Looking for Asymptomatic Mpox in a Population at High Risk

Recruiting

• Conditions: Mpox (Monkeypox)

• Registration Number: NCT06353737
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-01
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-09
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asymptomatic prevalence	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Mpox seropositivity	2 weeks	To determine the prevalence of mpox seropositivity (both for total antibody and for neutralizing antibody) in the study sample
Symptomatic prevalence	2 weeks	To determine the prevalence of symptomatic mpox infection in the study sample
Characteristics	2 weeks	To identify clinical and demographic characteristics associated with asymptomatic and/or paucisymptomatic infection in the study sample
Characteristics of seropositivity	2 weeks	To identify clinical and demographic characteristics associated with mpox seropositivity in the study sample

Trial Locations

Locations (1)

Unity Health Toronto; 🇨🇦 Toronto, Ontario, Canada