HIV InfectionsPREMINFNCT05983679
Prevalence of Sexually Transmitted Infections (STIs) and Coinfections in the General Population
An observational study of HIV Infections, run by CerbaXpert.
Trial summary
Prevalence of Sexually Transmitted Infections (STIs) and co-infections in the general population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Blood sample
- How many people
- 9,000 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2024to 4 Sep 2026
- How long will I take part?
- 3 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of 9,000 participants meeting all the inclusion criteria will be recruited. A participant identification list will be created and maintained at clinical investigation sites, linking the participant's personal data to the code assigned in the research. The identification list of participants will be kept on the research site in paper or digital format classified in the investigator binder.
Who may be able to join
- Subject, male or female, 18 years of age or older
- Subject capable of understanding the purpose of the research having given their free and informed written consent
- Subject presenting to the laboratory for a biological examination
- Affiliated subject or beneficiary of a social security scheme
Who cannot join
- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
About this study
Official title: Prevalence of Sexually Transmitted Infections (STIs) and Co-infections in the General Population
Prevalence of Sexually Transmitted Infections (STIs) and co-infections in the general population
- Conditions
- HIV Infections
- Being tested
- Blood sample
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Blood sample
| Study group | Role | What they receive |
|---|---|---|
| Adults | Not described Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of each STI will be assessed by the participant's positive or negative status for each pathogen, determined by the following screening tests:
HIV testing is based on finding antibodies to HIV-1 and HIV-2 and P24 antigen of the virus;
- Hepatitis B screening is based on HBsAg (hepatitis B surface antigen) research;
- Herpes screening is based on testing for antibodies to Herpes Simplex virus (HSV-1 and HSV-2);
- Papilloma virus screening is based on the HPV-HR test from a smear on the cervix;
- Chlamydia screening is based on a nucleic acid amplification (NAAT) test;
- Gonorrhea screening is based on the identification of the bacteria on a urine sample or secretions from the vagina or cervix;
- Screening for trichomoniasis is based on a molecular diagnosis that involves identifying the parasite's DNA from a genital or urinary sample;
- The detection of syphilis is based on antibody research.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start4 Dec 2024 (estimated)
- Primary completion4 Sep 2025 (estimated)
- Study completion4 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- 9,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- CerbaXpert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983679
- Sponsor's protocol ID
- PREMINF
- Acronym
- PREMINF
- Status last verified
- Apr 2024
- First submitted
- 22 Jun 2023
- Last updated
- 15 Apr 2024
- 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 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sexually Transmitted Infections (STIs) and Co-infections in the General Population
- ClinicalTrials.gov ID
- NCT05983679
- Acronym / sponsor ID
- PREMINF / PREMINF
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- CerbaXpertUniversity, hospital or other
- Study start
- 4 Dec 2024 (estimated)
- Primary completion
- 4 Sep 2025 (estimated)
- Study completion
- 4 Sep 2026 (estimated)
- First posted
- 9 Aug 2023 (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.
Prevalence of Sexually Transmitted Infections (STIs) and co-infections in the general population
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Diagnostic Test: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 9,000 participants meeting all the inclusion criteria will be recruited. A participant identification list will be created and maintained at clinical investigation sites, linking the participant's personal data to the code assigned in the research. The identification list of participants will be kept on the research site in paper or digital format classified in the investigator binder.
Key inclusion criteria (4 listed)
- Subject, male or female, 18 years of age or older
- Subject capable of understanding the purpose of the research having given their free and informed written consent
- Subject presenting to the laboratory for a biological examination
- Affiliated subject or beneficiary of a social security scheme
Key exclusion criteria (1 listed)
- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| Blood sampleBlood sample | Diagnostic test | Adults |
Primary outcome
The prevalence of each STI will be assessed by the participant's positive or negative status for each pathogen, determined by the following screening tests:
Time frame: 3 years
HIV testing is based on finding antibodies to HIV-1 and HIV-2 and P24 antigen of the virus; * Hepatitis B screening is based on HBsAg (hepatitis B surface antigen) research; * Herpes screening is based on testing for antibodies to Herpes Simplex virus (HSV-1 and HSV-2); * Papilloma virus screening is based on the HPV-HR test from a smear on the cervix; * Chlamydia screening is based on a nucleic acid amplification (NAAT) test; * Gonorrhea screening is based on the identification of the bacteria on a urine sample or secretions from the vagina or cervix; * Screening for trichomoniasis is based on a molecular diagnosis that involves identifying the parasite's DNA from a genital or urinary sample; * The detection of syphilis is based on antibody research.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by CerbaXpert.
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 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The prevalence of each STI will be assessed by the participant's positive or negative status for each pathogen, determined by the following screening tests: (time frame: 3 years). 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 15 Apr 2024.