MalariaPREPAPNCT04494854
Perceptions, Representations and Experiences of Malaria Prophylaxis in Patients Born in Endemic Areas and Living in France.
An observational study of Malaria and Disease, Infectious, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Malaria, Disease, Infectious, Travel-Associated Infections
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will be offered to patients born in endemic areas and living in France.
Who may be able to join
- Major patients
- Born in malaria endemic areas and living in France
- Having malaria or not
- Ready for no opposition for participation in the protocol
Who cannot join
- Patients under guardianship or curatorship
- Patients unable to give free and informed consent
- Patients under judicial protection
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hospitalier intercommunal de Villeneuve St Georges
Villeneuve-Saint-Georges, 94190
About this study
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.
Read the detailed description
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.
- Conditions
- Malaria, Disease, Infectious, Travel-Associated Infections
- Keywords
- perception, representation, experience, questionnaire
- Medical subject headings
- Malaria, Communicable Diseases, Travel-Related Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify perceptions, representations and experiences of malaria prophylaxis in patients coming from endemic areas living in France.
The semi directive interview
Measured: Through study completion, an average of 30 minutes
Secondary outcomes (1)
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
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
Measured: Through study completion, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Sep 2020
- Primary completion1 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494854
- Sponsor's protocol ID
- PREPAP
- Acronym
- PREPAP
- Status last verified
- Jun 2023
- First submitted
- 17 Jul 2020
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions, Representations and Experiences of Malaria Prophylaxis in Patients Born in Endemic Areas and Living in France.
- ClinicalTrials.gov ID
- NCT04494854
- Acronym / sponsor ID
- PREPAP / PREPAP
- Conditions
- Malaria, Disease, Infectious, Travel-Associated Infections
- Keywords
- perception, representation, experience, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be offered to patients born in endemic areas and living in France.
Key inclusion criteria (4 listed)
- Major patients
- Born in malaria endemic areas and living in France
- Having malaria or not
- Ready for no opposition for participation in the protocol
Key exclusion criteria (3 listed)
- Patients under guardianship or curatorship
- Patients unable to give free and informed consent
- Patients under judicial protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
The semi directive interview
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Disease, Infectious, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.