DengueIRDDENGUELANCT05893134
Identification of Risk Determinants of Dengue Transmission Through Landscape Analysis
An observational study of Dengue, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
This retrospective observational study aims to determine the probability of the risk of dengue transmission through a model based on epidemiological, entomological, socioeconomic, demographic, and landscape variables in the El Vergel neighborhood in the municipality of Tapachula, Chiapas, Mexico. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dengue
- What is being tested?
- Risk Assessment
- How many people
- 196 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2023to 30 Jan 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Health District VII (DSVII) of the State Health Services (SESAs) in Chiapas, Mexico, will be asked for the database of dengue cases in the study area during the time of the implementation of the surveys (November 19 to December 5 of 2019), six months before and six months after the said period. They will be georeferenced through field visits, through the measurement of a geographical point in front of the house.
Who may be able to join
- The epidemiological information of all suspected cases of dengue with the onset of symptoms in the period from June 2019 to May 2020 that have a record on the platform of the National System for Epidemiological Surveillance will be included.
Who cannot join
- Records that do not have sufficient information for their georeferencing will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Risk Determinants of Dengue Transmission Through Landscape Analysis in the Neighborhood "El Vergel", Tapachula, Chiapas
This retrospective observational study aims to determine the probability of the risk of dengue transmission through a model based on epidemiological, entomological, socioeconomic, demographic, and landscape variables in the El Vergel neighborhood in the municipality of Tapachula, Chiapas, Mexico.
The main question it aims to answer is:
- Is it possible to identify the risk determinants of dengue transmission by developing a probabilistic model based on the landscape analysis of epidemiological, entomological, sociodemographic, and landscape variables in an endemic urban area of the municipality of Tapachula, Chiapas, Mexico? Participants will be selected from a registry obtained from the Secretary of Health of cases of dengue fever, which will be contrasted with the entomological, socioeconomic, demographic, and landscape variables in the El Vergel neighborhood in Tapachula, Chiapas, Mexico. They will be not contacted or sampled for biologic testing in any shape or form, only the data already collected from the health services will be used.
Read the detailed description
Identification of the risk determinants of dengue transmission through landscape analysis in the "El Vergel" neighborhood, Tapachula, Chiapas, Mexico Dengue is a disease transmitted mainly by the Ae. aegypti present in our region, despite vector surveillance and control activities, the circulation of the virus is constant and new strategies are required that contribute to reducing the incidence of the disease, which can be fatal. On the other hand, drones are tools already used in precision and security agriculture, among others; by means of them, it is possible to obtain high-resolution images of large areas of land. This work will use these images in combination with epidemiological, entomological, socioeconomic, and demographic data to identify the risk factors for dengue transmission in an urban area of the city of Tapachula and will generate a model that will allow defining the risk areas in the area. study.
Objective: To determine the probability of the risk of dengue transmission through a model based on epidemiological, entomological, socioeconomic, demographic, and landscape variables in the El Vergel neighborhood in the municipality of Tapachula, Chiapas.
Material and methods: Information from entomological, housing condition, and sociodemographic surveys of the El Vergel neighborhood, Tapachula, Chiapas, obtained during the period from November to December 2019, will be used. In addition to epidemiological information on the incidence of dengue and the placement of ovitraps in the study area during the sampling period, six months before and six months after. Specialized cartography will be used, made from fine-scale aerial photographs taken at a height of 100m by a multirotor drone with six DJI Matrice 600 model rotors with two types of cameras, a Zenmuse X5 model that captures images in the visible spectrum at 16 MP and a multispectral camera with five spectral bands MicaSense RedEdge -MX with RGB sensor with a spatial resolution of 5 cm per pixel. The images were taken simultaneously with the entomological, socioeconomic, and demographic surveys. Georeferenced orthophoto cartographic maps, digital surface models, digital terrain models, and specialized cartography of vegetation indices will be used: Normalized Difference Vegetation Index (NDVI), Difference Vegetation Index Green Normalized (GNDVI), RedEdge Normalized Difference Vegetation Index (NDVIRe) and Chlorophyll Index (CIGreen), height and diameter of the trees present in the study area, to take various variables related to the landscape (environmental variables). The data analysis will be based on a mathematical model based on the principle of partial least squares, to determine the spatial association between the epidemiological indicators (number and georeferencing of cases), entomological (immature and adult stages of Ae. aegypti), condition index housing, sociodemographic and landscape data.
Period: 6 months Type of study: Cross-sectional, retrospective, observational. Selection criteria: The construction of databases will consider the houses of Colonia El Vergel, Tapachula, Chiapas, where its inhabitants of legal age, accepted through informed consent to participate in the surveys and collection of entomological and sociodemographic data in situ and aerial photographs at a height of 100m away. Homes that do not have residents will be grounds for exclusion, and those in which the participants do not allow the collection of complete information will be eliminated.
Sample size and sampling: A multi-stage stratified sampling will be used to select dwellings. The sample size will be obtained according to the sample formula for proportions, which was calculated in n=196 dwellings.
Results: A probabilistic risk model will be generated based on the variables of different natures used and maps will be built to identify the areas of greatest risk for dengue transmission in the study area.
Conclusion: Generate scientific evidence that allows maximum use of these advances for the benefit of populations. The determination of risk areas using specialized cartography carried out using high-resolution aerial photography using drones, has already been demonstrated and recently published.
- Conditions
- Dengue
- Being tested
- Risk Assessment
- Keywords
- dengue fever, risk determinants, landscape analysis
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk AssessmentOther
A probabilistic risk model will be generated based on the variables of different natures used and maps will be built to identify the areas of greatest risk for dengue transmission in the study area
| Study group | Role | What they receive |
|---|---|---|
| Main | Information from entomological, housing condition, and sociodemographic surveys of the El Vergel neighborhood, Tapachula, Chiapas, obtained during the period from November to December 2019, will be used Receives: Other: Risk Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk
A probabilistic risk model will be generated based on the variables of different natures used and maps will be built to identify the areas of greatest risk for dengue transmission in the study area
Measured: One year, six months previous to the survey application (November-December 2019) and six months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jun 2023
- Primary completion31 Jul 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for DengueStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Collaborators
- Instituto Nacional de Salud Publica, Mexico, Centro de Investigación en Matemáticas A.C. (CIMAT)
- Responsible party
- Principal investigator, Héctor Armando Rincón León, Instituto Mexicano del Seguro Social
- Investigators
- Héctor A Rincón León, PhD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893134
- Sponsor's protocol ID
- F-CNIC-2023-060
- Acronym
- IRDDENGUELA
- Status last verified
- Mar 2024
- First submitted
- 26 May 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information of the participating subjects will only be used for the selection of homes with dengue cases, they will not be contacted or any sample will be obtained, or any drug will be used in them. Therefore, the personal information of the subjects will not be shared in order not to compromise their confidentiality.
Publications
Gubler DJ. Dengue and dengue hemorrhagic fever. Clin Microbiol Rev. 1998 Jul;11(3):480-96. doi: 10.1128/CMR.11.3.480.
PubMed 9665979Bennett JE, Dolin R, Blaser MJ, editores. Mandell, Douglas, and Bennett's principles and practice of infectious diseases. Ninth edition. Philadelphia, PA: Elsevier; 2020. 1 p.
World Health Organization. (2012). Global strategy for dengue prevention and control 2012-2020. World Health Organization. https://apps.who.int/iris/handle/10665/75303
Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI. The global distribution and burden of dengue. Nature. 2013 Apr 25;496(7446):504-7. doi: 10.1038/nature12060. Epub 2013 Apr 7.
PubMed 23563266Brady OJ, Gething PW, Bhatt S, Messina JP, Brownstein JS, Hoen AG, Moyes CL, Farlow AW, Scott TW, Hay SI. Refining the global spatial limits of dengue virus transmission by evidence-based consensus. PLoS Negl Trop Dis. 2012;6(8):e1760. doi: 10.1371/journal.pntd.0001760. Epub 2012 Aug 7.
PubMed 22880140Kuhn RJ, Zhang W, Rossmann MG, Pletnev SV, Corver J, Lenches E, Jones CT, Mukhopadhyay S, Chipman PR, Strauss EG, Baker TS, Strauss JH. Structure of dengue virus: implications for flavivirus organization, maturation, and fusion. Cell. 2002 Mar 8;108(5):717-25. doi: 10.1016/s0092-8674(02)00660-8.
