Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities

October 3, 2023 updated by: University of Minnesota
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals who are 18 years and older
  • Individuals able to read and write in English

Exclusion Criteria:

  • Unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of intervention
Time Frame: baseline
Efficacy of intervention will be measured by changes in knowledge using a survey
baseline
Efficacy of intervention
Time Frame: immediately after intervention
Efficacy of intervention will be measured by changes in knowledge using a survey
immediately after intervention
Acceptability
Time Frame: immediately after intervention
Acceptability will be measured by a validated questionnaire based on the Theoretical Framework of Acceptability.
immediately after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
risk perception
Time Frame: baseline
questionnaire
baseline
risk perception
Time Frame: immediately after intervention
questionnaire
immediately after intervention
intention to vaccinate
Time Frame: baseline
questionnaire
baseline
intention to vaccinate
Time Frame: immediately after intervention
questionnaire
immediately after intervention
confidence in public health initiatives
Time Frame: baseline
questionnaire
baseline
confidence in public health initiatives
Time Frame: immediately after intervention
questionnaire
immediately after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Matthew Mansh, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Actual)

August 24, 2023

Study Completion (Actual)

August 24, 2023

Study Registration Dates

First Submitted

November 26, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 15, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Social Protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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