Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT05965427
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2023-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045908', 'term': 'Mpox, Monkeypox'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018419', 'term': 'Primate Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}, {'id': 'D012376', 'term': 'Rodent Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mash1@rokcservices.com', 'phone': '+44 (0) 7494 795 982', 'title': 'MASH1 Clinical Project Manager', 'organization': 'Research Organization (KC) Ltd'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From date of disease onset/first symptom, D0, until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) D90', 'description': 'Adverse events were not assessed for this study, only deaths and hospitalisations were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 946, 'otherNumAffected': 0, 'seriousNumAtRisk': 946, 'deathsNumAffected': 0, 'seriousNumAffected': 57}, {'id': 'EG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1054, 'otherNumAffected': 0, 'seriousNumAtRisk': 1054, 'deathsNumAffected': 0, 'seriousNumAffected': 38}], 'seriousEvents': [{'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 946, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 1054, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severe Mpox Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'OG000'}, {'value': '906', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of disease onset (first symptom) until date of peak number of lesions and sites recorded (up to 3 months)', 'description': '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".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Skin lesion severity could not be analysed for all participants as the number of lesions were not available due to the retrospective data collection nature of this study.'}, {'type': 'PRIMARY', 'title': 'Clinical Complications Associated With Mpox', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'title': 'Severe rectal and/or perianal pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1049', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}]}, {'title': 'Tonsilitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1050', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Dysphagia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Secondary bacterial infection on affected skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '1049', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'Urological complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Ocular involvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Central nervous system involvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia/pulmonary abscess or necrotising involvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Myocarditis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any of the specified clinical complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '321', 'groupId': 'OG000'}, {'value': '424', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical analysis of "Any of the specified clinical complications" measure', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '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:\n\n* Severe rectal and/or perianal pain (i.e. due to perianal/anal abscess, proctitis)\n* Tonsillitis and/or dysphagia\n* Secondary bacterial infection on affected skin\n* Urological complications (genital oedema, urinary retention)\n* Ocular involvement (conjunctivitis, corneal involvement, periorbital cellulitis)\n* Central nervous system involvement (encephalitis, meningitis, focal neurology signs)\n* Pneumonia/pulmonary abscess or necrotizing involvement\n* Myocarditis\n* Diarrhoea\n\nA 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical complication data was not available for available for all participants due to the retrospective data collection nature of this study.'}, {'type': 'PRIMARY', 'title': 'Number of Hospitalisation Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'OG000'}, {'value': '1054', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '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': 'Number of hospitalisations for clinical reasons only (i.e. not for precautionary measures or quarantine).', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'OG000'}, {'value': '1054', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of disease onset (first symptom) until date of death related to Mpox (up to 3 months)', 'description': 'Number of any Mpox related mortality observed during the 3 month observation period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Differences in Mpox Lesion Severity (the Clinical Manifestation) in PLWHIV and PrEP Users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'OG000'}, {'value': '1054', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'title': 'Not presenting with skin lesions', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '676', 'groupId': 'OG000'}, {'value': '805', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Very severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unknown number of lesions', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical analysis relates to "not presenting with skin lesions" measure', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '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': '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:\n\n* Not presenting with skin lesions (0 skin lesions)\n* Mild (1-24 lesions)\n* Moderate (25-99 skin lesions)\n* Severe (100-250 skin lesions)\n* Very severe (\\>250 skin lesions) Individuals with severe or very severe lesions (ie, ≥100 skin lesions) will be classified as having "severe lesions".