Evaluation of Multisite Sampling to Detect C. Trachomatis or N. Gonorrheae Compared With Vaginal Sampling in Women at Risk for Sexually Transmitted Infections

Not Applicable

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Patient having received antibiotic treatment covering C.trachomatis and N.gonorrheae in the month preceding the screening
Patient under guardianship or curatorship
Patient under legal protection
Pregnant or breastfeeding woman

Arm && Interventions

Group	Intervention	Description
Multisite sampling	Vaginal, Oral and anal sampling	Vaginal, Oral and anal sampling for all participants

Primary Outcome Measures

Name	Time	Method
Detectability of STIs in women on multisite samples	Baseline	Number and percentage percentage of additional STI diagnosed with the 3 sites sampling compared to the vaginal sampling alone

Secondary Outcome Measures

Name	Time	Method
Percentage of women accepting anal and oropharyngeal self-sampling	Baseline	acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women

Locations (7): Centre Hospitalier de Cornouaille
🇫🇷
Quimper, France
Centre Hospitalier de Vierzon
🇫🇷
Vierzon, France
CeGIDD
🇫🇷
Orléans, France
CHRU de POITIERS
🇫🇷
Poitiers, France
CH de Saint Nazaire
🇫🇷
Saint-Nazaire, France
CHU de STRASBOURG
🇫🇷
Strasbourg, France
CHU de Tours
🇫🇷
Tours, France