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Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial.

ABSTRACT: Genital infection with Chlamydia trachomatis (Ct) is the most common bacterial sexually transmitted infection, especially among young women. Mostly asymptomatic, it can lead, if untreated, to pelvic inflammatory disease (PID), tubal factor infertility and ectopic pregnancy. Recent data suggest that Ct infections are not controlled in France and in Europe. The effectiveness of a systematic strategy for Ct screening in under-25 women remains controversial. The main objective of the i-Predict trial (Prevention of Diseases Induced by Chlamydia trachomatis) is to determine whether early screening and treatment of 18- to-24-year-old women for genital Ct infection reduces the incidence of PID over 24 months.This is a randomised prevention trial including 4000 eighteen- to twenty-four-year-old sexually active female students enrolled at five universities. The participants will provide a self-collected vaginal swab sample and fill in an electronic questionnaire at baseline and at 6, 12 and 18 months after recruitment. Vaginal swabs in the intervention arm will be analysed immediately for Ct positivity, and participants will be referred for treatment if they have a positive test result. Vaginal swabs from the control arm will be analysed at the end of the study. All visits to general practitioners, gynaecologists or gynaecology emergency departments for pelvic pain or other gynaecological symptoms will be recorded to evaluate the incidence of PID, and all participants will attend a final visit in a hospital gynaecology department. The primary endpoint measure will be the incidence of PID over 24 months. The outcome status (confirmed, probable or no PID) will be assessed by two independent experts blinded to group assignment and Ct status.This trial is expected to largely contribute to the development of recommendations for Ct screening in young women in France to prevent PID and related complications. It is part of a comprehensive approach to gathering data to facilitate decision-making regarding optimal strategies for Ct infection control. The control group of this randomised trial, following current recommendations, will allow better documentation of the natural history of Ct infection, a prerequisite to evaluating the impact of Ct screening. Characterisation of host immunogenetics will also allow identification of women at risk for complications.ClinicalTrials.gov, NCT02904811 . Registered on September 14, 2016. World Health Organisation International Clinical Trials Registry, NCT02904811. AOM, 15-0063 and P150950. Registered on September 26, 2016. A completed Standard Protocol Items : Recommendations for International Trials (SPIRIT) Checklist is available in additional file 1.

SUBMITTER: Tamarelle J

PROVIDER: S-EPMC5683219 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial.

Tamarelle Jeanne J Thiébaut Anne C M ACM Sabin Bénédicte B Bébéar Cécile C Judlin Philippe P Fauconnier Arnaud A Rahib Delphine D Méaude-Roufai Layidé L Ravel Jacques J Morré Servaas A SA de Barbeyrac Bertille B Delarocque-Astagneau Elisabeth E

Trials 20171113 1

<h4>Background</h4>Genital infection with Chlamydia trachomatis (Ct) is the most common bacterial sexually transmitted infection, especially among young women. Mostly asymptomatic, it can lead, if untreated, to pelvic inflammatory disease (PID), tubal factor infertility and ectopic pregnancy. Recent data suggest that Ct infections are not controlled in France and in Europe. The effectiveness of a systematic strategy for Ct screening in under-25 women remains controversial. The main objective of ...[more]

PMID: 29132441

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Project description:ObjectiveChlamydia trachomatis (Ct) is the most commonly reported sexually transmitted infection in the USA and causes important reproductive morbidity in women. The Centers for Disease Control and Prevention recommend routine screening of sexually active women under age 25 but not among men. Despite three decades of screening women, chlamydia prevalence in women remains high. Untested and untreated men can serve as a reservoir of infection in women, and male-screening based intervention can be an effective strategy to reduce infection in women. We assessed the impact of screening men on the Ct prevalence in women.DesignWe created an individual-based network model to simulate a realistic chlamydia epidemic on sexual contact networks for a synthetic population (n=5000). The model is calibrated to the ongoing routine screening among African American (AA) women in the USA and detailed a male-screening programme, Check It, that bundles best practices for Ct control. We used sensitivity analysis to quantify the relative importance of each intervention component.SettingCommunity-based venues in New Orleans, Louisiana, USA.ParticipantsHeterosexual AA men, aged 15 to 24, who had sex with women in the past 2 months.InterventionVenue-based screening, expedited index treatment, expedited partner treatment and rescreening.ResultsWe estimate that by annually screening 7.5% of the AA male population in the age-range, the chlamydia prevalence would be reduced relatively by 8.1% (95% CI 5.9% to 10.4%) in AA women and 8.8% (95% CI 6.9% to 10.8%) in AA men. Each man screened could prevent 0.062 (95% CI 0.030 to 0.094) cases in men and 0.204 (95% CI 0.143 to 0.267) cases in women. The model suggested the importance of intervention components ranked from high to low as venue-based screening, expedited index treatment, expedited partner treatment and rescreening.ConclusionThe findings indicated that male-screening has the potential to substantially reduce the prevalence among women in high-prevalence communities.

Dataset Information

Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial.

Publications

Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial.

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