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Site of Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '896', 'groupId': 'OG000'}, {'value': '976', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'title': 'Genital (vulva/vaginal mucosa/penis/pubic area)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '896', 'groupId': 'OG000'}, {'value': '976', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '425', 'groupId': 'OG000'}, {'value': '565', 'groupId': 'OG001'}]}]}, {'title': 'Ano-rectal/perianal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'OG000'}, {'value': '973', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '454', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}]}, {'title': 'Oral mucosa (lips/gums/oral/pharynx)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '889', 'groupId': 'OG000'}, {'value': '972', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}, {'title': 'Face', 'denoms': [{'units': 'Participants', 'counts': [{'value': '890', 'groupId': 'OG000'}, {'value': '971', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '267', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}]}, {'title': 'Trunk (chest/torso/abdomen/back)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '889', 'groupId': 'OG000'}, {'value': '970', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '353', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}]}, {'title': 'Limbs (arms/forearms/legs/hands/feet)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '970', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '416', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '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': '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).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Site of lesion data was not available for all participants due to the retrospective data collection in this study.'}, {'type': 'PRIMARY', 'title': 'Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Severity Indicators', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1052', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'title': 'Significant lower respiratory symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Confusion/Encephalitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other complications (eg, secondary bacterial infection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '1049', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}, {'title': 'Widely disseminated lesions and very many in number', 'denoms': [{'units': 'Participants', 'counts': [{'value': '933', 'groupId': 'OG000'}, {'value': '1045', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Suspected infection of the cornea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Severe, refractory pain from lesions requiring hospitalisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '938', 'groupId': 'OG000'}, {'value': '1052', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Lesions associated with complications due to pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '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': 'Presence of severity indicators, below, was assessed in PLWHIV and PrEP Users with Mpox\n\n* Significant lower respiratory symptoms\n* Confusion/encephalitis,\n* Other complications (e.g. secondary bacterial infection, sepsis)\n* Widely disseminated lesions and very many in number (≥100)\n* Suspected infection of the cornea\n* Severe, refractory pain from lesions requiring hospitalisation\n* Lesions associated with complications due to pain or swelling', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Severity indicators were not available for all participants due to the retrospective nature of this data collection study.'}, {'type': 'PRIMARY', 'title': 'Differences in the NEWS2 Score ≥5 (Severity Indicator) in PLWHIV and PrEP Users With Mpox', 'denoms': [{'units': 'Participants', 'counts': [{'value': '630', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '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': 'National Early Warning Score \\[NEWS\\] 2 score of ≥5 was reported for PLWHIV and PrEP Users with Mpox.\n\nNEWS2 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.\n\nA 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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'NEWS2 score was not available for all participants due to the retrospective nature of this data collection study.'}, {'type': 'PRIMARY', 'title': 'Differences in the Drug Treatments of Mpox in PLWHIV and PrEP Users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '942', 'groupId': 'OG000'}, {'value': '1044', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'title': 'Tecovirimat', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Other antimicrobials or antivirals', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any drug treatment for mpox', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.114', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical analysis relates to "any drug treatment for mpox" measure', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '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': 'Differences in the drug treatments (clinical manifestation) of Mpox in PLWHIV and PrEP users', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Drug treatment for mpox data was not available for all participants. Due to the retrospective nature of this data collection study, only available data was collected for analysis.'