (ODA) use in a sub-cohort of the SwissPrEPared cohort study (validation sample: n=229). Longitudinal design to assess the association of problematic ODA use and sexual/mental health and substance use outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual Health
- What is being tested?
- to develop and validate a scale measuring problematic online dating app (ODA) use in sexual minorities
- How many people
- 229 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Sep 2021to 31 Jul 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-negative SwissPrEPared participants (≥ 18 years old) who are active online dating app users.
Who may be able to join
- currently engaging in online dating (i.e., using applications/websites with the aim to meet potential relationship or sexual partners or having used them actively in the past 12 months)
- Participating in the SwissPrEPared study at center Checkpoint Zurich
- German speaking
Who cannot join
- Potential participants will be excluded if they are unable to follow study procedures.
- For Inclusion/Exclusion at the SwissPrEPared study see: NCT03893188 at clinicaltrials.gov
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Epidemiology, Biostatistics and Prevention Institute
Zurich, Canton of Zurich, 8001
About this study
Official title: Real Risks of the Online World: Association of Problematic Online Dating App Use with Mental and Sexual Health Outcomes in Sexual Minorities
Development and validation of questionnaire/scale to assess problematic online dating app (ODA) use in a sub-cohort of the SwissPrEPared cohort study (validation sample: n=229). Longitudinal design to assess the association of problematic ODA use and sexual/mental health and substance use outcomes. No randomised trial, only 1 cohort which will be stratified according to severity/risk of problematic ODA use.
Read the detailed description
This project may fill an important gap of knowledge in a research area that has taken on major importance over the past few years, and has thus the potential to impact several major public health recommendations. First, considering the high penetrance of dating apps in the men who have sex with men (MSM) population (reaching 78.2% in a recent report), more than 62,000 MSM in Switzerland are estimated to use such applications. How many of them suffer from addiction or problmatic use remains unclear and our project will be the first to provide estimates of the prevalence of problematic ODA use in this particular population. Second, our project will help to clarify the impact of online dating app usage on health outcomes. By identifying drivers of the current HIV/(sexual transmitted infections (STI) epidemic in Switzerland, our project might thus provide critical information to shape future prevention measures aiming at further reducing HIV/STI incidence rates. Third, because sexual risk-taking increases with substance use and depression, it remains crucial to detect mental health outcomes early and provide adequate care to populations at high risk of HIV, or other STI, transmission. Fourth, our study might identify a new phenomenon related to high-risk sexual behaviour that may not be limited to the MSM group, but could also affect other, larger populations interacting and meeting through online communication channels. Considering that more than 41 million people are currently using dating apps in Europe, our findings might have a substantial impact on the general population. Finally, this project might provide the very first insights on the interplay between online dating, substance use, mental health and sexual risk taking. This new understanding could then help Switzerland create additional measures for preventing HIV transmission and reach the UNAIDS targets for HIV elimination by 2030.
- Conditions
- Sexual Health
- Being tested
- to develop and validate a scale measuring problematic online dating app (ODA) use in sexual minorities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to develop and validate a scale measuring problematic online dating app (ODA) use in sexual minoritiesDiagnostic test
Qualitative part: scale development and validation with testing in 3 different participant samples, i.e. preliminary testing (n=10), pilot testing (n=30-60), validation (n=300).
Quantitative part: longitudinal part conducted in the validation sample of the qualitative study part (n=300) with the aim to evaluate the association of scores in the problematic ODA use scale with sexual health and mental health outcomes.
| Study group | Role | What they receive |
|---|---|---|
| HIV-negative SwissPrePared participants who are active Online Dating App (ODA) users | Not described Receives: Diagnostic Test: to develop and validate a scale measuring problematic online dating app (ODA) use in sexual minorities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop and validate a scale measuring problematic online dating app (ODA) use
Scale development and validation will follow the FDA guidance for patient-reported outcomes and recommendations on questionnaire research. Preliminary testing, pilot-testing, and validation will be conducted in participants from the SwissPrEPared Study
Measured: single measurement (one day per participant)
Associated mental, sexual health and substance use outcomes of problematic ODA use
Evaluate the association of problematic ODA use with:
Sexual health outcomes (incident cases of STI, such as syphilis, gonorrhoea and chlamydia, or HIV), over 6 months Mental health outcomes: prevalence of psychiatric disorders, measured at baseline and 12 months, using validated questionnaires Substance use outcomes: Lifetime, 12-month, 3-month prevalence and frequency rates
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start23 Sep 2021
- Primary completion31 Dec 2022
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual HealthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, Center for Forensic Hair Analysis, Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714034
- Sponsor's protocol ID
- 2020-01545
- Other IDs
- 10001C_192814
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2020
- Last updated
- 31 Jan 2025
- 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 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Risks of the Online World: Association of Problematic Online Dating App Use with Mental and Sexual Health Outcomes in Sexual Minorities
- ClinicalTrials.gov ID
- NCT04714034
- Acronym / sponsor ID
- 2020-01545
- Conditions
- Sexual Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich, Center for Forensic Hair Analysis, Zurich
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 19 Jan 2021 (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.
