Monkey PoxNCT05651581
Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities
A study testing Online module in people with Monkey Pox, run by University of Minnesota at 1 site in United States.
Trial summary
The study team will create an online module via the REDCap platform. The module will include around 5 videos and several infographics covering the topics of symptoms, transmission, prevention, vaccination, and treatment of the monkeypox virus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monkey Pox
- What is being tested?
- Online module
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2023to 24 Aug 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who are 18 years and older
- Individuals able to read and write in English
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The study team will create an online module via the REDCap platform. The module will include around 5 videos and several infographics covering the topics of symptoms, transmission, prevention, vaccination, and treatment of the monkeypox virus. Surveys assessing the primary and secondary study endpoints will be given to participants before and after the module. The purpose of the study is to assess the efficacy and acceptability of an educational presentation on monkeypox in a cohort of individuals recruited from Rainbow Health and to secondarily assess participant risk perception, intention to vaccinate, and confidence in public health initiatives.
- Conditions
- Monkey Pox
- Being tested
- Online module
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online moduleOther
online module including around 5 videos and several infographics covering the topics of symptoms transmission, prevention, vaccination, and treatment of the monkeypox virus.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of intervention
Efficacy of intervention will be measured by changes in knowledge using a survey
Measured: baseline
Efficacy of intervention
Efficacy of intervention will be measured by changes in knowledge using a survey
Measured: immediately after intervention
Acceptability
Acceptability will be measured by a validated questionnaire based on the Theoretical Framework of Acceptability.
Measured: immediately after intervention
Secondary outcomes (6)
risk perception
questionnaire
Measured: baseline
risk perception
questionnaire
Measured: immediately after intervention
intention to vaccinate
questionnaire
Measured: baseline
intention to vaccinate
questionnaire
Measured: immediately after intervention
confidence in public health initiatives
questionnaire
Measured: baseline
confidence in public health initiatives
questionnaire
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start24 May 2023
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monkey PoxStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Mansh, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651581
- Sponsor's protocol ID
- Social Protocol
- Status last verified
- Oct 2023
- First submitted
- 26 Nov 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities
- ClinicalTrials.gov ID
- NCT05651581
- Acronym / sponsor ID
- Social Protocol
- Conditions
- Monkey Pox
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 15 Dec 2022 (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 study team will create an online module via the REDCap platform. The module will include around 5 videos and several infographics covering the topics of symptoms, transmission, prevention, vaccination, and treatment of the monkeypox virus. Surveys assessing the primary and secondary study endpoints will be given to participants before and after the module. The purpose of the study is to assess the efficacy and acceptability of an educational presentation on monkeypox in a cohort of individuals recruited from Rainbow Health and to secondarily assess participant risk perception, intention to vaccinate, and confidence in public health initiatives.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who are 18 years and older
- Individuals able to read and write in English
Key exclusion criteria (1 listed)
- Unable to provide informed consent
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 |
|---|---|---|
| Online moduleonline module including around 5 videos and several infographics covering the topics of symptoms transmission, prevention, vaccination, and treatment of the monkeypox virus. | Other | – |
Primary outcome
Efficacy of intervention
Time frame: baseline
Efficacy of intervention will be measured by changes in knowledge using a survey
Efficacy of intervention
Time frame: immediately after intervention
Efficacy of intervention will be measured by changes in knowledge using a survey
Acceptability
Time frame: immediately after intervention
Acceptability will be measured by a validated questionnaire based on the Theoretical Framework of Acceptability.
6 secondary outcomes
risk perception
Time frame: baseline
risk perception
Time frame: immediately after intervention
intention to vaccinate
Time frame: baseline
intention to vaccinate
Time frame: immediately after intervention
confidence in public health initiatives
Time frame: baseline
confidence in public health initiatives
Time frame: immediately after intervention
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 4 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Monkey Pox
Active, not recruitingPhase 1
A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine
Health Volunteer
RecruitingObservational study
Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)
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Enrolling by invitationObservational study
New York City Observational Study of Mpox Immunity
Monkeypox, Mpox
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Active, not recruitingPhase 4
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Monkeypox
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.
Matthew Mansh, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online module in people with Monkey Pox, run by University of Minnesota at 1 site in United States.
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 2 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 4 Oct 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 United States. 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?
Efficacy of intervention (time frame: baseline). The study lists 3 primary outcomes in all. 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 4 Oct 2023.