PubMed 11893341Guzman MG, Harris E. Dengue. Lancet. 2015 Jan 31;385(9966):453-65. doi: 10.1016/S0140-6736(14)60572-9. Epub 2014 Sep 14.
PubMed 25230594Pardo Martínez D, Ojeda Martínez B, Alonso Remedios A. Dinámica de la respuesta inmune en la infección por virus del dengue. MediSur. febrero de 2018;16:76-84.
Avirutnan P, Matangkasombut P. Unmasking the role of mast cells in dengue. Elife. 2013 Apr 30;2:e00767. doi: 10.7554/eLife.00767.
PubMed 23638302Orta-Pineda G, Abella-Medrano CA, Suzan G, Serrano-Villagrana A, Ojeda-Flores R. Effects of landscape anthropization on sylvatic mosquito assemblages in a rainforest in Chiapas, Mexico. Acta Trop. 2021 Apr;216:105849. doi: 10.1016/j.actatropica.2021.105849. Epub 2021 Jan 30.
PubMed 33524383Tun-Lin W, Kay BH, Barnes A. Understanding productivity, a key to Aedes aegypti surveillance. Am J Trop Med Hyg. 1995 Dec;53(6):595-601. doi: 10.4269/ajtmh.1995.53.595.
PubMed 8561260Scott TW, Morrison AC. Vector dynamics and transmission of dengue virus: implications for dengue surveillance and prevention strategies: vector dynamics and dengue prevention. Curr Top Microbiol Immunol. 2010;338:115-28. doi: 10.1007/978-3-642-02215-9_9.
PubMed 19802582Reinhold JM, Lazzari CR, Lahondere C. Effects of the Environmental Temperature on Aedes aegypti and Aedes albopictus Mosquitoes: A Review. Insects. 2018 Nov 6;9(4):158. doi: 10.3390/insects9040158.
PubMed 30404142Carrasco-Escobar G, Moreno M, Fornace K, Herrera-Varela M, Manrique E, Conn JE. The use of drones for mosquito surveillance and control. Parasit Vectors. 2022 Dec 16;15(1):473. doi: 10.1186/s13071-022-05580-5.
PubMed 36527116Ferraguti M, Martinez-de la Puente J, Roiz D, Ruiz S, Soriguer R, Figuerola J. Effects of landscape anthropization on mosquito community composition and abundance. Sci Rep. 2016 Jul 4;6:29002. doi: 10.1038/srep29002.
PubMed 27373794
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Determinants of Dengue Transmission Through Landscape Analysis in the Neighborhood "El Vergel", Tapachula, Chiapas
- ClinicalTrials.gov ID
- NCT05893134
- Acronym / sponsor ID
- IRDDENGUELA / F-CNIC-2023-060
- Conditions
- Dengue
- Keywords
- dengue fever, risk determinants, landscape analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Collaborators
- Instituto Nacional de Salud Publica, Mexico, Centro de Investigación en Matemáticas A.C. (CIMAT)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 7 Jun 2023 (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.
This retrospective observational study aims to determine the probability of the risk of dengue transmission through a model based on epidemiological, entomological, socioeconomic, demographic, and landscape variables in the El Vergel neighborhood in the municipality of Tapachula, Chiapas, Mexico.
The main question it aims to answer is:
- Is it possible to identify the risk determinants of dengue transmission by developing a probabilistic model based on the landscape analysis of epidemiological, entomological, sociodemographic, and landscape variables in an endemic urban area of the municipality of Tapachula, Chiapas, Mexico? Participants will be selected from a registry obtained from the Secretary of Health of cases of dengue fever, which will be contrasted with the entomological, socioeconomic, demographic, and landscape variables in the El Vergel neighborhood in Tapachula, Chiapas, Mexico. They will be not contacted or sampled for biologic testing in any shape or form, only the data already collected from the health services will be used.
