Prevalence of Sexually Transmitted Infections (STIs) and Coinfections in the General Population

NCT05983679 | Not Yet Recruiting

• 1 other identifier: PREMINF
• Study Type: observational
• Target: 9,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prevalence of Sexually Transmitted Infections (STIs) and co-infections in the general population

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Study Arms (1)

Adults

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

Blood sample

Adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• \- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Sponsors & Collaborators

• CerbaXpert: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: August 9, 2023
• Study Start: December 4, 2024
• Primary Completion: September 4, 2025
• Study Completion (Estimated): September 4, 2026
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share