Clinical Trials Logo

Clinical Trial Summary

Screening for STIs in MSM is based on multisite samples: urine, anal and oral for PCR targeting C. trachomatis, N. gonorrhoeae, M. genitalium and T. vaginalis, whereas only vaginal self-sampling is recommended in women. Recent publications and observations suggest that a substantial number of STIs are under diagnosed with the current recommendations. The main objective of the study is to assess the number and percentage of additional C. trachomatis and N. gonorrhoeae infections diagnosed by a multiple sampling strategy in women, particularly when the vaginal sampling is negative The secondary objective will assess the acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women.


Clinical Trial Description

1500 women will be included in 5 different screening STIs centers in France based of the prevalence of STIs in this population (10% C. trachomatis) and the hypothesis that this new strategy allows to detect 20% more underdiagnosed STIs The sequential recruitment will concern women attending at one of the 5 STIs screening centers, whether they are symptomatic or not. If they agree to participate in the study, the patients will take the samples themselves from the 3 sites (vaginal, anal and oral self-sampling) using standard swabs (brand). The sample will immediately be placed in the transport medium in each of the 3 Sigma VCM tubes labeled by the patient, depending on the collection site. The study nurse will register the inclusion of patients, identify the tubes, collect information and send them to the local laboratory for the PCR to be performed. The study will be continued until the number of patients to be included for each of the centers is obtained. The anonymized data will be entered on an Excel database. The results of the PCRs will be collected a posteriori by the IDEs to populate the database. The PCR result will be given both qualitatively (positive/negative) and CT value for C. trachomatis and N. gonorrhoeae infections. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05872438
Study type Interventional
Source Centre Hospitalier Régional d'Orléans
Contact Thierry PRAZUCK, Dr
Phone 02 38 22 95 93
Email thierry.prazuck@chr-orleans.fr
Status Recruiting
Phase N/A
Start date April 14, 2023
Completion date April 2024

See also
  Status Clinical Trial Phase
Terminated NCT03098394 - Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections N/A
Completed NCT03186183 - GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men N/A
Completed NCT05504954 - A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women: IMARA SA N/A
Terminated NCT00170534 - Intervention for Male STDs in India N/A
Completed NCT01387646 - Behavioral Intervention for Minority Adolescent Women Phase 2
Recruiting NCT04585165 - User-friendly HIV Testing and Counseling Services
Completed NCT04021953 - The People Like Us Evaluation Study N/A
Completed NCT02993185 - Making Healthy Decisions: A Trial Evaluating the "Your Move" Teen Pregnancy-prevention Intervention N/A
Active, not recruiting NCT01088542 - The Community Youth Development Study: A Test of Communities That Care N/A
Completed NCT01379599 - Brief Intervention to Reduce STDs in ER Drug Users Phase 3
Recruiting NCT05244967 - Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility
Recruiting NCT05766904 - Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections Phase 3
Completed NCT00170430 - Reducing Vaginal Infections in Women Phase 3
Completed NCT03431168 - A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV Phase 2
Recruiting NCT04446611 - Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes N/A
Completed NCT02868346 - Improving the Diagnosis of Sexually Transmitted Infections in Emergency Rooms N/A
Completed NCT02740998 - Long-Acting Progestin Contraception and the Vaginal Microbiome
Completed NCT04207151 - Expanding PrEP By Embedding Unannounced SNAPS Navigators in High STI Testing Clinical Sites N/A
Completed NCT02498067 - rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities N/A
Active, not recruiting NCT05541081 - Investigating Point-of-care Diagnostics for Sexually Transmitted Infections and Antimicrobial Resistance in Primary Care in Zimbabwe N/A