Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections

Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections : A Large, Cross-sectional, Non-inferiority Trial

Screening for genital infection (GI), sexually transmitted infection (STI) and asymptomatic carriage of group B streptococcus (GBS) in pregnant women is a common reason for medical appointments. Conventional testing is performed by using vaginal and/or cervical classic sampling (VCS). Vaginal self-sampling (VSS) has progressively emerged as an alternative to VCS for STI agent screening. The use of vaginal self-sampling (VSS) could facilitate follow-ups and potentially help in the prevention of gynaecological disorders.

Study Overview

• Status: Completed
• Conditions: Asymptomatic Infections; Genital Infection
• Intervention / Treatment: Procedure: Vaginal self-sampling

• Study Type: Interventional
• Enrollment (Actual): 1028
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bouches-du Rhone
    • Marseille, Bouches-du Rhone, France, 13003
      • European Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women requiring vaginal or cervical classical sampling to screen for genital infections
• Women requiring vaginal or cervical classical sampling to screen for sexually transmitted infections (STI)
• Pregnant women requiring vaginal classical sampling to screeen for Group B streptococcus asymptomatic carriage in the eighth month of pregnancy
• Informed written consent from the patient

Exclusion Criteria:

• Person subjected to therapeutic limitation decision
• Women with intact hymen
• Active antibiotic or antifungic treatment
• Antiobiotic or antifungic treatment during the 10 days prior to inclusion

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Genital infections; Women with vaginal/cervical sampling indications

Procedure: Vaginal self-sampling; The objective is to determine the non-inferiority of vaginal self-sampling compared with vaginal/cervical classical sampling, and evaluate the possibility of using it in all clinical situations indicating the prescription of such a procedure to screen for genital infections (GIs), sexually transmitted infections (STIs) and group B streptococcus (GBS) asymptomatic carriage in pregnant women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial infection detection rates	Bacterial infection detection rates of VSS compared with VCS	10 days
Yeast infection detection rates	Yeast infection detection rates of VSS compared with VCS	10 days
Chlamydia trachomatis detection rates	Chlamydia trachomatis detection rates of VSS compared with VCS	10 days
Neisseria gonorrhoeae detection rates	Neisseria gonorrhoeae detection rates of VSS compared with VCS	10 days
Mycoplasma genitalium detection rates	Mycoplasma genitalium detection rates of VSS compared with VCS	10 days
Trichomonas vaginalis detection rates	Trichomonas vaginalis detection rates of VSS compared with VCS	10 days
Human simplex virus detection rates	Human simplex virus detection rates of VSS compared with VCS	10 days
Group B streptococcus detection rates	Group B streptococcus detection rates of VSS compared with VCS	10 days

Collaborators and Investigators

• Sponsor: Hôpital Européen Marseille

Publications and helpful links

General Publications

• Hobbs MM, van der Pol B, Totten P, Gaydos CA, Wald A, Warren T, Winer RL, Cook RL, Deal CD, Rogers ME, Schachter J, Holmes KK, Martin DH. From the NIH: proceedings of a workshop on the importance of self-obtained vaginal specimens for detection of sexually transmitted infections. Sex Transm Dis. 2008 Jan;35(1):8-13. doi: 10.1097/OLQ.0b013e31815d968d.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2015
• Primary Completion (Actual): April 6, 2018
• Study Completion (Actual): April 6, 2018

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: STI; Vaginal self-sampling; Group B streptococcus; Genital infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Asymptomatic Diseases; Infections; Communicable Diseases; Asymptomatic Infections
• Other Study ID Numbers: RCB 2014-A01250-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No