Detailed description
Identification of the risk determinants of dengue transmission through landscape analysis in the "El Vergel" neighborhood, Tapachula, Chiapas, Mexico Dengue is a disease transmitted mainly by the Ae. aegypti present in our region, despite vector surveillance and control activities, the circulation of the virus is constant and new strategies are required that contribute to reducing the incidence of the disease, which can be fatal. On the other hand, drones are tools already used in precision and security agriculture, among others; by means of them, it is possible to obtain high-resolution images of large areas of land. This work will use these images in combination with epidemiological, entomological, socioeconomic, and demographic data to identify the risk factors for dengue transmission in an urban area of the city of Tapachula and will generate a model that will allow defining the risk areas in the area. study.
Objective: To determine the probability of the risk of dengue transmission through a model based on epidemiological, entomological, socioeconomic, demographic, and landscape variables in the El Vergel neighborhood in the municipality of Tapachula, Chiapas.
Material and methods: Information from entomological, housing condition, and sociodemographic surveys of the El Vergel neighborhood, Tapachula, Chiapas, obtained during the period from November to December 2019, will be used. In addition to epidemiological information on the incidence of dengue and the placement of ovitraps in the study area during the sampling period, six months before and six months after. Specialized cartography will be used, made from fine-scale aerial photographs taken at a height of 100m by a multirotor drone with six DJI Matrice 600 model rotors with two types of cameras, a Zenmuse X5 model that captures images in the visible spectrum at 16 MP and a multispectral camera with five spectral bands MicaSense RedEdge -MX with RGB sensor with a spatial resolution of 5 cm per pixel. The images were taken simultaneously with the entomological, socioeconomic, and demographic surveys. Georeferenced orthophoto cartographic maps, digital surface models, digital terrain models, and specialized cartography of vegetation indices will be used: Normalized Difference Vegetation Index (NDVI), Difference Vegetation Index Green Normalized (GNDVI), RedEdge Normalized Difference Vegetation Index (NDVIRe) and Chlorophyll Index (CIGreen), height and diameter of the trees present in the study area, to take various variables related to the landscape (environmental variables). The data analysis will be based on a mathematical model based on the principle of partial least squares, to determine the spatial association between the epidemiological indicators (number and georeferencing of cases), entomological (immature and adult stages of Ae. aegypti), condition index housing, sociodemographic and landscape data.
Period: 6 months Type of study: Cross-sectional, retrospective, observational. Selection criteria: The construction of databases will consider the houses of Colonia El Vergel, Tapachula, Chiapas, where its inhabitants of legal age, accepted through informed consent to participate in the surveys and collection of entomological and sociodemographic data in situ and aerial photographs at a height of 100m away. Homes that do not have residents will be grounds for exclusion, and those in which the participants do not allow the collection of complete information will be eliminated.
Sample size and sampling: A multi-stage stratified sampling will be used to select dwellings. The sample size will be obtained according to the sample formula for proportions, which was calculated in n=196 dwellings.
Results: A probabilistic risk model will be generated based on the variables of different natures used and maps will be built to identify the areas of greatest risk for dengue transmission in the study area.
Conclusion: Generate scientific evidence that allows maximum use of these advances for the benefit of populations. The determination of risk areas using specialized cartography carried out using high-resolution aerial photography using drones, has already been demonstrated and recently published.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main | – | Other: Risk AssessmentInformation from entomological, housing condition, and sociodemographic surveys of the El Vergel neighborhood, Tapachula, Chiapas, obtained during the period from November to December 2019, will be used |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Health District VII (DSVII) of the State Health Services (SESAs) in Chiapas, Mexico, will be asked for the database of dengue cases in the study area during the time of the implementation of the surveys (November 19 to December 5 of 2019), six months before and six months after the said period. They will be georeferenced through field visits, through the measurement of a geographical point in front of the house.
Key inclusion criteria (1 listed)
- The epidemiological information of all suspected cases of dengue with the onset of symptoms in the period from June 2019 to May 2020 that have a record on the platform of the National System for Epidemiological Surveillance will be included.
Key exclusion criteria (1 listed)
- Records that do not have sufficient information for their georeferencing will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk AssessmentA probabilistic risk model will be generated based on the variables of different natures used and maps will be built to identify the areas of greatest risk for dengue transmission in the study area | Other | Main |
Primary outcome
Risk
Time frame: One year, six months previous to the survey application (November-December 2019) and six months after
A probabilistic risk model will be generated based on the variables of different natures used and maps will be built to identify the areas of greatest risk for dengue transmission in the study area
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 5 Mar 2024.
