NCT04611919

Brief Summary

Since the beginning of the 2000s, there has been a steady increase in the incidence of STIs in France. In Reunion, the few figures available seem to show the same phenomenon, especially for syphilis. The unfavorable socio-economic context, which is characterized by high levels of precariousness, significant population exchanges (immigration, travel) with neighboring countries, behaviors around sexuality or screening for STIs different from those observed in mainland France are all factors testify to the singularity of the Reunion island in relation to the metropolitan France with regard to the risk factors of STIs. STI management has become a priority in public health; in particular, the 2010-2014 HIV and STI control plan emphasized the need for their surveillance and screening. These are often asymptomatic infections that can cause serious complications if they are not treated (infertility, ectopic pregnancies, maternal-fetal infections, ...). Screening them in at-risk populations is therefore essential to reduce their prevalence. The prison population is a vulnerable population, possibly exposed during the incarceration but also upstream of it (generally low levels of education, over-represented disadvantaged social categories, low access and use of care, high prevalence of risky behaviors). ). Some prevalence studies of STIs in these populations have been carried out in metropolitan France, indicating a prevalence higher than that observed in the general population. There is little data on the subject for the prison population in Réunion; Given the local specificities, it seems necessary to improve the epidemiological knowledge of STIs in this prison population in Réunion, in order to be able to adapt the prevention and care measures, the conditions of detention presenting potentially aggravating situations (promiscuity, confinement). , hygienic conditions, ...).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

October 27, 2020

Last Update Submit

October 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Sexually Transmitted Infection with Chlamydia trachomatis, Neisseria gonorrheae and Mycoplasma genitalium

    Proportion of people with a positive triplex Polymerase Chain Reaction result of detection of Chlamydia trachomatis, Neisseria gonorrheae and/or Mycoplasma genitalium on samples.

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Screening will be offered to all adults entering prison at Domenjod prison (Reunion Island) between 01/02/2018 and 30/04/2019.

You may qualify if:

  • imprisoned at Domenjod prison between 01/02/2018 and on 04/30/2019
  • able to answer a questionnaire,
  • domiciled in Réunion at the time of incarceration,
  • incarceration medical examination carried out within 7 days incarceration,

You may not qualify if:

  • incarcerated by transfer from another penal institution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de La Réunion

Saint-Denis, 97400, Reunion

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marie-Pierre MOITON, MD

    CHU de La Réunion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 2, 2020

Study Start

June 19, 2018

Primary Completion

September 18, 2019

Study Completion

September 30, 2019

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations