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

NCT05965427 | Completed Results

• 1 other identifier: 606
• Study Type: observational
• Target: 2,000
• Locations: 4 countries
• Sites: 9

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.

Conditions

Monkeypox; HIV Coinfection

Outcome Measures

Primary Outcomes (15)

• 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".

  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 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.

  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 Hospitalisation Events

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

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

• Death

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

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

• 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".

  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

  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).

  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 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

  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 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.

  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 of Mpox in PLWHIV and PrEP Users

  Differences in the drug treatments (clinical manifestation) 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 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

  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 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.

  Mpox onset

• Mpox Transmission

  Differences between Mpox transmission characteristics in PLWHIV and PrEP users

  Mpox onset

• Mpox Transmission Characteristics

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

  Mpox onset

• 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)

  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 for Mpox Outcomes for PLWHIV

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

Secondary Outcomes (3)

• Prevalence of Mpox During the Study Period

  1st May 2022 to 1st December 2023

• Length of Stay in Hospital

  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)

Study Arms (2)

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

No intervention OTHER

Study is retrospective data collection only

HIV negative PrEP users with Mpox infection; PLWHIV and Mpox coinfection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• MPX diagnosed based on clinical criteria only
• MPX diagnosis was within the last 90 days

Sponsors & Collaborators

• NEAT ID Foundation: lead
• European Commission: collaborator
• PENTA Foundation: collaborator

Study Sites (9)

Hôpital Bichat Claude Bernard

Paris, France

Location

Hôpital Pitié-Salpêtrière

Paris, France

Location

Euroguidelines

Warsaw, Poland

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital Universitari Germans Trias I Pujol

Barcelona, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital San Carlos

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Chelsea and Westminster Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Mpox, Monkeypox; HIV Infections

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: MASH1 Clinical Project Manager
• Organization: Research Organization (KC) Ltd

mash1@rokcservices.com

+44 (0) 7494 795 982

Study Officials

• Nicolo Girometti, MD

  Chelsea and Westminster NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 28, 2023
• Study Start: December 1, 2023
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-07

Locations

FR (2); GB (1); ES (5); PL (1)