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

Study Overview
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Brief Summary
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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.

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

Conditions
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Monkeypox, HIV Coinfection

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PLHIV and Mpox coinfection<br> | Other: No intervention<br>* Study is retrospective data collection only<br>|
| HIV negative PrEP users with Mpox infection<br> | Other: No intervention<br>* Study is retrospective data collection only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Mpox lesions | Severity of lesions will be assessed by the peak number of lesions and peak number of sites. Skin lesion at peak severity score: Not presenting with skin lesions (0 skin lesions) Mild (<25 lesions) Moderate (25-99 skin lesions) Severe (100-250 skin lesions) Very severe (>250 skin lesions) Site of lesion will also be collected as part of the severity assessment: Genital lesions (defined as involvement of either vulva or vaginal mucosa or penis, pubic area) Ano-rectal/perianal lesions Oral mucosa (lips/gums/oral/pharynx) lesions Face Trunk (chest/torso/abdomen/back) Limbs (arms/forearms/legs/hands/feet) on the body. | From date of disease onset (first symptom) until date of peak number of lesions and sites recorded (up to 3 months) | 
| Clinical complications associated with Mpox | 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 The definition of a mental health condition will be that reported by the patient and recognized in the ICD-10 classification. | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death(up to 3 months) | 
| Percentage of hospitalisations | percentage of hospitalisations for clinical reasons only (i.e. not for precautionary measures or quarantine). | 1st May 2022 to 1st December 2023 | 
| Death |  | From date of disease onset (first symptom) until date of death related to Mpox (up to 3 months) | 
| Differences in the clinical manifestation of MPX in PLWHIV and PrEP users | Clinical manifestations will include: Severity and time to resolution of lesions, severity of disease, clinical complications, drug treatments, length of hospitalisations, and number of deaths. severe disease is defined as: Adults with severe clinical illness (e.g. National Early Warning Score [NEWS] 2 score of ≥5), which may include significant lower respiratory symptoms, confusion/encephalitis, and 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 to achieve symptomatic control Lesions associated with complications due to pain or swelling (e.g., constipation, urinary retention, inability to swallow) Confirmed infection, regardless of severity, in immunocompromised people, pregnant women, or children aged ≤16 years. | 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 MPX in PLWHIV by CD4 and VL. | Clinical manifestations will include: Severity and time to resolution of lesions, severity of disease, clinical complications, drug treatments, length of hospitalisations, and number of deaths. severe disease is defined as: Adults with severe clinical illness (e.g. National Early Warning Score [NEWS] 2 score of ≥5), which may include significant lower respiratory symptoms, confusion/encephalitis, and 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 to achieve symptomatic control Lesions associated with complications due to pain or swelling (e.g., constipation, urinary retention, inability to swallow) Confirmed infection, regardless of severity, in immunocompromised people, pregnant women, or children aged ≤16 years. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 1st May 2022 to 1st December 2023 | 
| Length of stay in hospital for inpatients treated for Mpox |  | From date of hospital admission for Mpox until date of hospital discharge (up to 3 months) | 
| Time to lesion resolution (if known) |  | From date of disease onset (first symptom) until date of lesion resolution (up to 3 months) | 
| Differences in the clinical manifestation of MPX in PLWHIV and PrEP users by co-morbidities. | Clinical manifestations will include: Severity and time to resolution of lesions, severity of disease, clinical complications, drug treatments, length of hospitalisations, and number of deaths. severe disease is defined as: Adults with severe clinical illness (e.g. National Early Warning Score [NEWS] 2 score of ≥5), which may include significant lower respiratory symptoms, confusion/encephalitis, and 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 to achieve symptomatic control Lesions associated with complications due to pain or swelling (e.g., constipation, urinary retention, inability to swallow) Confirmed infection, regardless of severity, in immunocompromised people, pregnant women, or children aged ≤16 years. | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death(up to 3 months) |