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Completed

NCT Number: NCT05872438

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CeGIDD, Orléans, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal, Oral and anal sampling

Diagnostic Test

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.

Primary outcomes

  1. Detectability of STIs in women on multisite samples

    Time frame: Baseline

    Number and percentage percentage of additional STI diagnosed with the 3 sites sampling compared to the vaginal sampling alone

Secondary outcomes

  1. Percentage of women accepting anal and oropharyngeal self-sampling

    Time frame: Baseline

    acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: SIST'RS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 24, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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