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

Severe Mpox Lesions

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Mpox onset

First symptom at Mpox onset including lesion onset, prodromal symptoms (e.g., fever, myalgia, etc), rectal pain or other symptoms.

Mpox Transmission

时间窗: Mpox onset

Differences between Mpox transmission characteristics in PLWHIV and PrEP users

Mpox Transmission Characteristics

时间窗: 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

时间窗: 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

时间窗: 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