<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/NCT04494854</url>
  </required_header>
  <id_info>
    <org_study_id>PREPAP</org_study_id>
    <nct_id>NCT04494854</nct_id>
  </id_info>
  <brief_title>Perceptions, Representations and Experiences of Malaria Prophylaxis in Patients Born in Endemic Areas and Living in France.</brief_title>
  <acronym>PREPAP</acronym>
  <official_title>Perceptions, Representations and Experiences of Malaria Prophylaxis in Patients Born in Endemic Areas and Living in France.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to analyze the perceptions, representations and expe-riences of&#xD;
      malaria prophylaxis in patients born in endemic areas and living in France.&#xD;
&#xD;
      This analysis could lead to better understanding and communication between the medical&#xD;
      profession and patients in malaria. It would also provide patient-specific responses to their&#xD;
      expectations, as to their families.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malaria is the most common vector-borne (mosquito-borne) disease in the world. It is caused&#xD;
      by a parasite called Plasmodium, and is transmitted to humans by an Anopheles mosquito bite.&#xD;
      Malaria rages in most intertropical regions and in 91 countries. Hence, almost half of the&#xD;
      world's population is expose. The estimated number of cases was 219 million (CI95 = 203-262)&#xD;
      in 2018, including 200 million in Africa (92%). The number of deaths in 2017 reached 435,000,&#xD;
      of which 93% in Africa.&#xD;
&#xD;
      In 2018, in metropolitan France, the National Reference Center recorded 2,730 reported cases&#xD;
      including one case of indigenous malaria, the other cases were import cases. There were 12.8%&#xD;
      of severe forms and 84.9% of the patients were of African origin and had stayed in Africa,&#xD;
      without taking anti-malaria chemoprophylaxis.&#xD;
&#xD;
      The fight against malaria is therefore a major public health issue in the world and in&#xD;
      France, with in particular the need for better access to pre-trip consultations, in town or&#xD;
      in hospital, and improved key messages deliverance on this frequent and potentially serious&#xD;
      pathology, and also the means of protection (chemoprophylaxis, repellents and mosquito nets).&#xD;
      The role of general practitioners is essential in this fight since they represent the first&#xD;
      source of information for 60% of patients.&#xD;
&#xD;
      To this effect, Recommendations for good practice for the management of imported malaria&#xD;
      actualized and published in 2018 emphasizes these preventive measures for travelers bound for&#xD;
      endemic areas.&#xD;
&#xD;
      The non-compliance rate was estimated at 29% in a 2007 study by Pistone et al. in patients&#xD;
      from endemic areas when they are among the most affected patients. These data have not yet&#xD;
      been verified for more than 10 years, and it seems important to actualized this knowledge in&#xD;
      the light of social changes.&#xD;
&#xD;
      In addition, prevention methods borrowed from herbal medicine are sometimes offered&#xD;
      elsewhere, such as Artemisia herbal teas, despite the scientific data that caused a lack of&#xD;
      effectiveness.&#xD;
&#xD;
      Overall, few studies have explored the reasons for this obstacle to chemoprophylaxis and&#xD;
      classically proposed anti-vector measures and a better understanding could allow a better&#xD;
      delivery of information during our consultations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify perceptions, representations and experiences of malaria prophylaxis in patients coming from endemic areas living in France.</measure>
    <time_frame>Through study completion, an average of 30 minutes</time_frame>
    <description>The semi directive interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of dialogue tools allowing a better relationship of trust between doctor and patient within the framework of a prevention consultation, and better delivery of key information</measure>
    <time_frame>Through study completion, an average of 30 minutes</time_frame>
    <description>The main themes identified through thematic coding will be used to develop the basis for a medical speech expected by patients and adapted to their needs</description>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Malaria</condition>
  <condition>Disease, Infectious</condition>
  <condition>Travel-Associated Infections</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be offered to patients born in endemic areas and living in France.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patients&#xD;
&#xD;
          -  Born in malaria endemic areas and living in France&#xD;
&#xD;
          -  Having malaria or not&#xD;
&#xD;
          -  Ready for no opposition for participation in the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under guardianship or curatorship&#xD;
&#xD;
          -  Patients unable to give free and informed consent&#xD;
&#xD;
          -  Patients under judicial protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre hospitalier intercommunal de Villeneuve St Georges</name>
      <address>
        <city>Villeneuve-Saint-Georges</city>
        <zip>94190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>perception, representation, experience, questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Travel-Related Illness</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/NCT04494854
org study id: PREPAP
nct id: NCT04494854
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to analyze the perceptions, representations and expe-riences of
      malaria prophylaxis in patients born in endemic areas and living in France.

      This analysis could lead to better understanding and communication between the medical
      profession and patients in malaria. It would also provide patient-specific responses to their
      expectations, as to their families.
Malaria is the most common vector-borne (mosquito-borne) disease in the world. It is caused
      by a parasite called Plasmodium, and is transmitted to humans by an Anopheles mosquito bite.
      Malaria rages in most intertropical regions and in 91 countries. Hence, almost half of the
      world's population is expose. The estimated number of cases was 219 million (CI95 = 203-262)
      in 2018, including 200 million in Africa (92%). The number of deaths in 2017 reached 435,000,
      of which 93% in Africa.

      In 2018, in metropolitan France, the National Reference Center recorded 2,730 reported cases
      including one case of indigenous malaria, the other cases were import cases. There were 12.8%
      of severe forms and 84.9% of the patients were of African origin and had stayed in Africa,
      without taking anti-malaria chemoprophylaxis.

      The fight against malaria is therefore a major public health issue in the world and in
      France, with in particular the need for better access to pre-trip consultations, in town or
      in hospital, and improved key messages deliverance on this frequent and potentially serious
      pathology, and also the means of protection (chemoprophylaxis, repellents and mosquito nets).
      The role of general practitioners is essential in this fight since they represent the first
      source of information for 60% of patients.

      To this effect, Recommendations for good practice for the management of imported malaria
      actualized and published in 2018 emphasizes these preventive measures for travelers bound for
      endemic areas.

      The non-compliance rate was estimated at 29% in a 2007 study by Pistone et al. in patients
      from endemic areas when they are among the most affected patients. These data have not yet
      been verified for more than 10 years, and it seems important to actualized this knowledge in
      the light of social changes.

      In addition, prevention methods borrowed from herbal medicine are sometimes offered
      elsewhere, such as Artemisia herbal teas, despite the scientific data that caused a lack of
      effectiveness.

      Overall, few studies have explored the reasons for this obstacle to chemoprophylaxis and
      classically proposed anti-vector measures and a better understanding could allow a better
      delivery of information during our consultations.
observational model: Cohort
time perspective: Prospective
measure: Identify perceptions, representations and experiences of malaria prophylaxis in patients coming from endemic areas living in France.
time frame: Through study completion, an average of 30 minutes
description: The semi directive interview
measure: Identification of dialogue tools allowing a better relationship of trust between doctor and patient within the framework of a prevention consultation, and better delivery of key information
time frame: Through study completion, an average of 30 minutes
description: The main themes identified through thematic coding will be used to develop the basis for a medical speech expected by patients and adapted to their needs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Months
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Malaria
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Travel-Related Illness