Sexually Transmitted Infection
Conditions
Keywords
Sexually Transmitted Infection, PCR, C. trachomatis, N. gonorrhoeae, Screening
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.
Interventions
DIAGNOSTIC_TESTVaginal, Oral and anal sampling
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.
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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?
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of women accepting anal and oropharyngeal self-sampling | Baseline | acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women |
Countries
France
Outcome results
None listed