Assessment of SARS-CoV-2 Seroprevalence in Detention
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      "Background France counted on January 1, 2020, 70,651 people detained, for 61,080 places.
      Overcrowding in detention is considered as risk factor for infectious diseases transmission,
      such as respiratory infections. The prison environment represents a confined environment,
      which could protect prisoners from possible external contamination. If one or more inmates
      were infected through visiting rooms, officers working in detention, or newly incarcerated
      people, an epidemic could spread more quickly in the prison community. Thus, few cases of
      COVID-19 were observed among the subjects in detention with a few weeks delay compared to the
      free world. However, detention conditions make it more difficult to detect suspicious cases.
      On the other hand, carrying out diagnostic tests is structurally more difficult to carry out
      there. Thus, given the plurality of clinical presentations, the non-optimal sensitivity of
      the SARS-CoV-2 RT-PCR, and the difficulty in carrying out diagnostic tests, it is today
      difficult to have a precise idea of the number of prisoners having encountered SARS-CoV-2. It
      is also a population that is not taken into account in the large seroprevalence studies
      currently conducted in the general population. In order to estimate the number of prisoners
      exposed to SARS-CoV-2 and in the absence of data currently available in the medical
      literature, a seroprevalence study in this at risk and little studied population would bring
      new data to the medical community.

      Hypothesis In adult subjects living in penal establishments in Ile de France, the
      seroprevalence of SARS-CoV-2 would be lower compared to the general population.

      Material and method Open multicenter cross-sectional study carried out in the 11 penal
      establishments of Ile de France. A sampling of 3,500 inmates stratified over the 16 detention
      areas concerned will be carried out. The inclusion criteria will be detained subjects who
      have expressed their consent to participate in the research, aged 18 to 80 years. Each
      selected detainee will be invited to the health unit to perform a venous blood test for
      anti-SARS-CoV-2 antibodies. The goal is to take 2,500 blood samples (30% expected refusal
      rate). Each sample will be analyzed in the virology laboratory at P. Brousse hospital.

      Expected results Obtain an assessment of the seroprevalence of SARS-CoV-2 in prisons to
      determine the exposure of detained persons. This assessment will make it possible to
      undertake public health actions and to propose the implementation of group protection
      measures such as vaccination if this is soon available.
    

Detailed description: 
      "

        1. Scientific justification for the research

           o Current knowledge

           SARS-CoV-2, a new coronavirus infecting human, is responsible for the COVID-19 pandemic.
           The virus is transmitted either directly through the projection of contaminated droplets
           during a cough or sneeze, or indirectly through contact via an inert contaminated
           surface. The recent occurrence of the COVID-19 epidemic and the originality of the
           situation, both nationally and internationally, do not currently allow data describing
           the epidemic in prison, nor elements characterizing it the seroprevalence of SARS-CoV-2
           in detention.

           The medical literature currently reports some reflections on the challenges of
           SARS-CoV-2 infection in prisoners. A team recently reported an epidemic of COVID-19 in
           prison in China3, which involved more than 500 cases including male and female prison
           staff and detainees.

           A recent publication reported that the infectious period of SARS-CoV-2 begins two to
           three days before the onset of symptoms4. This major fact could limit the effectiveness
           of the strategy currently adopted in detention to isolate everyone as soon as the first
           symptoms of COVID-19 appear, even if all the identified contact subjects were also
           placed in containment and monitored and the new arrivals in detention placed in solitary
           confinement for a period of 14 days.

           On January 1, 2020, France had 70,651 people detained, for 61,080 places. This
           overcrowding is concentrated in certain prisons which house 2/3 of the prison
           population, so the occupancy rate can reach 138%, forcing two to three people -
           sometimes more - to share the same cell. Overcrowding and overcrowding in detention are
           considered to be risk factors for the transmission of infectious diseases compared to
           the open environment, in particular for respiratory viruses. Thus, epidemics of
           influenza have been reported there in the United States and recently epidemics of
           SARS-CoV-2 in China.

           Since January 24, 2020, the date on which a Chinese tourist visiting France was
           identified as the first case infected with SARS-CoV-2 on the territory, the epidemic has
           spread widely in the general population, putting in straining the healthcare system and
           having led to major decisions aimed at reducing its transmission. While on February 25
           died the first French patient following a COVID-19, almost three weeks later died of
           this disease, the first patient detained. He had been incarcerated eight days earlier.
           The rapid spread of the epidemic in the free world and the occurrence of this first
           death in detention then raised fears of an epidemic in prison. However, the prison
           environment alone represents a confined environment, which could protect prisoners from
           possible external contamination. According to some authors, the attack rate varies
           according to the number of people living in ""closed societies"" and the nature of their
           interactions and is not different from that observed in the general population.

           To reduce the risk of detainees being exposed to SARS-CoV-2, measures such as the early
           release agreement, the reduction in the number of arrivals, and the suspension of
           visiting rooms have been put in place. Thus, the number of prisoners in French prisons
           decreased by 6,266 people between March 16 and April 1.

           Although these actions were put in place, measures to limit human-to-human contamination
           of SARS-CoV-2 were difficult to apply at the start of the epidemic in the absence of
           sufficient supplies. Thus, in certain detentions, several grouped cases of COVID-19 have
           been observed among caregivers and prison staff. It is not excluded that these agents
           could have contaminated detained persons who run the risk of being disseminated to the
           incarcerated population because of the existing promiscuity.

           A few confirmed cases of COVID-19 have thus been observed among subjects detained a few
           weeks late compared to the free world in penal establishments in Ile de France, which
           corroborates the fact that the virus is present and circulating in the prison community.
           However, conditions of detention make it more difficult to detect suspicious cases,
           since detainees do not wish to be stigmatized among their fellow prisoners, tend to
           minimize or conceal their symptoms and thus make it less easy to consult the detention
           health unit (medical service). On the other hand, carrying out diagnostic tests is
           structurally more complex. In addition, the plurality of clinical presentations, the
           sensitivity of the SARS-CoV-2 RT-PCR which does not exceed 70% 10, and the difficulty in
           carrying out diagnostic tests, does not allow a precise idea of the number of inmates
           who encountered SARS-CoV-2.

           o Research hypotheses

           The seroprevalence of SARS-CoV-2 would be lower in detention compared to the general
           population.

           o Description of the population to be studied

           Population of adult subjects detained in penal institutions in Ile-de-France. The
           characterization of this specific population is necessary in France because no study to
           date reports data concerning this fragile and confined population due to the conditions
           of detention. Ile-de-France is one of the two regions with the Great East most affected
           by SARS-CoV-2.

        2. Research objectives

           o Main objective of the research

           The main objective of the research is to assess the prevalence of SARS-CoV-2 infection
           among subjects detained in penal institutions in Ile-de-France.

           o Secondary research objectives

           The secondary objectives are:

             -  Compare this prevalence to that of the general population

             -  Describe the clinical forms in prisoners with a positive SARS-CoV-2 serology

             -  Describe the characteristics and co-morbidities associated with a positive
                SARS-CoV-2 serology in detained subjects.

             -  Evaluate the perception of the risk, the knowledge of the barrier measures and the
                recourse to care in case of symptoms in the detained subjects.

        3. Description of the research methodology

           o Experimental design

           This is a multi-center cross-sectional seroprevalence study.

             -  Number of participating centers Eleven penal establishments in Ile de France. The
                subjects will be recruited from the health units of penal establishments in Ile de
                France. These health units are all attached to hospitals.

             -  Sample design

           Unit investigated: individual aged 18 to 80 detained in one of the 16 detention areas of
           the eleven prison centers in Ile-de-France.

           Sample size: the calculation of the number of subjects required results in 2500
           subjects, a sampling of 3600 prisoners will therefore be carried out by probabilistic
           survey from the lists of prisoners provided by each center taking into account a
           probable rate of refusal of participation or release from detention between selection
           and inclusion of 30% (observed in a previous study).

