Clinical trial NCT04039711: Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections
Official title: Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections : A Large, Cross-sectional, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genital Infection
Asymptomatic Infections
Keywords: Vaginal self-sampling
STI
Genital infection
Group B streptococcus
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 1028
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants were screenned for genital infections

* performing vaginal and/or cervical classical-sampling (VCS)
* performing vaginal self-sampling (VSS)
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Bacterial infection detection rates
timeFrame: 10 days
measure: Yeast infection detection rates
timeFrame: 10 days
measure: Chlamydia trachomatis detection rates
timeFrame: 10 days
measure: Neisseria gonorrhoeae detection rates
timeFrame: 10 days
measure: Mycoplasma genitalium detection rates
timeFrame: 10 days
measure: Trichomonas vaginalis detection rates
timeFrame: 10 days
measure: Human simplex virus detection rates
timeFrame: 10 days
measure: Group B streptococcus detection rates
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: European Hospital
state: Bouches-du Rhone
Study officials:
References:
citation: 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.
citation: 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.