xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05965427</url>
    </required_header>
    <id_info>
      <org_study_id>606</org_study_id>
      <nct_id>NCT05965427</nct_id>
    </id_info>
    <brief_title>Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV</brief_title>
    <acronym>MASH 1</acronym>
    <official_title>Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NEAT ID Foundation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>VERDI Consortium</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>European Commission</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>PENTA Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>NEAT ID Foundation</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This data collection study aims to describe and compare the outcomes of Mpox on people living&#xD;
        with HIV (PLHIV) and HIV-negative individuals who are on pre-exposure prophylaxis (PrEP). The&#xD;
        study also aims to identify risk factors for specific Mpox outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Severity of Mpox lesions</measure>
      <time_frame>From date of disease onset (first symptom) until date of peak number of lesions and sites recorded (up to 3 months)</time_frame>
      <description>Severity of lesions will be assessed by the peak number of lesions and peak number of sites.&#xD;
  Skin lesion at peak severity score:&#xD;
  Not presenting with skin lesions (0 skin lesions)&#xD;
  Mild (&lt;25 lesions)&#xD;
  Moderate (25-99 skin lesions)&#xD;
  Severe (100-250 skin lesions)&#xD;
  Very severe (&gt;250 skin lesions)&#xD;
  Site of lesion will also be collected as part of the severity assessment:&#xD;
  Genital lesions (defined as involvement of either vulva or vaginal mucosa or penis, pubic area)&#xD;
  Ano-rectal/perianal lesions&#xD;
  Oral mucosa (lips/gums/oral/pharynx) lesions&#xD;
  Face&#xD;
  Trunk (chest/torso/abdomen/back)&#xD;
  Limbs (arms/forearms/legs/hands/feet) on the body.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical complications associated with Mpox</measure>
      <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)</time_frame>
      <description>Complications which will be collected are as follows:&#xD;
  Severe rectal and/or perianal pain (i.e. due to perianal/anal abscess, proctitis)&#xD;
  Tonsillitis and/or dysphagia&#xD;
  Secondary bacterial infection on affected skin&#xD;
  Urological complications (genital oedema, urinary retention)&#xD;
  Ocular involvement (conjunctivitis, corneal involvement, periorbital cellulitis)&#xD;
  Central nervous system involvement (encephalitis, meningitis, focal neurology signs)&#xD;
  Pneumonia/pulmonary abscess or necrotizing involvement&#xD;
  Myocarditis&#xD;
  Diarrhoea&#xD;
  The definition of a mental health condition will be that reported by the patient and recognized in the ICD-10 classification.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of hospitalisations</measure>
      <time_frame>1st May 2022 to 1st December 2023</time_frame>
      <description>percentage of hospitalisations for clinical reasons only (i.e. not for precautionary measures or quarantine).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Death</measure>
      <time_frame>From date of disease onset (first symptom) until date of death related to Mpox (up to 3 months)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Differences in the clinical manifestation of MPX in PLWHIV and PrEP users</measure>
      <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)</time_frame>
      <description>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.&#xD;
  severe disease is defined as:&#xD;
  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)&#xD;
  Widely disseminated lesions and very many in number (≥100)&#xD;
  Suspected infection of the cornea&#xD;
  Severe, refractory pain from lesions requiring hospitalisation to achieve symptomatic control&#xD;
  Lesions associated with complications due to pain or swelling (e.g., constipation, urinary retention, inability to swallow)&#xD;
  Confirmed infection, regardless of severity, in immunocompromised people, pregnant women, or children aged ≤16 years.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Differences in the clinical manifestation of MPX in PLWHIV by CD4 and VL.</measure>
      <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)</time_frame>
      <description>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.&#xD;
  severe disease is defined as:&#xD;
  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)&#xD;
  Widely disseminated lesions and very many in number (≥100)&#xD;
  Suspected infection of the cornea&#xD;
  Severe, refractory pain from lesions requiring hospitalisation to achieve symptomatic control&#xD;
  Lesions associated with complications due to pain or swelling (e.g., constipation, urinary retention, inability to swallow)&#xD;
  Confirmed infection, regardless of severity, in immunocompromised people, pregnant women, or children aged ≤16 years.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>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)</measure>
      <time_frame>1st May 2022 to 1st December 2023</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay in hospital for inpatients treated for Mpox</measure>
      <time_frame>From date of hospital admission for Mpox until date of hospital discharge (up to 3 months)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to lesion resolution (if known)</measure>
