Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV

Completed

Conditions: Monkeypox
HIV Coinfection

Registration Number: NCT05965427

Lead Sponsor: NEAT ID Foundation

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2000

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severe Mpox Lesions	From date of disease onset (first symptom) until date of peak number of lesions and sites recorded (up to 3 months)	The number of participants with severe Mpox lesions. Severity of lesions will be assessed by the peak number of lesions and peak number of sites. Participants with ≥100 lesions at peak severity will be classified as having "severe lesions".
Clinical Complications Associated With Mpox	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)	Complications which will be collected are as follows: * Severe rectal and/or perianal pain (i.e. due to perianal/anal abscess, proctitis) * Tonsillitis and/or dysphagia * Secondary bacterial infection on affected skin * Urological complications (genital oedema, urinary retention) * Ocular involvement (conjunctivitis, corneal involvement, periorbital cellulitis) * Central nervous system involvement (encephalitis, meningitis, focal neurology signs) * Pneumonia/pulmonary abscess or necrotizing involvement * Myocarditis * Diarrhoea A composite outcome representing the presence of any specified clinical complication will be analysed. This composite outcome will be derived by identifying participants who have experienced one or more of the listed clinical complications during the observation period.
Number of Hospitalisation Events	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)	Number of hospitalisations for clinical reasons only (i.e. not for precautionary measures or quarantine).
Death	From date of disease onset (first symptom) until date of death related to Mpox (up to 3 months)	Number of any Mpox related mortality observed during the 3 month observation period
Differences in Mpox Lesion Severity (the Clinical Manifestation) in PLWHIV and PrEP Users	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)	The severity of lesions will be determined based on the peak/maximum severity score over the observation period. Lesion severity will be classified ordinally as follows: * Not presenting with skin lesions (0 skin lesions) * Mild (1-24 lesions) * Moderate (25-99 skin lesions) * Severe (100-250 skin lesions) * Very severe (\>250 skin lesions) Individuals with severe or very severe lesions (ie, ≥100 skin lesions) will be classified as having "severe lesions".
Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Site of Lesions	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)	Differences in the clinical manifestation of Mpox in PLWHIV and PrEP users by site of lesions. Site of lesions include genital (vulva/vaginal mucosa/penis/pubic area), ano-rectal/perianal, oral mucosa (lips/gums/oral/pharynx), face, trunk (chest/torso/abdomen/back) and limbs (arms/forearms/legs/hands/feet).
Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Severity Indicators	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)	Presence of severity indicators, below, was assessed in PLWHIV and PrEP Users with Mpox * Significant lower respiratory symptoms * Confusion/encephalitis, * Other complications (e.g. secondary bacterial infection, sepsis) * Widely disseminated lesions and very many in number (≥100) * Suspected infection of the cornea * Severe, refractory pain from lesions requiring hospitalisation * Lesions associated with complications due to pain or swelling
Differences in the NEWS2 Score ≥5 (Severity Indicator) in PLWHIV and PrEP Users With Mpox	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)	National Early Warning Score \[NEWS\] 2 score of ≥5 was reported for PLWHIV and PrEP Users with Mpox. NEWS2 is a summary score of six physiological parameters (respiratory rate, oxygen saturation, systolic blood pressure, heart rate, level of consciousness, temperature, and supplemental oxygen dependency) routinely recorded for inpatients. Each parameter is assigned a score between 0-3 based on how far it deviates from the normal range. These parameters are used to generate an aggregate severity score classified as low: aggregate score 0-4, low -medium/medium: score of 3 in any individual parameter/aggregate score 5-6,high: aggregate score 7 or more. Minimum scale score is 0, Maximum scale score is 20. A higher score indicates a greater clinical risk and worse outcome. A score ≥5 is a key threshold for urgent clinical review and signifies severe disease.
Differences in the Drug Treatments of Mpox in PLWHIV and PrEP Users	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)	Differences in the drug treatments (clinical manifestation) of Mpox in PLWHIV and PrEP users
Differences in the Drug Treatments for Complications of Mpox in PLWHIV and PrEP Users	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)	Differences in the drug treatments for complications of Mpox (secondary infections, bronchopneumonia, sepsis, encephalitis, and infection of the cornea with ensuing loss of vision) in PLWHIV and PrEP users
Differences in the First Symptom at Onset of Mpox in PLWHIV and PrEP Users	Mpox onset	First symptom at Mpox onset including lesion onset, prodromal symptoms (e.g., fever, myalgia, etc), rectal pain or other symptoms.
Mpox Transmission	Mpox onset	Differences between Mpox transmission characteristics in PLWHIV and PrEP users
Mpox Transmission Characteristics	Mpox onset	Differences in days between symptom onset and positive PCR test between PLWHIV with mpox and PrEP Users with mpox
Risk Factors for Mpox Outcomes	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)	Predicted risk factors (chronic kidney or liver disease, diabetes, lymphoma, AIDS defining condition, mental health condition, other comorbidities, and immunosuppression) will be analysed for presence or absence of severe mpox lesions (≥100 skin lesions)
Risk Factors for Mpox Outcomes for PLWHIV	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death(up to 3 months)	Risk factors (CD4 count) for severe mpox lesions (≥100 skin lesions) for PLWHIV

Secondary Outcome Measures

Name	Time	Method
Prevalence of Mpox During the Study Period	1st May 2022 to 1st December 2023	The number of mpox patients attending sites 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)
Length of Stay in Hospital	From date of hospital admission for Mpox until date of hospital discharge (up to 3 months)	The length of stay in hospital for inpatients treated for Mpox. In the case of multiple hospitalisations, the sum of the length of all stays will be analysed.
Time to Lesion Resolution (if Known)	From date of disease onset (first symptom) until date of lesion resolution (up to 3 months)	The estimate the time to lesion resolution for participants with at least one lesion during the observation period and with a known date of lesion resolution will be included.

Trial Locations

Locations (9): Hospital Clinic de Barcelona
🇪🇸
Barcelona, Spain
Hospital Universitari Germans Trias I Pujol
🇪🇸
Barcelona, Spain
Hospital San Carlos
🇪🇸
Madrid, Spain
Hospital Universitario La Paz
🇪🇸
Madrid, Spain
Hôpital Bichat Claude Bernard
🇫🇷
Paris, France
Hôpital Pitié-Salpêtrière
🇫🇷
Paris, France
Euroguidelines
🇵🇱
Warsaw, Poland
Hospital Universitari Vall d'Hebron
🇪🇸
Barcelona, Spain
Chelsea and Westminster Hospital
🇬🇧
London, United Kingdom
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain