An observational study in Mpox (Monkeypox), sponsored by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia. Completed at 1 site in Democratic Republic of the Congo. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Observational
The MOVIE-TRACE project includes two complementary observational studies designed to improve the understanding of Mpox virus infection and its transmission within affected communities. The MOVIE study aims to describe the dynamics of viral clearance in patients with confirmed Mpox. It measures how the viral load changes over time in different biological samples to inform decisions about patient management and isolation guidelines. The TRACE study focuses on understanding how mpox spreads from confirmed cases to their contacts. It will estimate the Secondary Attack Rate (SAR) and identify factors associated with transmission risk. The results will help guide public health strategies for contact tracing, vaccination, and outbreak control.
Starting in late 2023, an increasing number of confirmed cases of Mpox caused by clade I Mpox virus (MPXV) were reported across several provinces of the Democratic Republic of the Congo (DRC). In August 2024, the World Health Organization (WHO) declared the ongoing outbreak a Public Health Emergency of International Concern due to its expanding geographic spread and significant public health impact.
Mpox is transmitted through direct contact with skin or mucosal lesions of infected individuals, contaminated materials. MPXV can be detected in multiple biological samples, including skin lesion swabs, blood, throat swabs, and occasionally urine. However, there is still limited information on how long and in which compartments the virus can persist, as well as on how efficiently it spreads between individuals during community outbreaks caused by clade I virus.
The MOVIE-TRACE project includes two complementary observational studies designed to address these critical gaps in knowledge and to strengthen the understanding of clade I MPXV infection in the DRC.
The MOVIE study aims to describe how MPXV is cleared from the body over time among patients with PCR-confirmed Mpox infection. Despite the importance of isolation and infection control in outbreak management, there is limited evidence on how long individuals remain infectious. MOVIE addresses this critical gap by conducting longitudinal follow-up of Mpox-positive patients for up to two months, with several scheduled visits during which multiple biological specimens are collected. These samples will be analyzed to assess viral persistence in different body compartments and to characterize the kinetics of viral clearance. The findings will help refine isolation duration, improve clinical management, and guide infection prevention policies.
The TRACE study seeks to understand how Mpox spreads from confirmed cases to their contacts. By systematically collecting exposure data and testing contacts for infection, TRACE will estimate the Secondary Attack Rate (SAR) and identify factors that increase the likelihood of transmission. This information will support public health measures such as contact tracing, quarantine strategies, and targeted vaccination in endemic regions.
Together, MOVIE and TRACE will generate essential evidence on both viral clearance and transmission of clade I MPXV, providing a comprehensive understanding of the infection and informing data-driven outbreak response strategies in the Democratic Republic of the Congo.
72 studies on the registry are indexed under Mpox, Monkeypox; 30 are open to participants now.
This study's enrollment of 550 is above the median of 224 across 34 observational studies indexed under Mpox, Monkeypox.
Browse Mpox, Monkeypox studies →Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia is the lead sponsor of 45 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All individuals with confirmed Mpox infection, regardless of age or sex.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
MOVIE Study:
TRACE Study:
Exclusion Criteria:
MOVIE Study:
TRACE Study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mpox confirmed case
Contact of a MOVIE case
Time to undetectable MPXV DNA in skin lesion swabs measured by quantitative PCR
Time from enrollment to the first skin lesion swab with undetectable MPXV DNA, defined as cycle threshold (Ct) \>35 by quantitative polymerase chain reaction (qPCR).
Time frame: From day 1 to day 56
Time to undetectable MPXV DNA in oropharyngeal swabs measured by quantitative PCR
Time from enrollment to the first oropharyngeal swab with undetectable MPXV DNA, defined as Ct \>35 by qPCR.
Time frame: From day 1 to day 56
Time to undetectable MPXV DNA in blood measured by quantitative PCR
Time from enrollment to the first blood sample with undetectable MPXV DNA, defined as Ct \>35 by qPCR.
Time frame: From day 1 to day 56
Secondary attack rate of mpox among contacts of index cases
Secondary attack rate (SAR), defined as the proportion of contacts of laboratory-confirmed mpox cases who develop laboratory-confirmed mpox during follow-up, assessed through clinical evaluation and MPXV qPCR testing.
Time frame: From day 1 to day 14
Epidemiological, clinical, and exposure-related factors associated with mpox transmission
Transmission-related factors will be assessed using standardized epidemiological questionnaires and clinical case report forms administered to index cases and contacts at baseline and follow-up. Variables assessed will include type and frequency of contact, exposure to skin lesions or bodily fluids, sleeping arrangements, sexual contact, household characteristics, symptoms, lesion burden, and MPXV DNA results by qPCR. Associations with transmission will be evaluated by comparing characteristics of transmitting versus non-transmitting index cases and infected versus non-infected contacts.
Time frame: From day 1 to day 14
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Individual participant data (IPD) will be shared under reasonable request
Ran from Oct 2025 to primary completion in Feb 2026, 3 months.
Of 23 observational studies under Mpox, Monkeypox, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia