ComdomPréservatifNCT06281626
Use of the Free Male Condom Scheme in Young Adults Aged 18 to 25
An observational study of Comdom, run by Université de Reims Champagne-Ardenne at 2 sites in France.
Trial summary
For several years, the incidence of sexually transmitted infections (STIs) has been rising sharply, while that of HIV has stagnated. This is due to the decline in condom use since the late 1990s, despite the fact that condom are considered the only effective way to prevent STIs. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Comdom
- What is being tested?
- Data collection
- How many people
- 394 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Apr 2024to 4 Jun 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: People aged 18 to 25 years.
Who may be able to join
- Aged 18 to 25 years
- Male or female
- Regardless of their sexual orientation
- Agreeing to participate in the study
Who cannot join
- Minors
- Refusing to participate in the study.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Ufr Medecine Urca
Reims, 51100
Université de Reims Champagne Ardenne
Reims, 51100
About this study
For several years, the incidence of sexually transmitted infections (STIs) has been rising sharply, while that of HIV has stagnated. This is due to the decline in condom use since the late 1990s, despite the fact that condom are considered the only effective way to prevent STIs.
In France, 40% of STIs concern young people aged 15 to 25. The national public health strategy aims to stem the circulation of HIV and eliminate STIs as a major public health problem by 2030. To achieve this, several measures have been implemented: reimbursement of male condoms on prescription (2018), 100% free contraception and prevention in sexual health consultation (2021), and more recently, free, non-prescription access to male condoms in pharmacies (end 2022).
Read the detailed description
The main objective is to describe the use of free male condoms by young adults aged 18 to 25.
- Conditions
- Comdom
- Being tested
- Data collection
- Keywords
- Young adults, condom, free condom, use of condom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| Young adults | people aged 18 to 25 years. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
use of free male condoms
use of free male condoms recorded as yes or not
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Apr 2024
- Primary completion2 Apr 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComdomStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281626
- Sponsor's protocol ID
- 2024_RIPH_01_Preservatif
- Acronym
- Préservatif
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Free Male Condom Scheme in Young Adults Aged 18 to 25
- ClinicalTrials.gov ID
- NCT06281626
- Acronym / sponsor ID
- Préservatif / 2024_RIPH_01_Preservatif
- Conditions
- Comdom
- Keywords
- Young adults, condom, free condom, use of condom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 28 Feb 2024 (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.
For several years, the incidence of sexually transmitted infections (STIs) has been rising sharply, while that of HIV has stagnated. This is due to the decline in condom use since the late 1990s, despite the fact that condom are considered the only effective way to prevent STIs.
In France, 40% of STIs concern young people aged 15 to 25. The national public health strategy aims to stem the circulation of HIV and eliminate STIs as a major public health problem by 2030. To achieve this, several measures have been implemented: reimbursement of male condoms on prescription (2018), 100% free contraception and prevention in sexual health consultation (2021), and more recently, free, non-prescription access to male condoms in pharmacies (end 2022).
Detailed description
The main objective is to describe the use of free male condoms by young adults aged 18 to 25.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adults | – | Other: Data collectionpeople aged 18 to 25 years. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People aged 18 to 25 years.
Key inclusion criteria (4 listed)
- Aged 18 to 25 years
- Male or female
- Regardless of their sexual orientation
- Agreeing to participate in the study
Key exclusion criteria (2 listed)
- Minors
- Refusing to participate in the study.
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 |
|---|---|---|
| Data collectionData collection | Other | Young adults |
Primary outcome
use of free male condoms
Time frame: Day 0
use of free male condoms recorded as yes or not
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 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comdom, run by Université de Reims Champagne-Ardenne at 2 sites in France.
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 4 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 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
use of free male condoms (time frame: Day 0). 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 12 Jun 2024.