Trial · NCT05965427
Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
NCT05965427, Completed, NEAT ID Foundation; results first posted 2025-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV. Trials, record NCT05965427. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05965427
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
- NCT number
- NCT05965427
- Status
- Completed
- Enrollment
- 2,000 participants, actual
- Lead sponsor
- NEAT ID Foundation
- Conditions
- Monkeypox, HIV Coinfection
- Interventions
- No intervention
- First posted
- 2023-07-28
- Last updated
- 2025-08-13
- Results first posted
- 2025-08-13
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Severe Mpox Lesions | From date of disease onset (first symptom) until date of peak number of lesions and sites recorded (up to 3 months) | The number of participants with severe Mpox lesions. Severity of lesions will be assessed by the peak number of lesions and peak number of sites. Participants with ≥100 lesions at peak severity will be classified as having "severe lesions". |
| Primary | Clinical Complications Associated With Mpox | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | Complications which will be collected are as follows: * Severe rectal and/or perianal pain (i.e. due to perianal/anal abscess, proctitis) * Tonsillitis and/or dysphagia * Secondary bacterial infection on affected skin * Urological complications (genital oedema, urinary retention) * Ocular involvement (conjunctivitis, corneal involvement, periorbital cellulitis) * Central nervous system involvement (encephalitis, meningitis, focal neurology signs) * Pneumonia/pulmonary abscess or necrotizing involvement * Myocarditis * Diarrhoea A composite outcome representing the presence of any specified clinical complication will be analysed. This composite outcome will be derived by identifying participants who have experienced one or more of the listed clinical complications during the observation period. |
| Primary | Number of Hospitalisation Events | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | Number of hospitalisations for clinical reasons only (i.e. not for precautionary measures or quarantine). |
| Primary | Death | From date of disease onset (first symptom) until date of death related to Mpox (up to 3 months) | Number of any Mpox related mortality observed during the 3 month observation period |
| Primary | Differences in Mpox Lesion Severity (the Clinical Manifestation) in PLWHIV and PrEP Users | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | The severity of lesions will be determined based on the peak/maximum severity score over the observation period. Lesion severity will be classified ordinally as follows: * Not presenting with skin lesions (0 skin lesions) * Mild (1-24 lesions) * Moderate (25-99 skin lesions) * Severe (100-250 skin lesions) * Very severe (\>250 skin lesions) Individuals with severe or very severe lesions (ie, ≥100 skin lesions) will be classified as having "severe lesions". |
| Primary | Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Site of Lesions | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | Differences in the clinical manifestation of Mpox in PLWHIV and PrEP users by site of lesions. 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). |
| Primary | Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Severity Indicators | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | Presence of severity indicators, below, was assessed in PLWHIV and PrEP Users with Mpox * Significant lower respiratory symptoms * Confusion/encephalitis, * Other complications (e.g. secondary bacterial infection, sepsis) * Widely disseminated lesions and very many in number (≥100) * Suspected infection of the cornea * Severe, refractory pain from lesions requiring hospitalisation * Lesions associated with complications due to pain or swelling |
| Primary | Differences in the NEWS2 Score ≥5 (Severity Indicator) in PLWHIV and PrEP Users With Mpox | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | National Early Warning Score \[NEWS\] 2 score of ≥5 was reported for PLWHIV and PrEP Users with Mpox. NEWS2 is a summary score of six physiological parameters (respiratory rate, oxygen saturation, systolic blood pressure, heart rate, level of consciousness, temperature, and supplemental oxygen dependency) routinely recorded for inpatients. Each parameter is assigned a score between 0-3 based on how far it deviates from the normal range. These parameters are used to generate an aggregate severity score classified as low: aggregate score 0-4, low -medium/medium: score of 3 in any individual parameter/aggregate score 5-6,high: aggregate score 7 or more. Minimum scale score is 0, Maximum scale score is 20. A higher score indicates a greater clinical risk and worse outcome. A score ≥5 is a key threshold for urgent clinical review and signifies severe disease. |
| Primary | Differences in the Drug Treatments of Mpox in PLWHIV and PrEP Users | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | Differences in the drug treatments (clinical manifestation) of Mpox in PLWHIV and PrEP users |
| Primary | Differences in the Drug Treatments for Complications of Mpox in PLWHIV and PrEP Users | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | Differences in the drug treatments for complications of Mpox (secondary infections, bronchopneumonia, sepsis, encephalitis, and infection of the cornea with ensuing loss of vision) in PLWHIV and PrEP users |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Severe Mpox Lesions | From date of disease onset (first symptom) until date of peak number of lesions and sites recorded (up to 3 months) | 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. | participants | NUMBER |
