Looking for Asymptomatic Mpox in a Population at High Risk

NCT06353737 | Recruiting

• 1 other identifier: CTO 4489
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. While the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. To do this, a Canadian sample of gay, bisexual and other men who have sex with men (GBMSM) who are participating in a randomized controlled trial will be screened for mpox symptoms. Screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. Swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. Approximately 450 individuals will be recruited. The results will be descriptive in nature.

Conditions

Mpox (Monkeypox)

Outcome Measures

Primary Outcomes (1)

• Asymptomatic prevalence

  To determine the prevalence of asymptomatic, pre-symptomatic and paucisymptomatic mpox infection (pooled and individually), in a population of GBMSM with anticipated high mpox risk and high prevalence of vaccination.

  2 weeks

Secondary Outcomes (4)

• Symptomatic prevalence

  2 weeks

• Mpox seropositivity

  2 weeks

• Characteristics

  2 weeks

• Characteristics of seropositivity

  2 weeks

Eligibility Criteria

• Gender Eligibility Details: Gay, bisexual, and other men who have sex with men
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants need to have been enrolled in an existing randomized clinical trial (NCT04762134)

You may qualify if:

• \- Participants need to have been enrolled in an existing randomized clinical trial (NCT04762134)

You may not qualify if:

• \- None

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

Unity Health Toronto

Toronto, Ontario, M5B 1T8, Canada

RECRUITING

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Central Study Contacts

Abby Li, MSc

CONTACT

416-360-4000; abby.li@unityhealth.to

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 9, 2024
• Study Start: April 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)