Sexual HarassmentNCT04021849
Evaluation of Virtual Course to Increase Knowledge in Sexual Harassment,Prevention and Sanction Policies of a University
A study testing Face-to-face Class and Asynchronous Virtual Class in people with Sexual Harassment, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial summary
Sexual harassment is the behavior of sexual or sexist connotation unwanted by the affected person. Despite being considered as gender-based violence, victims of sexual harassment can be of both sexes. The university is the most frequent place where university students suffer sexual harassment. Law No. Read more about this study
- Who is it for?
- Ages 14 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Harassment
- What is being tested?
- Face-to-face Class and Asynchronous Virtual Class
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 sitePeru
- Study dates
- 10 Sep 2019to 7 Feb 2020
- Phase
- Interventional
- 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 14 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Undergraduate university students enrolled in the 2019-II period of FASPA
Who cannot join
- Students who have already taken a course on sexual harassment
- Exchange students (foreigners)
- Students who have not completed the pre-test and post-tests
Trial locations and contacts
1 site in 1 country.
Peru1 site
Universidad Peruana Cayetano Heredia
San Martín de Porres, Lima region, 15102
About this study
Official title: Evaluation of a Virtual Course to Increase Knowledge in Sexual Harassment, Prevention and Sanction Policies of Cayetano Heredia Peruvian University in Pupils of the Faculty of Public Health and Administration: a Randomized Controlled Trial
Sexual harassment is the behavior of sexual or sexist connotation unwanted by the affected person. Despite being considered as gender-based violence, victims of sexual harassment can be of both sexes. The university is the most frequent place where university students suffer sexual harassment. Law No. 27942 - "Ley de Prevención y Sanción del Hostigamiento Sexual" and its amendments, includes training and prevention in sexual harassment. The Universidad Peruana Cayetano Heredia (UPCH) has a regulation for the prevention and punishment of sexual harassment. Education through the use of Information and Communications Technologies (ICT) is presented as an alternative to face-to-face classes, optimizing resources and achieving greater scope. The early, mandatory and massive dissemination at the university of a training in sexual harassment could be achieved through a virtual course. However, there is little research on the evaluation of the effectiveness of prevention programs in sexual violence in university students. The objective is to prove that taking a virtual course about sexual harassment, prevention and sanction policies of the UPCH can achieve a greater or same knowledge of the subject in the students of the UPCH, compared to a face-to-face course. The study design is a randomized controlled trial to assess the level of knowledge in this subject, whose control group is provided classes in face-to-face mode. Also, both modalities of the course will include a survey with Likert scale to measure the degree of satisfaction with the course taken. And finally, it includes a qualitative study through focus groups with the university students of the classroom and virtual classes to know their appreciations of both modalities of the course.
Read the detailed description
Main Objective:
Compare the improvement of knowledge about sexual harassment, prevention and sanction policies of the UPCH of the asynchronous virtual course with the face-to-face course in students of the UPCH.
Study Design:
A randomized control trial will compare the improvement of knowledge among who received asynchronous virtual classes and those who received face-to-face classes by applying a pre-test and 2 post-test. The pre-test and the first post-test will be taken the day of the intervention and the second post-test will be taken after a month to measure knowledge retention.
To measure the degree of satisfaction with the course modality, the intervention's day the students will take a survey with Likert scale. And separately, some students of the intervention and control group will be interview in focus groups to know their appreciations about the satisfaction perceived with the modality of the course taken.
Population:
Undergraduate university students enrolled in the 2019-II period of the Faculty of Public Health and Administration (FASPA).
Sample:
For the randomized control trial, a sample of 67 participants per group was calculated with a significance of 95%, a power of 80% and a loss of follow-up rate of 6%, to show a difference of 7% in the scores of knowledge of sexual harassment between the two groups.
For the qualitative analysis of the focus groups, for each course modality, there will be two sessions of 6 people who completed the course. However, focus groups will continue to be carried out until the sample becomes saturated, that is, until the information obtained from these meetings is redundant or the objectives of the study are clarified.
