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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohort of HIV-Seropositive Individuals Infected by Use of Intravenous drugs: Prospective Study in Marseille, Avignon, Nice and Ile-de-France</titl>
      <IDNo>FRESH-PEF60063-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)" role="">Maria Patrizia CARRIERI</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohort of HIV-Seropositive Individuals Infected by Use of Intravenous drugs: Prospective Study in Marseille, Avignon, Nice and Ile-de-France            </titl>
      <altTitl>
                    MANIF-2000 FOLLOWED BY MANIF-2                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60063-en            </IDNo>
      <IDNo agency="PEF">
                    60063                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60063                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Maria Patrizia CARRIERI                                                                                </AuthEnty>
      <AuthEnty affiliation="OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)">
        <ExtLink title="SIREN" URI="330065095" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Yolande OBADIA                                                                                </AuthEnty>
      <AuthEnty affiliation="OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)">
        <ExtLink title="SIREN" URI="330065095" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
      <fundAg>
                                            DEPARTEMENT DES BOUCHES DU RHONE                    
                                    </fundAg>
      <fundAg>
                                            SIDACTION (ECS)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)" email="maria-patrizia.carrieri@inserm.fr">
                    Maria Patrizia;CARRIERI
                                            <ExtLink title="SIREN" URI="330065095" role="organisation id"/>
                                    </contact>
      <contact affiliation="OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)" email="yolande.obadia@inserm.fr">
                    Yolande;OBADIA
                                            <ExtLink title="SIREN" URI="330065095" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    related diseases</keyword>
      <keyword vocab="" vocabURI="">
                    hepatic</keyword>
      <keyword vocab="" vocabURI="">
                    psychiatric</keyword>
      <keyword vocab="" vocabURI="">
                    genital and gynaecological</keyword>
      <keyword vocab="" vocabURI="">
                    secondary side-effects from treatment</keyword>
      <keyword vocab="" vocabURI="">
                    Health episodes</keyword>
      <keyword vocab="" vocabURI="">
                    cardiovascular</keyword>
      <keyword vocab="" vocabURI="">
                    neurological</keyword>
      <keyword vocab="" vocabURI="">
                    infectious</keyword>
      <keyword vocab="" vocabURI="">
                    prevention</keyword>
      <topcClas vocab="health theme">
                        Infectious disease medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D055552"/>
                                                </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Addiction                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">General objective: MANIF 2000 is a cohort of HIV-1 seropositive patients that have been infected through intravenous drug use. Patients should have an initial CD4 count of &gt; 300/mm3. The initial aim of this study was to compare HIV progression according to whether patients were still active addicts, substituting or sober. This goal was revised in light of the changes in HIV history with the release of highly active combination therapy and the treatment of addicts with buprenorphine substitution. MANIF 2000 has become an observational cohort study focused on risk-related sexual behaviours associated with drug addiction, as well as adherence to therapy and interaction between substitution and treatment. Secondary objectives: - To determine the impact of depression and HIV treatment adherence on clinical progression; - to determine the impact of retention in substitution treatment on virological success.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="1995-01-01"/>
      <collDate event="end" date="2006-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe clusion="I">HIV-1 or HIV-2 seropositive patients that have been infected through intravenous drug use with an initial CD4 count greater than 300/mm3 and at clinical stage A or B.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>467</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Metadata-only access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
