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

NCT ID: NCT05965427

Last Updated: 2025-08-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-05-07

Brief Summary

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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.

Detailed Description

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Conditions

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Monkeypox HIV Coinfection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PLWHIV and Mpox coinfection

People living with HIV(PLWHIV) who are at least 18 years of age, with confirmed Mpox infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.

No intervention

Intervention Type OTHER

Study is retrospective data collection only

HIV negative PrEP users with Mpox infection

HIV negative PrEP (Pre-exposure prophylaxis) users who are at least 18 years of age, with confirmed Mpox infection by documented, positive result on PCR testing of lesions from 1st May 2022 to 1st December 2023.

No intervention

Intervention Type OTHER

Study is retrospective data collection only

Interventions

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No intervention

Study is retrospective data collection only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of MPX was more than 90 days prior to data collection
* Confirmed MPX infection by documented PCR testing of lesions between 1st May 2022 to 1st December 2023
* At least 18 years of age
* Cases (PLWHIV + MPX) i) Documented HIV-1 infection
* Cases (PrEP users + MPX) i) Attended a clinic to receive PrEP

Exclusion Criteria

* MPX diagnosed based on clinical criteria only
* MPX diagnosis was within the last 90 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Commission

OTHER

Sponsor Role collaborator

PENTA Foundation

NETWORK

Sponsor Role collaborator

NEAT ID Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolo Girometti, MD

Role: PRINCIPAL_INVESTIGATOR

Chelsea and Westminster NHS Trust

Locations

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Hôpital Bichat Claude Bernard

Paris, , France

Site Status

Hôpital Pitié-Salpêtrière

Paris, , France

Site Status

Euroguidelines

Warsaw, , Poland

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitari Germans Trias I Pujol

Barcelona, , Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital San Carlos

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Chelsea and Westminster Hospital

London, , United Kingdom

Site Status

Countries

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France Poland Spain United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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606

Identifier Type: -

Identifier Source: org_study_id

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