}, {'type': 'PRIMARY', 'title': 'Differences in the Drug Treatments for Complications of Mpox in PLWHIV and PrEP Users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '942', 'groupId': 'OG000'}, {'value': '1043', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'title': 'Any drug for complications', 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}]}, {'title': 'Antibiotics', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}]}, {'title': 'Analgesia', 'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}]}]}, {'title': 'Laxatives', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical analysis relates to "any drug for complications" measure', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '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': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Drug treatment for Mpox complications data was not available for all participants. Due to the retrospective nature of this data collection study, only available data was collected for analysis.'}, {'type': 'PRIMARY', 'title': 'Differences in the First Symptom at Onset of Mpox in PLWHIV and PrEP Users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'OG000'}, {'value': '1054', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'title': 'Lesion onset', 'categories': [{'measurements': [{'value': '322', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}]}, {'title': 'Prodromal symptoms (eg, fever, myalgia, etc)', 'categories': [{'measurements': [{'value': '425', 'groupId': 'OG000'}, {'value': '327', 'groupId': 'OG001'}]}]}, {'title': 'Rectal pain', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Statistical analysis relates to "lesion onset" measure'}], 'paramType': 'NUMBER', 'timeFrame': 'Mpox onset', 'description': 'First symptom at Mpox onset including lesion onset, prodromal symptoms (e.g., fever, myalgia, etc), rectal pain or other symptoms.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'First symptom at Mpox onset was not available/unknown for all participants due to the retrospective data collection in this study.'}, {'type': 'PRIMARY', 'title': 'Mpox Transmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'OG000'}, {'value': '1054', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'title': 'Recent travel to/living in endemic country or country with outbreak', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}]}, {'title': 'No recent travel to/living in endemic country or country with outbreak', 'categories': [{'measurements': [{'value': '777', 'groupId': 'OG000'}, {'value': '701', 'groupId': 'OG001'}]}]}, {'title': 'Unknown recent travel to/living in endemic country or country with outbreak', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Contact with suspected, probable, or confirmed case', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}, {'title': 'No contact with suspected, probable, or confirmed case', 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}, {'title': 'Unknown contact with suspected, probable, or confirmed case', 'categories': [{'measurements': [{'value': '562', 'groupId': 'OG000'}, {'value': '775', 'groupId': 'OG001'}]}]}, {'title': 'Contact with infected animal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No contact with infected animal', 'categories': [{'measurements': [{'value': '580', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}]}, {'title': 'Unknown contact with infected animal', 'categories': [{'measurements': [{'value': '366', 'groupId': 'OG000'}, {'value': '652', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Mpox onset', 'description': 'Differences between Mpox transmission characteristics in PLWHIV and PrEP users', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mpox Transmission Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '850', 'groupId': 'OG000'}, {'value': '940', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '9'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Mpox onset', 'description': 'Differences in days between symptom onset and positive PCR test between PLWHIV with mpox and PrEP Users with mpox', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Days between symptom onset and positive PCR test data was not available for all participants due to the retrospective nature of this data collection study.'}, {'type': 'PRIMARY', 'title': 'Risk Factors for Mpox Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1672', 'groupId': 'OG000'}, {'value': '1672', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants in Risk Predictor Category With Severe Mpox Lesions Present', 'description': 'PLWHIV and PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023'}, {'id': 'OG001', 'title': 'All Participants in Risk Predictor Category With Severe Mpox Lesions Absent', 'description': 'PLWHIV and PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023'}], 'classes': [{'title': 'Patient group -PLWHIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'OG000'}, {'value': '766', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '760', 'groupId': 'OG001'}]}]}, {'title': 'Patient group -PrEP users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '906', 'groupId': 'OG000'}, {'value': '906', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '904', 'groupId': 'OG001'}]}]}, {'title': 'Age <30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}]}, {'title': 'Age 30-40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '796', 'groupId': 'OG000'}, {'value': '796', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '790', 'groupId': 'OG001'}]}]}, {'title': 'Age > 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}, {'value': '607', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '605', 'groupId': 'OG001'}]}]}, {'title': 'Chronic kidney or liver disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'AIDS defining condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}]}, {'title': 'Mental health condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Immunosuppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Multiple sexual partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1090', 'groupId': 'OG000'}, {'value': '1090', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1088', 'groupId': 'OG001'}]}]}, {'title': 'Orthopoxvirus vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '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': '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)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Severe lesion endpoint data was not available for all participants due to the retrospective nature of this data collection study. No events occurred in some groups and were therefore not included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Risk Factors for Mpox Outcomes for PLWHIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '649', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV With CD4 Count and Severe Mpox Lesions Present', 'description': 'PLWHIV who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023'}, {'id': 'OG001', 'title': 'PLWHIV With CD4 Count and Severe Mpox Lesions Absent', 'description': 'PLWHIV who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023'}], 'classes': [{'categories': [{'measurements': [{'value': '680', 'spread': '513', 'groupId': 'OG000'}, {'value': '683', 'spread': '338', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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': 'Risk factors (CD4 count) for severe mpox lesions (≥100 skin lesions) for PLWHIV', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CD4 data was not available for all participants due to the retrospective nature of this data collection study.'}, {'type': 'SECONDARY', 'title': 'Prevalence of Mpox During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468845', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Total number of patients evaluated at clinical sites 1st May 2022 to 1st December 2023.'}], 'classes': [{'title': 'Chelsea and Westminster', 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.32', 'upperLimit': '0.36'}]}]}, {'title': 'Hospital Germans Trias i Pujol', 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '0.94'}]}]}, {'title': 'Hospital San Carlos', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '1.07'}]}]}, {'title': "Hospital Vall d'Hebron", 'categories': [{'measurements': [{'value': '2.90', 'groupId': 'OG000', 'lowerLimit': '2.63', 'upperLimit': '3.19'}]}]}, {'title': 'Hospital La Paz', 'categories': [{'measurements': [{'value': '1.54', 'groupId': 'OG000', 'lowerLimit': '1.37', 'upperLimit': '1.73'}]}]}, {'title': 'Hospital Bichat Claude-Bernard', 'categories': [{'measurements': [{'value': '3.07', 'groupId': 'OG000', 'lowerLimit': '2.90', 'upperLimit': '3.26'}]}]}, {'title': 'Hospital Pitié Salpêtrière', 'categories': [{'measurements': [{'value': '1.48', 'groupId': 'OG000', 'lowerLimit': '1.33', 'upperLimit': '1.64'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1st May 2022 to 1st December 2023', 'description': '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)', 'unitOfMeasure': 'percentage of mpox cases', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patient data was not available at 2 sites, Hospital Clinic Barcelona and EECE Warsaw, and are excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Length of Stay in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of hospital admission for Mpox until date of hospital discharge (up to 3 months)', 'description': '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.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Lesion Resolution (if Known)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'People living with HIV (PLWHIV) who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}, {'id': 'OG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed MPX infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '24'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of disease onset (first symptom) until date of lesion resolution (up to 3 months)', 'description': '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.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PLHIV and Mpox Coinfection', 'description': 'No intervention: Study is retrospective data collection only'}, {'id': 'FG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'No intervention: Study is retrospective data collection only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '946'}, {'groupId': 'FG001', 'numSubjects': '1054'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '946'}, {'groupId': 'FG001', 'numSubjects': '1054'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Deidentified real-world retrospective, routine data was collected PLWHIV (people living with HIV) who are currently sexually active and HIV negative high-risk Sexual Health Clinic attenders (PrEP users) with Mpox at clinical sites in the UK and Europe.', 'preAssignmentDetails': 'This is observational retrospective cohort data collection study. Data was collected from adult PrEP users and PLWHIV with confirmed mpox infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023, at least 90 days prior to data collection.