Development and validation of questionnaire/scale to assess problematic online dating app (ODA) use in a sub-cohort of the SwissPrEPared cohort study (validation sample: n=229). Longitudinal design to assess the association of problematic ODA use and sexual/mental health and substance use outcomes. No randomised trial, only 1 cohort which will be stratified according to severity/risk of problematic ODA use.
Detailed description
This project may fill an important gap of knowledge in a research area that has taken on major importance over the past few years, and has thus the potential to impact several major public health recommendations. First, considering the high penetrance of dating apps in the men who have sex with men (MSM) population (reaching 78.2% in a recent report), more than 62,000 MSM in Switzerland are estimated to use such applications. How many of them suffer from addiction or problmatic use remains unclear and our project will be the first to provide estimates of the prevalence of problematic ODA use in this particular population. Second, our project will help to clarify the impact of online dating app usage on health outcomes. By identifying drivers of the current HIV/(sexual transmitted infections (STI) epidemic in Switzerland, our project might thus provide critical information to shape future prevention measures aiming at further reducing HIV/STI incidence rates. Third, because sexual risk-taking increases with substance use and depression, it remains crucial to detect mental health outcomes early and provide adequate care to populations at high risk of HIV, or other STI, transmission. Fourth, our study might identify a new phenomenon related to high-risk sexual behaviour that may not be limited to the MSM group, but could also affect other, larger populations interacting and meeting through online communication channels. Considering that more than 41 million people are currently using dating apps in Europe, our findings might have a substantial impact on the general population. Finally, this project might provide the very first insights on the interplay between online dating, substance use, mental health and sexual risk taking. This new understanding could then help Switzerland create additional measures for preventing HIV transmission and reach the UNAIDS targets for HIV elimination by 2030.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-negative SwissPrePared participants who are active Online Dating App (ODA) users | – | Diagnostic Test: to develop and validate a scale measuring problematic online dating app (ODA) use in sexual minorities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-negative SwissPrEPared participants (≥ 18 years old) who are active online dating app users.
Key inclusion criteria (3 listed)
- currently engaging in online dating (i.e., using applications/websites with the aim to meet potential relationship or sexual partners or having used them actively in the past 12 months)
- Participating in the SwissPrEPared study at center Checkpoint Zurich
- German speaking
Key exclusion criteria (2 listed)
- Potential participants will be excluded if they are unable to follow study procedures.
- For Inclusion/Exclusion at the SwissPrEPared study see: NCT03893188 at clinicaltrials.gov
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 |
|---|---|---|
| to develop and validate a scale measuring problematic online dating app (ODA) use in sexual minoritiesQualitative part: scale development and validation with testing in 3 different participant samples, i.e. preliminary testing (n=10), pilot testing (n=30-60), validation (n=300). Quantitative part: longitudinal part conducted in the validation sample of the qualitative study part (n=300) with the aim to evaluate the association of scores in the problematic ODA use scale with sexual health and mental health outcomes. | Diagnostic test | HIV-negative SwissPrePared participants who are active Online Dating App (ODA) users |
Primary outcome
Develop and validate a scale measuring problematic online dating app (ODA) use
Time frame: single measurement (one day per participant)
Scale development and validation will follow the FDA guidance for patient-reported outcomes and recommendations on questionnaire research. Preliminary testing, pilot-testing, and validation will be conducted in participants from the SwissPrEPared Study
Associated mental, sexual health and substance use outcomes of problematic ODA use
Time frame: 6 months
Evaluate the association of problematic ODA use with: Sexual health outcomes (incident cases of STI, such as syphilis, gonorrhoea and chlamydia, or HIV), over 6 months Mental health outcomes: prevalence of psychiatric disorders, measured at baseline and 12 months, using validated questionnaires Substance use outcomes: Lifetime, 12-month, 3-month prevalence and frequency rates
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Health, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 31 Jan 2025. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop and validate a scale measuring problematic online dating app (ODA) use (time frame: single measurement (one day per participant)). The study lists 2 primary outcomes in all. 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 31 Jan 2025.