        4. Research process 4.1.1 Research calendar

             -  Maximum time between selection and inclusion: 4 months

             -  Duration of the inclusion period: 4 months 4.1.2 Selection visit

           No selection visit will be made, each participant drawn will receive a letter explaining
           the purpose and course of this research and inviting him to participate, the study
           information note will be attached to this letter. The letter will include a reply coupon
           which will be sent by the participant to the health unit if he wishes to participate in
           the research. Subjects who have thus responded positively will be invited to go to the
           health unit for the inclusion visit. If the subject does not appear at the health unit
           after a first invitation, a second invitation will be sent to him, if this second
           invitation is not honored, the subject will not be included in the study.

           4.1.3 Inclusion visit

             -  The inclusion of subjects will take place in the health units of penitentiary
                establishments during a medical consultation. This visit will be provided by a
                doctor from the health unit and a nurse. During this visit, the investigative team:

             -  Check the inclusion and non-inclusion criteria.

             -  Explains the objective and the course of the research and obtains the signed
                consent. If the participant does not understand French, the investigator uses a
                translator.

             -  Performs physical and clinical examination

             -  Collects demographic and medical history data.

             -  Carries out an interrogation in connection with the COVID-19 disease: Interrogates
                the subject to gather information concerning the possible symptoms in connection
                with COVID-19 felt since the end of February, the recourse to possible care, the
                factors supposed in connection with the infection with SARS-CoV-2 and the
                occurrence of moderate to severe forms of COVID-19, then asked him questions about
                his fear of being infected, his knowledge of the transmission of the virus and the
                barrier measures to put in place.

             -  Performs peripheral venous sampling.

           The pseudo-anonymized samples will be sent to the virology laboratory at Paul Brousse
           Hospital for serological tests and the constitution of the biological collection.

           For each patient, the virology laboratory will edit and transmit, via secure messaging
           to the investigative center, the report of the serology result with the identifier of
           the participant in the research.

        5. Stopping rules 5.1.1 Criteria and methods for premature termination of participation in
           the search for a subject

           Any subject can stop participating in research and exit the study at any time and for
           any reason. The investigator may temporarily or permanently interrupt a subject's
           participation in the research for any reason that would best serve the subject's
           interests. In the event of premature termination of the search for a subject, or
           withdrawal of consent, the data concerning him collected before the premature
           termination may be used.

           5.1.2 How to replace these people, if applicable

           Subjects who prematurely stopped participating in the research will not be replaced.

           5.1.3 Stopping some or all of the research

           The promoter AP-HP reserves the right to definitively suspend the inclusions, at any
           time, if it turns out that the inclusion objectives are not met.

           Since the subjects 'participation period is less than one day, no arrangements for
           taking charge of subjects' follow-up will be put in place, in the event of premature
           cessation of research.

        6. Effectiveness assessment

           o Description of the efficacy evaluation parameters

           The immunological analyzes will be carried out under the direction of Professor
           Roque-Afonso. The teams involved in this task are those of the virology laboratory at
           Paul Brousse Hospital.

           o Determination of immunological parameters

           Blood samples will be sent to the virology laboratory / CRB Paris-Sud by a dedicated
           transporter, these samples will be centrifuged and aliquoted and stored at -80 ° C at
           CRB Paris-Sud. An aliquot will be used for the detection of anti-SARS-CoV-2 IgG by the
           SARS-CoV-2 IgG Reagent Kit test (Abbott Diagnostics) according to the manufacturer's
           recommendations.

        7. Vigilance As part of this study, adverse events (serious or not) are not to be notified
           to the sponsor. Notification must be made as part of the vigilance implemented as part
           of the treatment."
    

Intervention name(s): Blood draw
Intervention type(s): Biological
Intervention description(s): For each participants to the research a peripherical blood draw will be performed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: COVID-19; SARS-CoV-2; inmates; seroprevalence