      <time_frame>From date of disease onset (first symptom) until date of lesion resolution (up to 3 months)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in the clinical manifestation of MPX in PLWHIV and PrEP users by co-morbidities.</measure>
      <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)</time_frame>
      <description>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.&#xD;
  severe disease is defined as:&#xD;
  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)&#xD;
  Widely disseminated lesions and very many in number (≥100)&#xD;
  Suspected infection of the cornea&#xD;
  Severe, refractory pain from lesions requiring hospitalisation to achieve symptomatic control&#xD;
  Lesions associated with complications due to pain or swelling (e.g., constipation, urinary retention, inability to swallow)&#xD;
  Confirmed infection, regardless of severity, in immunocompromised people, pregnant women, or children aged ≤16 years.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Monkeypox</condition>
    <condition>HIV Coinfection</condition>
    <arm_group>
      <arm_group_label>PLHIV and Mpox coinfection</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>HIV negative PrEP users with Mpox infection</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>Study is retrospective data collection only</description>
      <arm_group_label>HIV negative PrEP users with Mpox infection</arm_group_label>
      <arm_group_label>PLHIV and Mpox coinfection</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          People living with HIV who are currently sexually active and HIV negative high-risk Sexual&#xD;
          Health Clinic attenders (PrEP users) with Mpox&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of MPX was more than 90 days prior to data collection&#xD;
  &#xD;
            -  Confirmed MPX infection by documented PCR testing of lesions between 1st May 2022 to&#xD;
               1st December 2023&#xD;
  &#xD;
            -  At least 18 years of age&#xD;
  &#xD;
            -  Cases (PLWHIV + MPX) i) Documented HIV-1 infection&#xD;
  &#xD;
            -  Cases (PrEP users + MPX) i) Attended a clinic to receive PrEP&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  MPX diagnosed based on clinical criteria only&#xD;
  &#xD;
            -  MPX diagnosis was within the last 90 days&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nicolo Girometti, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chelsea and Westminster NHS Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Debbie Roberts, PhD</last_name>
      <phone>07956761151</phone>
      <email>debbie.roberts@rokcservices.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>MASH 1 project manager</last_name>
      <phone>+44 203 859 7747</phone>
      <email>mash1@rokcservices.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coinfection</mesh_term>
      <mesh_term>Monkeypox</mesh_term>
      <mesh_term>HIV Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05965427
  org study id: 606
  nct id: NCT05965427
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Cohort
  time perspective: Retrospective
  measure: Severity of 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)
  description: 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.
  measure: 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)
  description: 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.
  measure: Percentage of hospitalisations
  time frame: 1st May 2022 to 1st December 2023
  description: percentage of hospitalisations for clinical reasons only (i.e. not for precautionary measures or quarantine).
  measure: Death
  time frame: From date of disease onset (first symptom) until date of death related to Mpox (up to 3 months)
  measure: Differences in the clinical manifestation of MPX 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)
  description: 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.
  measure: Differences in the clinical manifestation of MPX in PLWHIV by CD4 and VL.
  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)
  description: 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.
  measure: 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)
  time frame: 1st May 2022 to 1st December 2023
  measure: Length of stay in hospital for inpatients treated for Mpox
  time frame: From date of hospital admission for Mpox until date of hospital discharge (up to 3 months)
  measure: Time to lesion resolution (if known)
  time frame: From date of disease onset (first symptom) until date of lesion resolution (up to 3 months)
  measure: Differences in the clinical manifestation of MPX in PLWHIV and PrEP users by co-morbidities.
  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)
  description: 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.
  arm group label: PLHIV and Mpox coinfection
  arm group label: HIV negative PrEP users with Mpox infection
  intervention type: Other
  intervention name: No intervention
  description: Study is retrospective data collection only
  arm group label: HIV negative PrEP users with Mpox infection
  arm group label: PLHIV and Mpox coinfection
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nicolo Girometti, MD
  role: Principal Investigator
  affiliation: Chelsea and Westminster NHS Trust
  last name: Debbie Roberts, PhD
  phone: 07956761151
  email: debbie.roberts@rokcservices.com
  last name: MASH 1 project manager
  phone: +44 203 859 7747
  email: mash1@rokcservices.com
  responsible party type: Sponsor
  mesh term: Coinfection
  mesh term: Monkeypox
  mesh term: HIV Infections
  sharing ipd: Undecided