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

NCT05872438 | Completed

• 1 other identifier: CHRO-2022-16
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 7

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.

Conditions

Sexually Transmitted Infection

Keywords

Sexually Transmitted Infection; PCR; C. trachomatis; N. gonorrhoeae; Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of women accepting anal and oropharyngeal self-sampling

  Baseline

Study Arms (1)

Multisite sampling

OTHER

Vaginal, Oral and anal sampling for all participants

Diagnostic Test: Vaginal, Oral and anal sampling

Interventions

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.

Multisite sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women coming for STI screening at a Cegidd
• Asymptomatic or not
• Women aged at least 18 years
• Having given her consent to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (7)

CeGIDD

Orléans, 45000, France

Location

CHRU de POITIERS

Poitiers, 86021, France

Location

Centre Hospitalier de Cornouaille

Quimper, France

Location

CH de Saint Nazaire

Saint-Nazaire, France

Location

CHU de STRASBOURG

Strasbourg, 67000, France

Location

CHU de Tours

Tours, 37044, France

Location

Centre Hospitalier de Vierzon

Vierzon, France

Location

Related Publications (5)

• Prazuck T, Lanotte P, Le Moal G, Hocqueloux L, Sunder S, Catroux M, Garcia M, Perfezou P, Gras G, Plouzeau C, Leveque N, Beby-Defaux A. Pooling Rectal, Pharyngeal, and Urine Samples to Detect Neisseria gonorrhoeae, Chlamydia trachomatis, and Mycoplasma genitalium Using Multiplex Polymerase Chain Reaction Is as Effective as Single-Site Testing for Men Who Have Sex With Men. Open Forum Infect Dis. 2022 Oct 31;9(10):ofac496. doi: 10.1093/ofid/ofac496. eCollection 2022 Oct.

  PMID: 36324326 BACKGROUND

• Verougstraete N, Verbeke V, De Canniere AS, Simons C, Padalko E, Coorevits L. To pool or not to pool? Screening of Chlamydia trachomatis and Neisseria gonorrhoeae in female sex workers: pooled versus single-site testing. Sex Transm Infect. 2020 Sep;96(6):417-421. doi: 10.1136/sextrans-2019-054357. Epub 2020 May 13.

  PMID: 32404400 BACKGROUND

• Lunny C, Taylor D, Hoang L, Wong T, Gilbert M, Lester R, Krajden M, Ogilvie G. Self-Collected versus Clinician-Collected Sampling for Chlamydia and Gonorrhea Screening: A Systemic Review and Meta-Analysis. PLoS One. 2015 Jul 13;10(7):e0132776. doi: 10.1371/journal.pone.0132776. eCollection 2015.

  PMID: 26168051 BACKGROUND

• Alexander S, Ison C, Parry J, Llewellyn C, Wayal S, Richardson D, Phillips A, Smith H, Fisher M; Brighton Home Sampling Kits Steering Group. Self-taken pharyngeal and rectal swabs are appropriate for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in asymptomatic men who have sex with men. Sex Transm Infect. 2008 Nov;84(6):488-92. doi: 10.1136/sti.2008.031443.

  PMID: 19028953 BACKGROUND

• Wayal S, Llewellyn C, Smith H, Hankins M, Phillips A, Richardson D, Fisher M; Home Sampling Kit Project Steering Group. Self-sampling for oropharyngeal and rectal specimens to screen for sexually transmitted infections: acceptability among men who have sex with men. Sex Transm Infect. 2009 Feb;85(1):60-4. doi: 10.1136/sti.2008.032193. Epub 2008 Aug 15.

  PMID: 18708480 BACKGROUND

Related Links

• World Health Organization. Sexually transmitted infections

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julienne EFFA, Dr

  CHU d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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?

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 24, 2023
• Study Start: April 14, 2023
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

FR (7)