Group assignment:
Students of FASPA will be invited to participate by flyers and invitations in classrooms. Also, by e-mail they will receive an invitation with the informational consent form and a link to fill out a registration form for the ones who are interested in participating. If inclusion and exclusion criteria are met, students will be accepted to participate in the study and they will be randomly assigned to one of the two groups. Finally they will receive an e-mail confirming their participation and the available schedules for the classes.
Ethical considerations:
Students who are registered and want to participate but do not meet the inclusion and exclusion criteria of the study, will be offered the virtual course restricting the access to the evaluations.
Every participant will receive the informational consent form. Data confidentiality will be maintained. Personal identifiers will be stored in a separate database, which will be password protected and accessible only to the research team. At the end of this project, UPCH will be able to dispose of the virtual course developed in this study for the purposes that may be appropriate.
- Conditions
- Sexual Harassment
- Being tested
- Face-to-face Class, Asynchronous Virtual Class
- Keywords
- Sexual Harassment, Virtual Course, Training
- Medical subject headings
- Sexual Harassment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face ClassOther
The principal investigator will dictate a course about Sexual Harassment, Prevention and Sanction Policies of Cayetano Heredia Peruvian University using PowerPoint Presentation
Asynchronous Virtual ClassOther
Every student will have the access to a platform with an Asynchronous Virtual Class that will use the same PowerPoint Presentation of the intervention with an audio recorded by the principal investigator
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be gathered in a classroom with computers to receive an asynchronous virtual class of 45 minutes, 1 pre-test, 1 post-test and satisfaction surveys with Likert scale. This session will take 2 hours approximately. After a month, they will take a second post-test to measure retention of knowledge. The pre-test and post-tests are all the same and they all will be taken by using computer. Receives: Other: Asynchronous Virtual Class |
| Control | Sham comparator | Participants will be gathered in a classroom with computers to receive a face-to-face class of 45 minutes, 1 pre-test, 1 post-test and satisfaction surveys with Likert scale. This session will take 2 hours approximately. After a month, they will take a second post-test to measure retention of knowledge. The pre-test and post-tests are all the same and they all will be taken by using computer. Receives: Other: Face-to-face Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Knowledge about sexual harassment
Measured by the automatic score the student get after taking the tests in a web platform.
The instrument is a questionnaire made up of 20 multiple-choice questions about knowledge in sexual harassment, prevention and sanction policies of the university. Each correct question is worth 5 points so the scale range will be 0-100 points in total but then it will be converted to vigesimal score from 0 to 20 points, being the passing grade 11.00.
Measured: 3 months
Secondary outcomes (2)
Satisfaction with the course measured by a Likert-scale survey
Number of positive responses / total number of questions. The instrument is a Likert-scale survey with 9 questions about how satisfied is the student with the class session, the trainer, the class duration, the web platform, the quality of the class and others. The possible answers are: "Nothing", "Something", "A lot" and "Totally". Being the positive responses "A lot" and "Totally".
Measured: 3 months
Satisfaction with the course described by a qualitative analysis of focal groups
The focal groups will be carried out with the students of the 2 course modalities, separately. The instrument for this focus group is a questionnaire about the satisfaction with the modality of the course, the content of the course and the fulfillment of expectations of the students on the course, the trainer and the web platform.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start10 Sep 2019
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sexual HarassmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Students will be randomly assigned to one of two groups until a total of 134 participants are recruited: 67 in the intervention group and 67 in the control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireya Reyna Martínez Ipanaqué, Universidad Peruana Cayetano Heredia
- Investigators
- Mireya R Martínez Ipanaqué, B.E., Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021849
- Sponsor's protocol ID
- 103921
- Status last verified
- Mar 2020
- First submitted
- 11 Jul 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zapp D, Buelow R, Soutiea L, Berkowitz A, DeJong W. Exploring the Potential Campus-Level Impact of Online Universal Sexual Assault Prevention Education. J Interpers Violence. 2021 Mar;36(5-6):NP2324-NP2345. doi: 10.1177/0886260518762449. Epub 2018 Mar 26.
PubMed 29577841Banyard VL, Moynihan MM, Plante EG. Sexual violence prevention through bystander education: an experimental evaluation. J Community Psychol [Internet]. 2007 [cited 2019 Feb 20];35(4):463-481. Available from: http://www.ncdsv.org/images/Sex%20Violence%20Prevention%20through%20Bystander%20Education.pdf
Ley de Prevención y Sanción del Hostigamiento Sexual. Ley N° 27942. Publicado en el diario oficial El Peruano, (05 de Febrero de 2003).
Decreto legislativo que incorpora el delito de acoso, acoso sexual, chantaje sexual y difusión de imágenes, materiales audiovisuales o audios con contenido sexual al código penal, y modifica el procedimiento de sanción del hostigamiento sexual. Decreto Legislativo N° 1410. Publicado en el diario oficial El Peruano, (11 de Septiembre de 2018).
Bardales O, Ortiz Z. Hostigamiento sexual en mujeres y varones universitarios. Estudio exploratorio [Internet]. Lima: MIMP;2012 [cited 2019 Jan 14]. Available from: http://redin.pncvfs.gob.pe/images/publicacion2/hostigamiento-sexual-en-mujeres-y-varones-universitarios9.pdf
Sarmiento P, Marcelo Y, Revollar E. Aproximación a la problemática del hostigamiento sexual laboral contra mujeres. Supervisión a ministerios, gobiernos regionales y Poder Judicial [Internet]. Lima: Defensoría del Pueblo del Perú; 2018 [cited 2019 Jan 14] Serie Informe de Adjuntía - Informe N° 007 - 2018- DP/ADM. Available from: https://www.defensoria.gob.pe/wp-content/uploads/2018/07/Informe-de-Adjuntia-007-2018-DP-ADM-II.pdf
Loli S. La Prevención y Sanción del Hostigamiento Sexual. Módulo de asistencia técnica para el abordaje desde la perspectiva de género [Internet]. Lima: MIMDES; 2008 [cited 2019 Jan 20]. Available from: https://www.mimp.gob.pe/files/direcciones/dgignd/publicaciones/prevencion_sancion_hostigamiento_sexual_modulo_ACDI.pdf
Carvajal Z, Delvó P. Análisis comparativo de dos estudios sobre hostigamiento sexual en la población estudiantil de la universidad nacional. Rev Latinoam Derechos Humanos [Internet]. 2010 [cited 2019 Jan 22];21(2):83-104. Available from: http://www.revistas.una.ac.cr/index.php/derechoshumanos/article/view/1930/1832
Ministerio de Trabajo y Promoción del Empleo. Guía para prevenir el hostigamiento sexual en el ámbito laboral [Internet]. Lima: MTPE; 2011[cited 2019 Jan 20]. Available from: http://www.academia.edu/13809973/Ministerio_de_Trabajo_y_Promoción_del_Empleo
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Virtual Course to Increase Knowledge in Sexual Harassment, Prevention and Sanction Policies of Cayetano Heredia Peruvian University in Pupils of the Faculty of Public Health and Administration: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04021849
- Acronym / sponsor ID
- 103921
- Conditions
- Sexual Harassment
- Keywords
- Sexual Harassment, Virtual Course, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 16 Jul 2019 (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.
Sexual harassment is the behavior of sexual or sexist connotation unwanted by the affected person. Despite being considered as gender-based violence, victims of sexual harassment can be of both sexes. The university is the most frequent place where university students suffer sexual harassment. Law No. 27942 - "Ley de Prevención y Sanción del Hostigamiento Sexual" and its amendments, includes training and prevention in sexual harassment. The Universidad Peruana Cayetano Heredia (UPCH) has a regulation for the prevention and punishment of sexual harassment. Education through the use of Information and Communications Technologies (ICT) is presented as an alternative to face-to-face classes, optimizing resources and achieving greater scope. The early, mandatory and massive dissemination at the university of a training in sexual harassment could be achieved through a virtual course. However, there is little research on the evaluation of the effectiveness of prevention programs in sexual violence in university students. The objective is to prove that taking a virtual course about sexual harassment, prevention and sanction policies of the UPCH can achieve a greater or same knowledge of the subject in the students of the UPCH, compared to a face-to-face course. The study design is a randomized controlled trial to assess the level of knowledge in this subject, whose control group is provided classes in face-to-face mode. Also, both modalities of the course will include a survey with Likert scale to measure the degree of satisfaction with the course taken. And finally, it includes a qualitative study through focus groups with the university students of the classroom and virtual classes to know their appreciations of both modalities of the course.
