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

July 19, 2023 updated by: Centre Hospitalier Régional d'Orléans

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Orléans, France, 45000
      • Poitiers, France, 86021
        • Not yet recruiting
        • CHRU de POITIERS
        • Principal Investigator:
          • Gwenaël LE MOAL, MD
        • Contact:
          • Gwenaël LE MOAL, MD
      • Saint-Nazaire, France
        • Recruiting
        • CH de Saint Nazaire
        • Contact:
          • Christophe MICHAU, MD
        • Principal Investigator:
          • Christophe MICHAU, MD
      • Strasbourg, France, 67000
        • Recruiting
        • CHU de Strasbourg
        • Contact:
          • David REY, MD
        • Principal Investigator:
          • REY David, MD
      • Tours, France, 37044
        • Recruiting
        • CHU de Tours
        • Contact:
        • Principal Investigator:
          • Guillaume GRAS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Multisite sampling
Vaginal, Oral and anal sampling for all participants
Diagnostic test: Vaginal, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Julienne EFFA, Dr, CHR d'Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2022-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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