Prevention of Diseases Induced by Chlamydia Trachomatis (i-PREDICT)

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.

Study Overview

• Status: Completed
• Conditions: Genital Chlamydia Trachomatis Infection
• Intervention / Treatment: Other: Testing for Ct infection immediately; Other: Testing for Ct infection at the end of the study

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.

• Study Type: Interventional
• Enrollment (Actual): 1092
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Quentin-en-Yvelines
    • Versailles, Saint-Quentin-en-Yvelines, France, 78000
      • Université de Versailles Saint Quentin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• female students visiting the preventive medical centers of universities or the Ct screening test centers who participate in the study;
• participate in or will participate in the "i-Share" cohort;
• aged between 18 to 24 years,
• had prior sexual relations,
• written informed consent signed,
• affiliated to the social security bodies.

Exclusion Criteria:

• Known pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Testing for Ct infection immediately Participants will perform self-taken vaginal samples. The positive results for Ct will be examined and treated and their partner will also be informed to do so.	Other: Testing for Ct infection immediately; 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.
Experimental: Control group; Testing for Ct infection at the end of the study	Other: Testing for Ct infection at the end of the study; Self-taken vaginal samples will be tested for Ct infection at the end of the study (M18).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence	Cumulative incidence of first PID	At 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of first Ct infection	Incidence of first Ct infection for negative participants at baseline	Up to 24 months
Duration of Ct infection		Up to 24 months
Proportion of Ct infection progressing to PID		Up to 24 months
Time of Ct infection progressing to PID		Up to 24 months
Proportion of spontaneous resolution of Ct infections	Proportion of spontaneous resolution of Ct infections	Up to 24 months
Incidence of reinfections	Incidence of reinfections	Up to 24 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: National Reference Center (NRC) for Chlamydia infections, UMR1181
• Investigators: Study Chair: Elisabeth Delarocque-Astagneau, MD, Université de Versailles Saint Quentin

Publications and helpful links

General Publications

• Tamarelle J, Thiebaut ACM, Sabin B, Bebear C, Judlin P, Fauconnier A, Rahib D, Meaude-Roufai L, Ravel J, Morre SA, de Barbeyrac B, Delarocque-Astagneau E; i-Predict study group. Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial. Trials. 2017 Nov 13;18(1):534. doi: 10.1186/s13063-017-2211-1.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Chlamydia trachomatis; Pelvic inflammatory disease
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Chlamydia Infections
• Other Study ID Numbers: P150950; AOM 15-0063 (Other Identifier: AP-HP)

Plan for Individual participant data (IPD)

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