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PLWHIV and Mpox Coinfection', 'description': 'No intervention: Study is retrospective data collection only'}, {'id': 'BG001', 'title': 'HIV Negative PrEP Users With Mpox Infection', 'description': 'No intervention: Study is retrospective data collection only'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age Category : <30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG002'}]}]}, {'title': 'Age Category : 30-40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '433', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '954', 'groupId': 'BG002'}]}]}, {'title': 'Age Category : >40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '405', 'groupId': 'BG000'}, {'value': '324', 'groupId': 'BG001'}, {'value': '729', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex/Gender : Male sex at birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}]}, {'title': 'Sex/Gender : Male gender identity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '922', 'groupId': 'BG000'}, {'value': '1040', 'groupId': 'BG001'}, {'value': '1962', 'groupId': 'BG002'}]}]}, {'title': 'Sex/Gender : Female gender identity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Sex/Gender : Non-binary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '282', 'groupId': 'BG000'}, {'value': '445', 'groupId': 'BG001'}, {'value': '727', 'groupId': 'BG002'}]}]}, {'title': 'Mixed or multiple', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Not stated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '557', 'groupId': 'BG000'}, {'value': '465', 'groupId': 'BG001'}, {'value': '1022', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '771', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '525', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '883', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Orthopoxvirus vaccination', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'BG000'}, {'value': '431', 'groupId': 'BG001'}, {'value': '993', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The number of participants who had previously received an Orthopoxvirus vaccine', 'unitOfMeasure': 'Participants', 'populationDescription': 'Vaccination history was not available for all participants.'}, {'title': 'Comorbidities', 'classes': [{'title': 'Liver disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '934', 'groupId': 'BG000'}, {'value': '1048', 'groupId': 'BG001'}, {'value': '1982', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Chronic kidney disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '931', 'groupId': 'BG000'}, {'value': '1048', 'groupId': 'BG001'}, {'value': '1979', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '929', 'groupId': 'BG000'}, {'value': '1048', 'groupId': 'BG001'}, {'value': '1977', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Lymphoma or leukaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '934', 'groupId': 'BG000'}, {'value': '1048', 'groupId': 'BG001'}, {'value': '1982', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'AIDS defining condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '935', 'groupId': 'BG000'}, {'value': '1049', 'groupId': 'BG001'}, {'value': '1984', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '316', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}]}, {'title': 'Mental health condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '928', 'groupId': 'BG000'}, {'value': '1017', 'groupId': 'BG001'}, {'value': '1945', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}, {'title': 'Immunosuppressed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '822', 'groupId': 'BG000'}, {'value': '1048', 'groupId': 'BG001'}, {'value': '1870', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '932', 'groupId': 'BG000'}, {'value': '1048', 'groupId': 'BG001'}, {'value': '1980', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The number of participants with comorbidities were collected where available. Other category includes history of myocardial infarction, congestive heart failure, peripheral vascular disease, stroke or ischemic attack, dementia, chronic obstructive pulmonary disease, history of pneumonia, connective tissue disease, peptic ulcer disease, hemiplegia, paralysis of arm(s) or leg(s), current or history of cancer (excluding lymphoma). Immunosuppression is defined as presence of either leukaemia or lymphoma or significant CD4 count depletion (either CD4 count \\<200/mm3 and/or CD4% \\<10%)\\]', 'unitOfMeasure': 'Participants', 'populationDescription': 'Due to the retrospective data collection nature of this study, data on comorbidities were not available for all participants.'