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Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities

Primary Purpose

Monkey Pox

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online module
Sponsored by
University of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Monkey Pox

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals who are 18 years and older Individuals able to read and write in English Exclusion Criteria: Unable to provide informed consent

Sites / Locations

  • University of Minnesota

Outcomes

Primary Outcome Measures

Efficacy of intervention
Efficacy of intervention will be measured by changes in knowledge using a survey
Efficacy of intervention
Efficacy of intervention will be measured by changes in knowledge using a survey
Acceptability
Acceptability will be measured by a validated questionnaire based on the Theoretical Framework of Acceptability.

Secondary Outcome Measures

risk perception
questionnaire
risk perception
questionnaire
intention to vaccinate
questionnaire
intention to vaccinate
questionnaire
confidence in public health initiatives
questionnaire
confidence in public health initiatives
questionnaire

Full Information

First Posted
November 26, 2022
Last Updated
October 3, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05651581
Brief Title
Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities
Official Title
Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
August 24, 2023 (Actual)
Study Completion Date
August 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monkey Pox

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Online module
Intervention Description
online module including around 5 videos and several infographics covering the topics of symptoms transmission, prevention, vaccination, and treatment of the monkeypox virus.
Primary Outcome Measure Information:
Title
Efficacy of intervention
Description
Efficacy of intervention will be measured by changes in knowledge using a survey
Time Frame
baseline
Title
Efficacy of intervention
Description
Efficacy of intervention will be measured by changes in knowledge using a survey
Time Frame
immediately after intervention
Title
Acceptability
Description
Acceptability will be measured by a validated questionnaire based on the Theoretical Framework of Acceptability.
Time Frame
immediately after intervention
Secondary Outcome Measure Information:
Title
risk perception
Description
questionnaire
Time Frame
baseline
Title
risk perception
Description
questionnaire
Time Frame
immediately after intervention
Title
intention to vaccinate
Description
questionnaire
Time Frame
baseline
Title
intention to vaccinate
Description
questionnaire
Time Frame
immediately after intervention
Title
confidence in public health initiatives
Description
questionnaire
Time Frame
baseline
Title
confidence in public health initiatives
Description
questionnaire
Time Frame
immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals who are 18 years and older Individuals able to read and write in English Exclusion Criteria: Unable to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Mansh, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities

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