MonkeypoxMASH1NCT05965427
Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
An observational study of Monkeypox and HIV Coinfection, run by NEAT ID Foundation at 9 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monkeypox, HIV Coinfection
- How many people
- 2,000 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 1 Dec 2023to 7 May 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People living with HIV who are currently sexually active and HIV negative high-risk Sexual Health Clinic attenders (PrEP users) with Mpox
Who may be able to join
- 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
Who cannot join
- MPX diagnosed based on clinical criteria only
- MPX diagnosis was within the last 90 days
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Spain5 sites
Hospital Clinic de Barcelona
Barcelona
Hospital Universitari Germans Trias I Pujol
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital San Carlos
Madrid
Hospital Universitario La Paz
Madrid
France2 sites
Hôpital Bichat Claude Bernard
Paris
Hôpital Pitié-Salpêtrière
Paris
About this study
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
- Being tested
- No intervention
- Medical subject headings
- Mpox, Monkeypox, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Study is retrospective data collection only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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".
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Mpox onset
Mpox Transmission
Differences between Mpox transmission characteristics in PLWHIV and PrEP users
Measured: Mpox onset
Mpox Transmission Characteristics
Differences in days between symptom onset and positive PCR test between PLWHIV with mpox and PrEP Users with mpox
Measured: 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)
Measured: 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
Measured: 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
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)
Measured: 1st May 2022 to 1st December 2023
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.
Measured: From date of hospital admission for Mpox until date of hospital discharge (up to 3 months)
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.
Measured: From date of disease onset (first symptom) until date of lesion resolution (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Dec 2023
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MonkeypoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- NEAT ID Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, PENTA Foundation
- Responsible party
- Sponsor
- Investigators
- Nicolo Girometti, MD, Principal investigator, Chelsea and Westminster NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965427
- Sponsor's protocol ID
- 606
- Acronym
- MASH1
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2023
- Last updated
- 13 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
- ClinicalTrials.gov ID
- NCT05965427
- Acronym / sponsor ID
- MASH1 / 606
- Conditions
- Monkeypox, HIV Coinfection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- NEAT ID FoundationUniversity, hospital or other
- Collaborators
- European Commission, PENTA Foundation
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Posted 13 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLWHIV and Mpox coinfection | – | Other: No interventionPeople 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. |
| HIV negative PrEP users with Mpox infection | – | Other: No interventionHIV 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with HIV who are currently sexually active and HIV negative high-risk Sexual Health Clinic attenders (PrEP users) with Mpox
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- MPX diagnosed based on clinical criteria only
- MPX diagnosis was within the last 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionStudy is retrospective data collection only | Other | HIV negative PrEP users with Mpox infection, PLWHIV and Mpox coinfection |
Primary outcome
Severe Mpox Lesions
Time frame: 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
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)
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
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)
Number of hospitalisations for clinical reasons only (i.e. not for precautionary measures or quarantine).
Death
Time frame: 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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
Time frame: Mpox onset
First symptom at Mpox onset including lesion onset, prodromal symptoms (e.g., fever, myalgia, etc), rectal pain or other symptoms.
Mpox Transmission
Time frame: Mpox onset
Differences between Mpox transmission characteristics in PLWHIV and PrEP users
Mpox Transmission Characteristics
Time frame: 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
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)
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
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)
Risk factors (CD4 count) for severe mpox lesions (≥100 skin lesions) for PLWHIV
3 secondary outcomes
Prevalence of Mpox During the Study Period
Time frame: 1st May 2022 to 1st December 2023
Length of Stay in Hospital
Time frame: From date of hospital admission for Mpox until date of hospital discharge (up to 3 months)
Time to Lesion Resolution (if Known)
Time frame: From date of disease onset (first symptom) until date of lesion resolution (up to 3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolo Girometti, MD principal investigator
Chelsea and Westminster NHS Trust
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monkeypox and HIV Coinfection, run by NEAT ID Foundation at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, France, Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Mpox Lesions (time frame: From date of disease onset (first symptom) until date of peak number of lesions and sites recorded (up to 3 months)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.