| PRIMARY | Clinical Complications Associated With Mpox | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | Clinical complication data was not available for available for all participants due to the retrospective data collection nature of this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Hospitalisation Events | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | Events | NUMBER | |
| PRIMARY | Death | From date of disease onset (first symptom) until date of death related to Mpox (up to 3 months) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Differences in Mpox Lesion Severity (the Clinical Manifestation) in PLWHIV and PrEP Users | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | participants | NUMBER | |
| PRIMARY | Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Site of Lesions | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | Site of lesion data was not available for all participants due to the retrospective data collection in this study. | participants | NUMBER |
| PRIMARY | Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Severity Indicators | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | Severity indicators were not available for all participants due to the retrospective nature of this data collection study. | participants | NUMBER |
| PRIMARY | Differences in the NEWS2 Score ≥5 (Severity Indicator) in PLWHIV and PrEP Users With Mpox | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | NEWS2 score was not available for all participants due to the retrospective nature of this data collection study. | participants | NUMBER |
| PRIMARY | Differences in the Drug Treatments of Mpox in PLWHIV and PrEP Users | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Differences in the Drug Treatments for Complications of Mpox in PLWHIV and PrEP Users | From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death (up to 3 months) | 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group147
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Severe Mpox Lesions | PLWHIV and Mpox Coinfection | 6 | participants | ||
| Severe Mpox Lesions | HIV Negative PrEP Users With Mpox Infection | 2 | participants | ||
| Clinical Complications Associated With Mpox | PLWHIV and Mpox Coinfection | Severe rectal and/or perianal pain | 192 | Participants | |
| Clinical Complications Associated With Mpox | HIV Negative PrEP Users With Mpox Infection | Severe rectal and/or perianal pain | 242 | Participants | |
| Clinical Complications Associated With Mpox | PLWHIV and Mpox Coinfection | Tonsilitis | 38 | Participants | |
| Clinical Complications Associated With Mpox | HIV Negative PrEP Users With Mpox Infection | Tonsilitis | 50 | Participants | |
| Clinical Complications Associated With Mpox | PLWHIV and Mpox Coinfection | Dysphagia | 21 | Participants | |
| Clinical Complications Associated With Mpox | HIV Negative PrEP Users With Mpox Infection | Dysphagia | 22 | Participants | |
| Clinical Complications Associated With Mpox | PLWHIV and Mpox Coinfection | Secondary bacterial infection on affected skin | 108 | Participants | |
| Clinical Complications Associated With Mpox | HIV Negative PrEP Users With Mpox Infection | Secondary bacterial infection on affected skin | 124 | Participants |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PLHIV and Mpox Coinfection | 946 | |
| Overall Study | STARTED | HIV Negative PrEP Users With Mpox Infection | 1,054 | |
| Overall Study | COMPLETED | PLHIV and Mpox Coinfection | 946 | |
| Overall Study | COMPLETED | HIV Negative PrEP Users With Mpox Infection | 1,054 | |
| Overall Study | NOT COMPLETED | PLHIV and Mpox Coinfection | 0 | |
| Overall Study | NOT COMPLETED | HIV Negative PrEP Users With Mpox Infection | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hospitalisation | General disorders | PLWHIV and Mpox Coinfection | 57 | 946 | |
| serious | Hospitalisation | General disorders | HIV Negative PrEP Users With Mpox Infection | 38 | 1,054 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PLWHIV and Mpox Coinfection | 0 | 946 |
| Total, all-cause mortality | HIV Negative PrEP Users With Mpox Infection | 0 | 1,054 |
| Total, other adverse events | PLWHIV and Mpox Coinfection | 0 | 0 |
| Total, other adverse events | HIV Negative PrEP Users With Mpox Infection | 0 | 0 |
| Total, serious adverse events | PLWHIV and Mpox Coinfection | 57 | 946 |
| Total, serious adverse events | HIV Negative PrEP Users With Mpox Infection | 38 | 1,054 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PLWHIV and Mpox Coinfection vs HIV Negative PrEP Users With Mpox Infection: Differences in the NEWS2 Score ≥5 (Severity Indicator) in PLWHIV and PrEP Users With Mpox | Trial comparisons |
| PLWHIV and Mpox Coinfection vs HIV Negative PrEP Users With Mpox Infection: Death | Trial comparisons |
| PLWHIV and Mpox Coinfection vs HIV Negative PrEP Users With Mpox Infection: Severe Mpox Lesions | Trial comparisons |
| PLWHIV and Mpox Coinfection vs HIV Negative PrEP Users With Mpox Infection: deaths from any cause | Trial comparisons |
| PLWHIV and Mpox Coinfection vs HIV Negative PrEP Users With Mpox Infection: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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