Detailed description
Main Objective:
Compare the improvement of knowledge about sexual harassment, prevention and sanction policies of the UPCH of the asynchronous virtual course with the face-to-face course in students of the UPCH.
Study Design:
A randomized control trial will compare the improvement of knowledge among who received asynchronous virtual classes and those who received face-to-face classes by applying a pre-test and 2 post-test. The pre-test and the first post-test will be taken the day of the intervention and the second post-test will be taken after a month to measure knowledge retention.
To measure the degree of satisfaction with the course modality, the intervention's day the students will take a survey with Likert scale. And separately, some students of the intervention and control group will be interview in focus groups to know their appreciations about the satisfaction perceived with the modality of the course taken.
Population:
Undergraduate university students enrolled in the 2019-II period of the Faculty of Public Health and Administration (FASPA).
Sample:
For the randomized control trial, a sample of 67 participants per group was calculated with a significance of 95%, a power of 80% and a loss of follow-up rate of 6%, to show a difference of 7% in the scores of knowledge of sexual harassment between the two groups.
For the qualitative analysis of the focus groups, for each course modality, there will be two sessions of 6 people who completed the course. However, focus groups will continue to be carried out until the sample becomes saturated, that is, until the information obtained from these meetings is redundant or the objectives of the study are clarified.
Group assignment:
Students of FASPA will be invited to participate by flyers and invitations in classrooms. Also, by e-mail they will receive an invitation with the informational consent form and a link to fill out a registration form for the ones who are interested in participating. If inclusion and exclusion criteria are met, students will be accepted to participate in the study and they will be randomly assigned to one of the two groups. Finally they will receive an e-mail confirming their participation and the available schedules for the classes.
Ethical considerations:
Students who are registered and want to participate but do not meet the inclusion and exclusion criteria of the study, will be offered the virtual course restricting the access to the evaluations.
Every participant will receive the informational consent form. Data confidentiality will be maintained. Personal identifiers will be stored in a separate database, which will be password protected and accessible only to the research team. At the end of this project, UPCH will be able to dispose of the virtual course developed in this study for the purposes that may be appropriate.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Students will be randomly assigned to one of two groups until a total of 134 participants are recruited: 67 in the intervention group and 67 in the control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Asynchronous Virtual ClassParticipants will be gathered in a classroom with computers to receive an asynchronous virtual class of 45 minutes, 1 pre-test, 1 post-test and satisfaction surveys with Likert scale. This session will take 2 hours approximately. After a month, they will take a second post-test to measure retention of knowledge. The pre-test and post-tests are all the same and they all will be taken by using computer. |
| Control | Sham comparator | Other: Face-to-face ClassParticipants will be gathered in a classroom with computers to receive a face-to-face class of 45 minutes, 1 pre-test, 1 post-test and satisfaction surveys with Likert scale. This session will take 2 hours approximately. After a month, they will take a second post-test to measure retention of knowledge. The pre-test and post-tests are all the same and they all will be taken by using computer. |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Undergraduate university students enrolled in the 2019-II period of FASPA
Key exclusion criteria (3 listed)
- Students who have already taken a course on sexual harassment
- Exchange students (foreigners)
- Students who have not completed the pre-test and post-tests
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 |
|---|---|---|
| Face-to-face ClassThe principal investigator will dictate a course about Sexual Harassment, Prevention and Sanction Policies of Cayetano Heredia Peruvian University using PowerPoint Presentation | Other | Control |
| Asynchronous Virtual ClassEvery student will have the access to a platform with an Asynchronous Virtual Class that will use the same PowerPoint Presentation of the intervention with an audio recorded by the principal investigator | Other | Intervention |
Primary outcome
Level of Knowledge about sexual harassment
Time frame: 3 months
Measured by the automatic score the student get after taking the tests in a web platform. The instrument is a questionnaire made up of 20 multiple-choice questions about knowledge in sexual harassment, prevention and sanction policies of the university. Each correct question is worth 5 points so the scale range will be 0-100 points in total but then it will be converted to vigesimal score from 0 to 20 points, being the passing grade 11.00.
