Sexually Transmitted DiseasesPRECARISTNCT04611919
Prevalence of Sexually Transmitted Infections (STIs) Into Prison in Reunion
An observational study of Sexually Transmitted Diseases, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases
- How many people
- 700 participants
- Where
- 1 siteReunion
- Study dates
- 19 Jun 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Screening will be offered to all adults entering prison at Domenjod prison (Reunion Island) between 01/02/2018 and 30/04/2019.
Who may be able to join
- 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,
Who cannot join
- incarcerated by transfer from another penal institution
- having had antibiotic therapy in the 3 months before the inclusion consultation.
Trial locations and contacts
1 site in 1 country.
Reunion1 site
Centre Hospitalier Universitaire de La Réunion
Saint-Denis, 97400
About this study
Official title: Prevalence of Sexually Transmitted Infections (STIs) at Entry Into Prison in Reunion
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, ...).
- Conditions
- Sexually Transmitted Diseases
- Medical subject headings
- Sexually Transmitted Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start19 Jun 2018
- Primary completion18 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Pierre MOITON, MD, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611919
- Sponsor's protocol ID
- 2016/CHU/11
- Acronym
- PRECARIST
- Status last verified
- Oct 2020
- First submitted
- 27 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sexually Transmitted Infections (STIs) at Entry Into Prison in Reunion
- ClinicalTrials.gov ID
- NCT04611919
- Acronym / sponsor ID
- PRECARIST / 2016/CHU/11
- Conditions
- Sexually Transmitted Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, ...).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Screening will be offered to all adults entering prison at Domenjod prison (Reunion Island) between 01/02/2018 and 30/04/2019.
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (2 listed)
- incarcerated by transfer from another penal institution
- having had antibiotic therapy in the 3 months before the inclusion consultation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Sexually Transmitted Infection with Chlamydia trachomatis, Neisseria gonorrheae and Mycoplasma genitalium
Time frame: Day 1
Proportion of people with a positive triplex Polymerase Chain Reaction result of detection of Chlamydia trachomatis, Neisseria gonorrheae and/or Mycoplasma genitalium on samples.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Pierre MOITON, MD principal investigator
CHU de La Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Diseases, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Sexually Transmitted Infection with Chlamydia trachomatis, Neisseria gonorrheae and Mycoplasma genitalium (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.