N/A
N=2,000
Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
Monkeypox · HIV Coinfection
Bottom Line
View on ClinicalTrials.gov: NCT05965427 ↗Enrolled (actual)
2,000
Serious AEs
4.8%
Results posted
Aug 2025
Primary outcome: Primary: Severe Mpox Lesions — 6; 2 participants — p=0.097
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NEAT ID Foundation
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severe Mpox Lesions |
6; 2 | 0.097 |
| PRIMARY Clinical Complications Associated With Mpox |
192; 242; 38; 50; 21; 22 | 0.005 sig |
| PRIMARY Number of Hospitalisation Events |
57; 38 | 0.011 sig |
| PRIMARY Death |
0; 0 | — |
| PRIMARY Differences in Mpox Lesion Severity (the Clinical Manifestation) in PLWHIV and PrEP Users |
36; 61; 676; 805; 48; 38 | 0.002 sig |
| PRIMARY Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Site of Lesions |
425; 565; 454; 409; 149; 133 | — |
| PRIMARY Differences in the Clinical Manifestation of Mpox in PLWHIV and PrEP Users by Severity Indicators |
1; 1; 0; 0; 98; 122 | — |
| PRIMARY Differences in the NEWS2 Score ≥5 (Severity Indicator) in PLWHIV and PrEP Users With Mpox |
1; 0 | — |
| PRIMARY Differences in the Drug Treatments of Mpox in PLWHIV and PrEP Users |
10; 4; 3; 3; 13; 7 | 0.114 |
| PRIMARY Differences in the Drug Treatments for Complications of Mpox in PLWHIV and PrEP Users |
292; 409; 170; 209; 246; 333 | <0.001 sig |
| PRIMARY Differences in the First Symptom at Onset of Mpox in PLWHIV and PrEP Users |
322; 500; 425; 327; 66; 47 | <0.001 sig |
| PRIMARY Mpox Transmission |
95; 262; 777; 701; 74; 91 | — |
| PRIMARY Mpox Transmission Characteristics |
6; 7 | — |
| PRIMARY Risk Factors for Mpox Outcomes |
6; 760; 2; 904; 0; 269 | — |
| PRIMARY Risk Factors for Mpox Outcomes for PLWHIV |
680; 683 | — |
| SECONDARY Prevalence of Mpox During the Study Period |
0.34; 0.85; 0.99; 2.90; 1.54; 3.07 | — |
| SECONDARY Length of Stay in Hospital |
6; 6 | — |
| SECONDARY Time to Lesion Resolution (if Known) |
18; 17 | — |
Summary
This data collection study aims to describe and compare the outcomes of Mpox on people living with HIV (PLHIV) and HIV-negative individuals who are on pre-exposure prophylaxis (PrEP). The study also aims to identify risk factors for specific Mpox outcomes.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05965427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.