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Study with close contacts of monkeypox patients

Where you in close contact with someone who was diagnosed with a monkeypox infection?

28-06-22

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Monkeypox does not usually cause serious illness in healthy adults, but it is contagious. It is transmitted by contact with body fluids, contaminated surfaces or linen. A monkeypox infection is manifested by characteristic skin lesions such as red spots, pimples or blisters. These can be spread all over the body, even on the face and the palms of the hands. The lesions develop scabs, after which they heal.

To study the risk of transmission of the monkeypox virus, ITM is conducting a new study, in which we will follow people who came into contact with someone infected with the virus. We want to find out if and when the infection manifests itself after contact. The study has been named the “Monkey_Pox ASymptoatic Shedding – Evaluation by Self Sampling (MPX-ASSESS) Study”.

Who can participate?

All close contacts of known cases of monkeypox. These include people living in the same household or sexual partners.

How is the study set up and what tests are carried out?

Contacts will be followed for up to 21 days, depending on the time of the last exposure.

If the last exposure occurred less than 7 days before participation in the study, four study visits to ITM are planned: on the day of the study start (day 1) and after 7, 14 and 21 days.

If exposure is more than 14 days prior to study participation, only one study visit is foreseen on day 1.

During these visits, a doctor will ask a number of questions and perform an examination. In addition, the doctor will take the following samples to check for signs of a monkeypox infection:

  • A throat swab
  • One tube of venous blood (maximum 10 ml)

Between study visits, we will ask you to log certain information on a daily basis:

  • Write down your temperature and any symptoms in a diary;
  • Take three samples to look for signs of a starting infection. These are a saliva sample, an anal swab and a genital swab.

You will receive clear instructions and the necessary material to take the samples with. You hand them in during your follow-up visit.

As long as you are symptom free, the investigators will not immediately analyse the samples. If you do show symptoms, we will ask you to come to ITM for an evaluation and diagnostic tests. If you also have skin lesions, we will take photographs to properly document the evolution of the disease.

 

Why participate?

All study procedures and tests are free of charge. Contacts of monkey pox patients are followed up more intensively than usual in this study. This allows us to detect a possible infection earlier. However, the main goal of the study is to better understand monkeypox and the risk of infection. By participating, you will help increase our knowledge about monkeypox, which will help contain outbreaks. In addition, we provide a fee of EUR 20 for each study visit.

 

Is there any risk in participating in the study?

There is no significant risk for you to participate in this study.

 

Confidentiality

We protect your privacy and treat your personal data in accordance with the European General Data Protection Regulation (GDPR). Your personal or medical data are identified with a code and not with your name. It is therefore impossible for researchers to discover your identity. When photos are shared for scientific publication, this is always done in an anonymised way, which means that you are not identifiable in the photo. 

The persons authorised to access your data are bound by absolute professional confidentiality. You always have the right to access your personal and medical data.

 

What happens to my samples after the study?

We want to keep the samples taken during the study for additional testing later. If you agree, we will store your samples up to a maximum of 20 years in the ITM biobank (FAGG registration number: BB190041, biobank@itg.be) in accordance with Belgian biobanking legislation. You have the right to refuse this long-term storage, which means we will discard all your samples after the final study report has been published. Your samples will not be sold or used for commercial purposes. No tests will ever be carried out on your genetic material without your additional consent. Additional research using your samples or data must always be approved by ITM's Institutional Review Board.

 

Voluntary participation

If you do not wish to participate, this will not affect the care and attention you receive from us, either now or in the future. Your decision regarding the later use of your samples and data is entirely voluntary and you can withdraw your consent at any time.

 

Further questions?

If you have any questions now or in the future about monkeypox research activities, the subsequent use of your data, samples and pictures, the withdrawal of your consent or the inspection and/or correction of your data, please contact:

  • The study team: +32 (0)3 345 56 75

Do you have any questions about the processing of your personal data? Please contact informatieveiligheid@itg.be or +32 (0)3 247 07 43.

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