Prevention of Diseases Induced by Chlamydia Trachomatis
Condition: Genital Chlamydia Trachomatis Infection
MeSH terms: Chlamydia Infections
Study type: Interventional

Summary: 
      The main objective of the study is to determine whether early screening and treating young
      women (<25 years of age) for genital Chlamydia Trachomatis (Ct) infection reduces the
      cumulative incidence of pelvic inflammatory disease (PID) over 24 months.

      As secondary objectives, the study aims

        -  To determine the baseline prevalence and the incidence of Ct infection;

        -  To improve knowledge on natural history of Ct infection in young women such as the rate
           and timing of progression to PID (at the beginning of the infection, at the end,
           throughout the course of infection), as well as the incidence of reinfections with Ct;

        -  To investigate the relation between host immuno-genetic factors and the clearance,
           persistence and development of late complications (PID) as an explanation for the
           inter-individual heterogeneity in the susceptibility to and course of Ct infection.
    

Detailed description: 
      In this research project, the study aims to assess a screening strategy (early screening and
      treatment of Ct genital infection in young women to prevent complications) that may be
      implemented in the future if proved efficient 7 centers are involved in the enrollment
      (university health services), and 4 centers will participate in the study within the frame of
      the follow-up and final visit (hospital gynaecology departments).

      Participants included will have to perform 4 self-taken vaginal samples linked to four online
      corresponding questionnaires, at different timeframes 6-month apart to each other (M0, M6,
      M12, M18). The first sampling (M0) will be performed at the university health service, this
      self-taken sampling could also be performed at home later in case of menstruation; the others
      (M6, M12, M18) will be performed at home (or at the university if problem of sampling kits
      receiving at home).

      Participants will be randomly assigned to one of the two following arms:

        -  in the non-intervention arm, participants will follow current guidelines of Ct screening
           (i.e. opportunistic screening only in STI clinics for women aged less than 25 years
           old), and their samples will be tested for Ct at M18 by the NRC;

        -  in the intervention arm, analyses for Ct will be carried out immediately by the NRC.

      A final visit with a hospital gynecologist is planned for all participants between M18 and
      M24 and aims at providing an extensive clinical examination to seek for potential signs of
      pelvic inflammatory disease and to treat participants if needed.

      Based on all data collected on the electronic platform through questionnaires from the
      different visits, independent experts blinded on chlamydia status will assess PID status of
      all participants (no PID, probable PID, confirmed PID).

      The duration of enrollment is planned for 36 months.

      The duration of follow-up for each patient is 18 months to 24 months.
    

Intervention name(s): Testing for Ct infection immediately; Testing for Ct infection at the end of the study
Intervention type(s): Other; Other
Intervention description(s): Self-taken vaginal samples will be immediately tested for Ct infection at the National Reference Centre (CNR) at University of Bordeaux, using a commercially available CE marketed real-time PCR assay.; Self-taken vaginal samples will be tested for Ct infection at the end of the study (M18).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Chlamydia trachomatis; Pelvic inflammatory disease