Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities

• Sponsor: University of Minnesota (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05651581
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 3
• Patients Per Site Per Month: 50.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Monkey Pox	Other: Online module	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Outcome Measures

Primary Outcome Measures

1. Efficacy of intervention [baseline]

   Efficacy of intervention will be measured by changes in knowledge using a survey

2. Efficacy of intervention [immediately after intervention]

   Efficacy of intervention will be measured by changes in knowledge using a survey

3. Acceptability [immediately after intervention]

   Acceptability will be measured by a validated questionnaire based on the Theoretical Framework of Acceptability.

Secondary Outcome Measures

1. risk perception [baseline]

   questionnaire

2. risk perception [immediately after intervention]

   questionnaire

3. intention to vaccinate [baseline]

   questionnaire

4. intention to vaccinate [immediately after intervention]

   questionnaire

5. confidence in public health initiatives [baseline]

   questionnaire

6. confidence in public health initiatives [immediately after intervention]

   questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Individuals who are 18 years and older

• Individuals able to read and write in English

Exclusion Criteria:

• Unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT05651581
• Other Study ID Numbers: Social Protocol
• First Posted: Dec 15, 2022
• Last Update Posted: Dec 15, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Monkeypox

Study Results

No Results Posted as of Dec 15, 2022