Clinical trial NCT05965427: Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
Official title: Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Monkeypox
HIV Coinfection
Lead sponsor: NEAT ID Foundation
Sponsor class: OTHER
Collaborators: name: VERDI Consortium
name: European Commission
name: PENTA Foundation
First posted: 2023-07-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People living with HIV who are currently sexually active and HIV negative high-risk Sexual Health Clinic attenders (PrEP users) with Mpox

Brief summary: This data collection study aims to describe and compare the outcomes of Mpox on people living with HIV (PLHIV) and HIV-negative individuals who are on pre-exposure prophylaxis (PrEP). The study also aims to identify risk factors for specific Mpox outcomes.


Eligibility 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

Primary outcomes:
measure: Severity of Mpox lesions
timeFrame: From date of disease onset (first symptom) until date of peak number of lesions and sites recorded (up to 3 months)
measure: Clinical complications associated with Mpox
timeFrame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death(up to 3 months)
measure: Percentage of hospitalisations
timeFrame: 1st May 2022 to 1st December 2023
measure: Death
timeFrame: From date of disease onset (first symptom) until date of death related to Mpox (up to 3 months)
measure: Differences in the clinical manifestation of MPX in PLWHIV and PrEP users
timeFrame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death(up to 3 months)
measure: Differences in the clinical manifestation of MPX in PLWHIV by CD4 and VL.
timeFrame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death(up to 3 months)
Secondary outcomes:
measure: Number of MPX patients attending as a percentage of total number of patients the sites have seen over a set period of time (from first Mpox patient to last Mpox patient)
timeFrame: 1st May 2022 to 1st December 2023
measure: Length of stay in hospital for inpatients treated for Mpox
timeFrame: From date of hospital admission for Mpox until date of hospital discharge (up to 3 months)
measure: Time to lesion resolution (if known)
timeFrame: From date of disease onset (first symptom) until date of lesion resolution (up to 3 months)
measure: Differences in the clinical manifestation of MPX in PLWHIV and PrEP users by co-morbidities.
timeFrame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death(up to 3 months)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat Claude Bernard
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Warsaw
country: Poland
facility: Euroguidelines
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: Chelsea and Westminster NHS Trust
name: Nicolo Girometti, MD
role: PRINCIPAL_INVESTIGATOR
References: