<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02234167</url>
  </required_header>
  <id_info>
    <org_study_id>Swedish Prison Program</org_study_id>
    <nct_id>NCT02234167</nct_id>
  </id_info>
  <brief_title>The Swedish Prison Program is an Intervention Prevention Program Targeting Injecting Drug Users Risk Behaviours and Infectious Diseases</brief_title>
  <acronym>SHP</acronym>
  <official_title>Svenska Häktesprogrammet, Prevention, Risk Behaviour and Infectious Diseases Among IDU.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Public Health Agency of Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swedish Prison and Probation Service</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the Swedish Prison Program which started back in 1987 and up until 2009 was&#xD;
      called &quot;The Social Medicine Remand Prison Project&quot; is to target injecting drug users (IDU)&#xD;
      with primary and secondary health interventions with regards to injecting and sexual risk&#xD;
      behaviours and infectious diseases such as hepatitis C and B, HIV and sexually transmitted&#xD;
      infections (STI).&#xD;
&#xD;
      The overall aim is to assess the effect of different prevention efforts on HIV/HCV risk&#xD;
      behaviour and disease outcome among IDUs over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Risk behaviour for IDU is sexual risk taking, i.e., sex without a condom, buying or selling&#xD;
      sex and injection risk taking, i.e., sharing needle, syringe or paraphernalia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2002</start_date>
  <completion_date type="Actual">December 31, 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <primary_purpose>Prevention</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with injection risk behaviour</measure>
    <time_frame>2002-2012</time_frame>
    <description>Have you received already used injection equipment from someone last 12 months Have you lent (away) already used injection equipment to someone last 12 months Have you shared solution and/or filter with someone last 12 months Number of people shared needles with last month Number of injections last month Number of Hepatitis C positive Number of HIV positive Number of Hepatitis B positive Number of respondenst positive for sexually transmitted infections</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with infectious diseases</measure>
    <time_frame>2002-2012</time_frame>
    <description>HIV, HCV, HBV and STI</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <condition>Having Ever Injected Drugs</condition>
  <arm_group>
    <arm_group_label>Risk behaviour and infectious diseases</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>.(among IDU)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Risk behaviour and infectious diseases</intervention_name>
    <description>through counselling, testing vaccination</description>
    <arm_group_label>Risk behaviour and infectious diseases</arm_group_label>
    <other_name>biological and behavioural</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Defined as an injecting drug user, in the prison and probation service and agree to&#xD;
             anonymously participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being defined as a non-drug user, non-injecting drug user&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SHP</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>April 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Niklas Karlsson</investigator_full_name>
    <investigator_title>PhD candidate</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02234167
org study id: Swedish Prison Program
nct id: NCT02234167
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of the Swedish Prison Program which started back in 1987 and up until 2009 was
      called "The Social Medicine Remand Prison Project" is to target injecting drug users (IDU)
      with primary and secondary health interventions with regards to injecting and sexual risk
      behaviours and infectious diseases such as hepatitis C and B, HIV and sexually transmitted
      infections (STI).

      The overall aim is to assess the effect of different prevention efforts on HIV/HCV risk
      behaviour and disease outcome among IDUs over time.
Risk behaviour for IDU is sexual risk taking, i.e., sex without a condom, buying or selling
      sex and injection risk taking, i.e., sharing needle, syringe or paraphernalia.
allocation: N/A
primary purpose: Prevention
measure: Number of participants with injection risk behaviour
time frame: 2002-2012
description: Have you received already used injection equipment from someone last 12 months Have you lent (away) already used injection equipment to someone last 12 months Have you shared solution and/or filter with someone last 12 months Number of people shared needles with last month Number of injections last month Number of Hepatitis C positive Number of HIV positive Number of Hepatitis B positive Number of respondenst positive for sexually transmitted infections
measure: Number of participants with infectious diseases
time frame: 2002-2012
description: HIV, HCV, HBV and STI
arm group label: Risk behaviour and infectious diseases
arm group type: Other
description: .(among IDU)
intervention type: Behavioral
intervention name: Risk behaviour and infectious diseases
description: through counselling, testing vaccination
arm group label: Risk behaviour and infectious diseases
other name: biological and behavioural
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Niklas Karlsson
investigator title: PhD candidate
mesh term: Communicable Diseases
mesh term: Infections