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

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• Mpox, Monkeypox 72
• HIV Infections 4,734

Mpox, Monkeypox

72 studies on the registry are indexed under Mpox, Monkeypox; 30 are open to participants now.

This study's enrollment of 2,000 is above the median of 224 across 34 observational studies indexed under Mpox, Monkeypox.

Lead sponsor

NEAT ID Foundation is the lead sponsor of 7 studies on the registry; none are open to participants now.

Study population

Groups and cohorts

• PLWHIV and Mpox coinfection

  People living with HIV(PLWHIV) who are at least 18 years of age, with confirmed Mpox infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.

  Other: No intervention

• HIV negative PrEP users with Mpox infection

  HIV negative PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed Mpox infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.

  Other: No intervention

Interventions

• OtherNo intervention

  Study is retrospective data collection only

Primary outcomes

1. Severe Mpox Lesions

   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".

   Time frame: From date of disease onset (first symptom) until date of peak number of lesions and sites recorded (up to 3 months)

2. 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 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.

   Time frame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)

3. Number of Hospitalisation Events

   Number of hospitalisations for clinical reasons only (i.e. not for precautionary measures or quarantine).

   Time frame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)

4. Death

   Number of any Mpox related mortality observed during the 3 month observation period

   Time frame: From date of disease onset (first symptom) until date of death related to Mpox (up to 3 months)

5. Differences in Mpox Lesion Severity (the Clinical Manifestation) in PLWHIV and PrEP Users

   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".

   Time frame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)

6. Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Site of Lesions

   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).

   Time frame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)

7. Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Severity Indicators

   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

   Time frame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)

8. Differences in the NEWS2 Score ≥5 (Severity Indicator) in PLWHIV and PrEP Users With Mpox

   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.

   Time frame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)

9. Differences in the Drug Treatments of Mpox in PLWHIV and PrEP Users

   Differences in the drug treatments (clinical manifestation) of Mpox in PLWHIV and PrEP users

   Time frame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)

10. Differences in the Drug Treatments for Complications of Mpox in PLWHIV and PrEP Users

    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

    Time frame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)

11. Differences in the First Symptom at Onset of Mpox in PLWHIV and PrEP Users

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

    Time frame: Mpox onset

12. Mpox Transmission

    Differences between Mpox transmission characteristics in PLWHIV and PrEP users

    Time frame: Mpox onset

13. Mpox Transmission Characteristics

    Differences in days between symptom onset and positive PCR test between PLWHIV with mpox and PrEP Users with mpox

    Time frame: Mpox onset

14. Risk Factors for Mpox Outcomes

    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)

    Time frame: From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months)

15. Risk Factors for Mpox Outcomes for PLWHIV

    Risk factors (CD4 count) for severe mpox lesions (≥100 skin lesions) for PLWHIV

    Time frame: 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

1. Prevalence of Mpox During the Study Period

   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)

   Time frame: 1st May 2022 to 1st December 2023

2. Length of Stay in Hospital

   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 frame: From date of hospital admission for Mpox until date of hospital discharge (up to 3 months)

3. Time to Lesion Resolution (if Known)

   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.

   Time frame: From date of disease onset (first symptom) until date of lesion resolution (up to 3 months)

Baseline characteristics

4 further baseline measures are reported on the registry.

Study documents

• Protocol and statistical analysis plan ↗ · Nov 1, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided