Understanding the impact of monkeypox on HIV-negative and HIV-positive individuals
Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
This study looks at how monkeypox affects people with HIV compared to those who are HIV-negative but taking PrEP to see what factors might influence their outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NEAT ID Foundation Academic / other |
| Locations | 5 sites (Paris and 4 other locations) |
| Trial ID | NCT05965427 on ClinicalTrials.gov |
What this trial studies
This observational study collects data to compare the outcomes of monkeypox (Mpox) in individuals living with HIV and those who are HIV-negative but on pre-exposure prophylaxis (PrEP). It aims to identify risk factors associated with specific outcomes of Mpox. Participants must have a confirmed Mpox diagnosis from PCR testing and be at least 18 years old. The study focuses on cases diagnosed more than 90 days prior to data collection.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older who have been diagnosed with monkeypox more than 90 days prior and either live with HIV or are HIV-negative and on PrEP.
Not a fit: Patients diagnosed with monkeypox within the last 90 days or those whose diagnosis was based solely on clinical criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the risk factors and outcomes of monkeypox, potentially improving management strategies for affected individuals.
How similar studies have performed: While this study focuses on a specific population, similar observational studies have successfully identified risk factors and outcomes for infectious diseases, suggesting potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of MPX was more than 90 days prior to data collection * Confirmed MPX infection by documented PCR testing of lesions between 1st May 2022 to 1st December 2023 * At least 18 years of age * Cases (PLWHIV + MPX) i) Documented HIV-1 infection * Cases (PrEP users + MPX) i) Attended a clinic to receive PrEP Exclusion Criteria: * MPX diagnosed based on clinical criteria only * MPX diagnosis was within the last 90 days
Where this trial is running
Paris and 4 other locations
- Hôpital Bichat Claude Bernard — Paris, France (Recruiting)
- Hôpital Pitié-Salpêtrière — Paris, France (Recruiting)
- Euroguidelines — Warsaw, Poland (Recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
- Chelsea and Westminster Hospital — London, United Kingdom (Active_not_recruiting)
Study contacts
- Principal investigator: Nicolo Girometti, MD — Chelsea and Westminster NHS Trust
- Study coordinator: Debbie Roberts, PhD
- Email: debbie.roberts@rokcservices.com
- Phone: 07956761151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.