2 secondary outcomes
Satisfaction with the course measured by a Likert-scale survey
Time frame: 3 months
Satisfaction with the course described by a qualitative analysis of focal groups
Time frame: 3 months
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 25 Mar 2020.
- Background: PubMed 29577841Zapp D, Buelow R, Soutiea L, Berkowitz A, DeJong W. Exploring the Potential Campus-Level Impact of Online Universal Sexual Assault Prevention Education. J Interpers Violence. 2021 Mar;36(5-6):NP2324-NP2345. doi: 10.1177/0886260518762449. Epub 2018 Mar 26.
- BackgroundBanyard VL, Moynihan MM, Plante EG. Sexual violence prevention through bystander education: an experimental evaluation. J Community Psychol [Internet]. 2007 [cited 2019 Feb 20];35(4):463-481. Available from: http://www.ncdsv.org/images/Sex%20Violence%20Prevention%20through%20Bystander%20Education.pdf
- BackgroundLey de Prevención y Sanción del Hostigamiento Sexual. Ley N° 27942. Publicado en el diario oficial El Peruano, (05 de Febrero de 2003).
- BackgroundDecreto legislativo que incorpora el delito de acoso, acoso sexual, chantaje sexual y difusión de imágenes, materiales audiovisuales o audios con contenido sexual al código penal, y modifica el procedimiento de sanción del hostigamiento sexual. Decreto Legislativo N° 1410. Publicado en el diario oficial El Peruano, (11 de Septiembre de 2018).
- BackgroundBardales O, Ortiz Z. Hostigamiento sexual en mujeres y varones universitarios. Estudio exploratorio [Internet]. Lima: MIMP;2012 [cited 2019 Jan 14]. Available from: http://redin.pncvfs.gob.pe/images/publicacion2/hostigamiento-sexual-en-mujeres-y-varones-universitarios9.pdf
- BackgroundSarmiento P, Marcelo Y, Revollar E. Aproximación a la problemática del hostigamiento sexual laboral contra mujeres. Supervisión a ministerios, gobiernos regionales y Poder Judicial [Internet]. Lima: Defensoría del Pueblo del Perú; 2018 [cited 2019 Jan 14] Serie Informe de Adjuntía - Informe N° 007 - 2018- DP/ADM. Available from: https://www.defensoria.gob.pe/wp-content/uploads/2018/07/Informe-de-Adjuntia-007-2018-DP-ADM-II.pdf
- BackgroundLoli S. La Prevención y Sanción del Hostigamiento Sexual. Módulo de asistencia técnica para el abordaje desde la perspectiva de género [Internet]. Lima: MIMDES; 2008 [cited 2019 Jan 20]. Available from: https://www.mimp.gob.pe/files/direcciones/dgignd/publicaciones/prevencion_sancion_hostigamiento_sexual_modulo_ACDI.pdf
- BackgroundCarvajal Z, Delvó P. Análisis comparativo de dos estudios sobre hostigamiento sexual en la población estudiantil de la universidad nacional. Rev Latinoam Derechos Humanos [Internet]. 2010 [cited 2019 Jan 22];21(2):83-104. Available from: http://www.revistas.una.ac.cr/index.php/derechoshumanos/article/view/1930/1832
- BackgroundMinisterio de Trabajo y Promoción del Empleo. Guía para prevenir el hostigamiento sexual en el ámbito laboral [Internet]. Lima: MTPE; 2011[cited 2019 Jan 20]. Available from: http://www.academia.edu/13809973/Ministerio_de_Trabajo_y_Promoción_del_Empleo
- Individual participant dataSharing planned: No
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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.
Mireya R Martínez Ipanaqué, B.E. principal investigator
Universidad Peruana Cayetano Heredia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face Class and Asynchronous Virtual Class in people with Sexual Harassment, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
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 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 25 Mar 2020. 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 Peru. 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. Some participants in this study may receive a placebo. 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?
Level of Knowledge about sexual harassment (time frame: 3 months). 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 NCT04021849, which also lists 9 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 25 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.