}, {'title': 'Sexual history', 'classes': [{'title': 'Multiple sexual partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '523', 'groupId': 'BG000'}, {'value': '743', 'groupId': 'BG001'}, {'value': '1266', 'groupId': 'BG002'}]}]}, {'title': 'Any recent or concurrent sexually transmitted infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '1054', 'groupId': 'BG001'}, {'value': '2000', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '335', 'groupId': 'BG000'}, {'value': '373', 'groupId': 'BG001'}, {'value': '708', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Recent sexual history (3 months)', 'unitOfMeasure': 'Participants'}, {'title': 'HIV status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '946', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '9.5', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Time since HIV diagnosis at mpox diagnosis', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the PLWHIV cohort, therefore no data was collected for the HIV-negative PrEP users cohort.'}, {'title': 'Antiretroviral Therapy', 'classes': [{'title': 'Currently receiving ART', 'denoms': [{'units': 'Participants', 'counts': [{'value': '945', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '945', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '925', 'groupId': 'BG000'}, {'value': '925', 'groupId': 'BG002'}]}]}, {'title': 'Not currently receiving ART', 'denoms': [{'units': 'Participants', 'counts': [{'value': '945', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '945', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The number of participants in the PLWHIV cohort receiving antiretroviral therapy/treatment (ART).', 'unitOfMeasure': 'Participants', 'populationDescription': 'This measure is only applicable to the PLWHIV cohort, therefore no data was collected for the HIV-negative PrEP users cohort. ART variables were not available for one individual in the PLWHIV cohort so this participant is excluded from the analysis.'}, {'title': 'CD4 count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '824', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '677', 'spread': '357', 'groupId': 'BG000'}, {'value': '677', 'spread': '357', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Last CD4 count before mpox diagnosis', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the PLWHIV cohort, therefore no data was collected for the HIV-negative PrEP users cohort. CD4 data was not available for all participants in the PLHIV cohort and was collected where available.'}, {'title': 'HIV RNA levels', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '846', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '846', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7673', 'spread': '59693', 'groupId': 'BG000'}, {'value': '7673', 'spread': '59693', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Most recent HIV RNA levels before mpox diagnosis', 'unitOfMeasure': 'copies/ml', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure is only applicable to the PLWHIV cohort, therefore no data was collected for the HIV-negative PrEP users cohort. HIV RNA data was not available for all participants in the PLHIV cohort and was collected where available.'}, {'title': 'HIV RNA level <50 copies/mL', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '846', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '846', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '755', 'groupId': 'BG000'}, {'value': '755', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The number of participants with HIV RNA \\<50 copies/mL', 'unitOfMeasure': 'Participants', 'populationDescription': 'This measure is only applicable to the PLWHIV cohort, therefore no data was collected for the HIV-negative PrEP users cohort. HIV RNA data was not available for all participants in the PLHIV cohort and was collected where available.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-01', 'size': 811103, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-25T07:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2023-06-23', 'resultsFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2023-07-19', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-25', 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe Mpox Lesions', 'timeFrame': 'From date of disease onset (first symptom) until date of peak number of lesions and sites recorded (up to 3 months)', 'description': '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".'}, {'measure': 'Clinical Complications Associated With Mpox', 'timeFrame': '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:\n\n* Severe rectal and/or perianal pain (i.e. due to perianal/anal abscess, proctitis)\n* Tonsillitis and/or dysphagia\n* Secondary bacterial infection on affected skin\n* Urological complications (genital oedema, urinary retention)\n* Ocular involvement (conjunctivitis, corneal involvement, periorbital cellulitis)\n* Central nervous system involvement (encephalitis, meningitis, focal neurology signs)\n* Pneumonia/pulmonary abscess or necrotizing involvement\n* Myocarditis\n* Diarrhoea\n\nA 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.'}, {'measure': 'Number of Hospitalisation Events', 'timeFrame': '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': 'Number of hospitalisations for clinical reasons only (i.e. not for precautionary measures or quarantine).'}, {'measure': 'Death', 'timeFrame': 'From date of disease onset (first symptom) until date of death related to Mpox (up to 3 months)', 'description': 'Number of any Mpox related mortality observed during the 3 month observation period'}, {'measure': 'Differences in Mpox Lesion Severity (the Clinical Manifestation) in PLWHIV and PrEP Users', 'timeFrame': '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': '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:\n\n* Not presenting with skin lesions (0 skin lesions)\n* Mild (1-24 lesions)\n* Moderate (25-99 skin lesions)\n* Severe (100-250 skin lesions)\n* Very severe (\\>250 skin lesions) Individuals with severe or very severe lesions (ie, ≥100 skin lesions) will be classified as having "severe lesions".'