Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00022403

Trial Description

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Title

SARS-CoV-2 serology in HIV PrEP users during the COVID-19 pandemic: THE PREP-CO STUDY

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Trial Acronym

PrEP-Co

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

To investigate to prevalence and seroconversion rate of SARS-CoV-2 antibodies in a German cohort of MSM using HIV PrEP, Germany, over a time period of one year following the first outbreak of the covid pandemic.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00022403
  •   2020/07/15
  •   [---]*
  •   yes
  •   Approved
  •   292/20 S, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   HIV-PrEP
  •   STD
  •   Z29.21 -  [generalization Z29.2: Other prophylactic chemotherapy]
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Interventions/Observational Groups

  •   Performance of SARS-CoV-2 serology
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Seroconversion rate pointprevalence of SARS-CoV-2 antibody during the time of this study.

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Secondary Outcome

- Pointprevalence of SARS-CoV-2 antibodies at baseline.
- Pointprevalence of SARS-CoV-2 antibodies at follow-up visits.
- correlation of the seroprevalence and/or seroconversion of SARS-CoV-2 positivity with sexual behaviour and other sexual transmitted diseases (STDs), such as syphilis, N. gonococcae, M. genitalium, C.trachomatis or HIV.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/05/18
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- MSM reporting PrEP-use within last 90 months prior to screening visit
- Written informed consent.
- Age ≥18 years.

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Exclusion Criteria

Persons with any kind of dependency on the investigator.

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Addresses

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    • Klinikum Rechts der Isar
    • Ismaninger Str 22
    • 81675  München
    • Germany
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    •   [---]*
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    • Klinik und Poliklinik für Innere Medizin IIKlinikum Rechts der Isar der TU München
    • Mr.  PD Dr.  Christoph  Spinner 
    • Ismaninger Str 22
    • 81675  München
    • Germany
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    • IZAR
    • Mr.  PD Dr.  Christoph  Spinner 
    • Ismaninger Str 21
    • 81675  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Innere Medizin IIKlinikum Rechts der Isar der TU München
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.