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<docDscr>
  <citation>
    <titlStmt>
      <titl>Study of factors affecting the lives of people treated by anti-HIV drugs in long term - FRAN09-014</titl>
      <IDNo>FRESH-PEF113-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="ABBVIE" role="">Isabelle COHEN-CODAR</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Study of factors affecting the lives of people treated by anti-HIV drugs in long term - FRAN09-014            </titl>
      <altTitl>
                    PRELUDE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF113-en            </IDNo>
      <IDNo agency="PEF">
                    113                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF113                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Isabelle COHEN-CODAR                                                                                </AuthEnty>
      <AuthEnty affiliation="ABBVIE">
        <ExtLink title="SIREN" URI="750775660" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            ABBOTT FRANCE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="" email="">
                    
                                    </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="">
                    anti-retroviral drugs (ARV) in the long term</keyword>
      <keyword vocab="" vocabURI="">
                    factors: daily life</keyword>
      <keyword vocab="" vocabURI="">
                    professional life</keyword>
      <keyword vocab="" vocabURI="">
                    social life</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                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Addiction                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Describe the factors affecting the life of individuals treated in the long term by anti-HIV drugs. Describe the factors affecting the life of individuals treated in the long term by anti-HIV drugs according to their age. Evaluate the correlation between the age, duration of seropositivity, the duration under treatment and the disorders reported. Compare the patient's view and that of his doctor concerning the factors described in the main objective.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2010-01-01"/>
      <collDate event="end" date="2010-12-31"/>
      <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 level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe clusion="I">* HIV-infected patients, treated with antiretroviral agents for at least 5 years and examined in consultation in their normal care center for monitoring their infection * Obtaining written consent for the collection and use of personal data                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health care consumption and services
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <timeMeth>One-time cross-sectional study</timeMeth>
      <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>[1000-10000[ 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>1157</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