}, {'measure': 'Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Site of Lesions', 'timeFrame': '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': '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).'}, {'measure': 'Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Severity Indicators', 'timeFrame': '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': 'Presence of severity indicators, below, was assessed in PLWHIV and PrEP Users with Mpox\n\n* Significant lower respiratory symptoms\n* Confusion/encephalitis,\n* Other complications (e.g. secondary bacterial infection, sepsis)\n* Widely disseminated lesions and very many in number (≥100)\n* Suspected infection of the cornea\n* Severe, refractory pain from lesions requiring hospitalisation\n* Lesions associated with complications due to pain or swelling'}, {'measure': 'Differences in the NEWS2 Score ≥5 (Severity Indicator) in PLWHIV and PrEP Users With Mpox', 'timeFrame': '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': 'National Early Warning Score \\[NEWS\\] 2 score of ≥5 was reported for PLWHIV and PrEP Users with Mpox.\n\nNEWS2 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.\n\nA 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.'}, {'measure': 'Differences in the Drug Treatments of Mpox in PLWHIV and PrEP Users', 'timeFrame': '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': 'Differences in the drug treatments (clinical manifestation) of Mpox in PLWHIV and PrEP users'}, {'measure': 'Differences in the Drug Treatments for Complications of Mpox in PLWHIV and PrEP Users', 'timeFrame': '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': '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'}, {'measure': 'Differences in the First Symptom at Onset of Mpox in PLWHIV and PrEP Users', 'timeFrame': 'Mpox onset', 'description': 'First symptom at Mpox onset including lesion onset, prodromal symptoms (e.g., fever, myalgia, etc), rectal pain or other symptoms.'}, {'measure': 'Mpox Transmission', 'timeFrame': 'Mpox onset', 'description': 'Differences between Mpox transmission characteristics in PLWHIV and PrEP users'}, {'measure': 'Mpox Transmission Characteristics', 'timeFrame': 'Mpox onset', 'description': 'Differences in days between symptom onset and positive PCR test between PLWHIV with mpox and PrEP Users with mpox'}, {'measure': 'Risk Factors for Mpox Outcomes', 'timeFrame': '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': '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)'}, {'measure': 'Risk Factors for Mpox Outcomes for PLWHIV', 'timeFrame': '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': 'Risk factors (CD4 count) for severe mpox lesions (≥100 skin lesions) for PLWHIV'}], 'secondaryOutcomes': [{'measure': 'Prevalence of Mpox During the Study Period', 'timeFrame': '1st May 2022 to 1st December 2023', 'description': '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)'}, {'measure': 'Length of Stay in Hospital', 'timeFrame': 'From date of hospital admission for Mpox until date of hospital discharge (up to 3 months)', 'description': '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.'}, {'measure': 'Time to Lesion Resolution (if Known)', 'timeFrame': 'From date of disease onset (first symptom) until date of lesion resolution (up to 3 months)', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Monkeypox', 'HIV Coinfection']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People living with HIV who are currently sexually active and HIV negative high-risk Sexual Health Clinic attenders (PrEP users) with Mpox', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of MPX was more than 90 days prior to data collection\n* Confirmed MPX infection by documented PCR testing of lesions between 1st May 2022 to 1st December 2023\n* At least 18 years of age\n* Cases (PLWHIV + MPX) i) Documented HIV-1 infection\n* Cases (PrEP users + MPX) i) Attended a clinic to receive PrEP\n\nExclusion Criteria:\n\n* MPX diagnosed based on clinical criteria only\n* MPX diagnosis was within the last 90 days'}, 'identificationModule': {'nctId': 'NCT05965427', 'acronym': 'MASH1', 'briefTitle': 'Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'NEAT ID Foundation'}, 'officialTitle': 'Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV', 'orgStudyIdInfo': {'id': '606'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PLWHIV and Mpox coinfection', 'description': '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.', 'interventionNames': ['Other: No intervention']}, {'label': 'HIV negative PrEP users with Mpox infection', 'description': '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.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Study is retrospective data collection only', 'armGroupLabels': ['HIV negative PrEP users with Mpox infection', 'PLWHIV and Mpox coinfection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Bichat Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Euroguidelines', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias I Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Nicolo Girometti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chelsea and Westminster NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NEAT ID Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}, {'name': 'PENTA Foundation', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}