- Background: PubMed 9665979Gubler DJ. Dengue and dengue hemorrhagic fever. Clin Microbiol Rev. 1998 Jul;11(3):480-96. doi: 10.1128/CMR.11.3.480.
- BackgroundBennett JE, Dolin R, Blaser MJ, editores. Mandell, Douglas, and Bennett's principles and practice of infectious diseases. Ninth edition. Philadelphia, PA: Elsevier; 2020. 1 p.
- BackgroundWorld Health Organization. (2012). Global strategy for dengue prevention and control 2012-2020. World Health Organization. https://apps.who.int/iris/handle/10665/75303
- Background: PubMed 23563266Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI. The global distribution and burden of dengue. Nature. 2013 Apr 25;496(7446):504-7. doi: 10.1038/nature12060. Epub 2013 Apr 7.
- Background: PubMed 22880140Brady OJ, Gething PW, Bhatt S, Messina JP, Brownstein JS, Hoen AG, Moyes CL, Farlow AW, Scott TW, Hay SI. Refining the global spatial limits of dengue virus transmission by evidence-based consensus. PLoS Negl Trop Dis. 2012;6(8):e1760. doi: 10.1371/journal.pntd.0001760. Epub 2012 Aug 7.
- Background: PubMed 11893341Kuhn RJ, Zhang W, Rossmann MG, Pletnev SV, Corver J, Lenches E, Jones CT, Mukhopadhyay S, Chipman PR, Strauss EG, Baker TS, Strauss JH. Structure of dengue virus: implications for flavivirus organization, maturation, and fusion. Cell. 2002 Mar 8;108(5):717-25. doi: 10.1016/s0092-8674(02)00660-8.
- Background: PubMed 25230594Guzman MG, Harris E. Dengue. Lancet. 2015 Jan 31;385(9966):453-65. doi: 10.1016/S0140-6736(14)60572-9. Epub 2014 Sep 14.
- BackgroundPardo Martínez D, Ojeda Martínez B, Alonso Remedios A. Dinámica de la respuesta inmune en la infección por virus del dengue. MediSur. febrero de 2018;16:76-84.
- Background: PubMed 23638302Avirutnan P, Matangkasombut P. Unmasking the role of mast cells in dengue. Elife. 2013 Apr 30;2:e00767. doi: 10.7554/eLife.00767.
- Background: PubMed 33524383Orta-Pineda G, Abella-Medrano CA, Suzan G, Serrano-Villagrana A, Ojeda-Flores R. Effects of landscape anthropization on sylvatic mosquito assemblages in a rainforest in Chiapas, Mexico. Acta Trop. 2021 Apr;216:105849. doi: 10.1016/j.actatropica.2021.105849. Epub 2021 Jan 30.
- Background: PubMed 8561260Tun-Lin W, Kay BH, Barnes A. Understanding productivity, a key to Aedes aegypti surveillance. Am J Trop Med Hyg. 1995 Dec;53(6):595-601. doi: 10.4269/ajtmh.1995.53.595.
- Background: PubMed 19802582Scott TW, Morrison AC. Vector dynamics and transmission of dengue virus: implications for dengue surveillance and prevention strategies: vector dynamics and dengue prevention. Curr Top Microbiol Immunol. 2010;338:115-28. doi: 10.1007/978-3-642-02215-9_9.
- Individual participant dataSharing planned: No. The information of the participating subjects will only be used for the selection of homes with dengue cases, they will not be contacted or any sample will be obtained, or any drug will be used in them. Therefore, the personal information of the subjects will not be shared in order not to compromise their confidentiality.
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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.
Héctor A Rincón León, PhD principal investigator
Instituto Mexicano del Seguro Social
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 Dengue, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 1 inclusion and 1 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 5 Mar 2024. 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 Mexico. 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?
Risk (time frame: One year, six months previous to the survey application (November-December 2019) and six months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05893134, which also lists 34 linked publications.
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 5 Mar 2024.