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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sexually Transmitted Infection

Intervention / Treatment
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* Diagnostic Test: Vaginal, Oral and anal sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women coming for STI screening at a Cegidd Asymptomatic or not Women aged at least 18 years Having given her consent to participate 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Comparison of screening for two hypothesis: How many and what percentage of additional STI are diagnosed with the 3 sites sampling compared to the vaginal sampling alone?
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multisite sampling<br>Vaginal, Oral and anal sampling for all participants | Diagnostic Test: Vaginal, Oral and anal sampling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detectability of STIs in women on multisite samples | Number and percentage percentage of additional STI diagnosed with the 3 sites sampling compared to the vaginal sampling alone | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women accepting anal and oropharyngeal self-sampling | acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexually Transmitted Infection, PCR, C. trachomatis, N. gonorrhoeae, Screening