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RecruitingNCT05326061HIVEXUpdated Apr 13, 2022

Vienna HIV Infection Via Sex Study

An observational study in HIV Infections, HIV Pre-Exposure Prophylaxis and Sexually Transmitted Diseases, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-04-13.

Sponsored by Medical University of Vienna · Observational

From the registry’s dates

  • Started Jul 2020; still recruiting 6 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 100 Years
Sex
All
01

Study summary

The main objective of this prospective observational cohort study is to investigate the epidemiology, the risk factors and ultimately the incidence of novel HIV infections among individuals at high risk for acquiring HIV via sex practices.

Read the detailed description

We will include individuals at high-risk for HIV acquisition, i.e. HIV-negative MSM and transgender individuals who (i) do not use condoms consistently with casual partners and/or with HIV-positive partners who are not on treatment and/or (ii) recently acquired an STI and/or (iii) recently used PEP and/or (iv) frequently engage in 'chemsex' within the past 12 months Important clinical information on possible vectors for transmission (including but not limited to high-risk sex practices and sexualized drug use), use of HIV pre-exposure prophylaxis, incidence of sexually transmitted infections will be assessed and laboratory parameters will be obtained from blood, urine and mucosal secretion.

02

Conditions studied

  • HIV Infections
  • HIV Pre-Exposure Prophylaxis
  • Sexually Transmitted Diseases
  • Gonorrhea
  • Chlamydia
  • Syphilis
03

In context

HIV Infections

4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 781 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients presenting at the HIV- and/or STI ward of the Department of Dermatology at General Hospital of Vienna which are characterized as individuals at high risk for acquiring HIV will be considered as potential participants for the HIVEX registry.

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.

Inclusion criteria

  1. High risk for acquiring defined as followed: HIV-negative MSM and transgender individuals who (i) do not use condoms consistently with casual partners and/or with HIV-positive partners who are not on treatment and/or (ii) recently acquired an STI and/or (iii) recently used PEP and/or (iv) frequently engage in 'chemsex'.
  2. Age >18 years and \<100 years.
  3. Written for this registry study.

Exclusion criteria

Exclusion Criteria:

  1. Withdrawal of the written .
Terms in these criteria, in plain language(2)

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Incidence of HIV

    Time from inclusion to HIV infection

    Time frame: Up to 10 years (=Study Period)

Secondary outcomes

  1. Incidence of sexually transmitted infections

    Time from inclusion to any sexually transmitted infections

    Time frame: Up to 10 years (=Study Period)

07

Study locations

1 of 1 sites recruiting
  • Medical University of Vienna
    Vienna, 1090, Austria
    Recruiting
    • David Chromy, MD · Contactdavid.chromy@meduniwien.ac.at · +4314040077360
    • Armin Rieger, MD · Contactarmin.rieger@meduniwien.ac.at · +4314040077360
    • Armin Rieger, MD · Principal investigator
    • David Chromy, MD · Sub investigator
    • Wolfgang Bauer, MD · Sub investigator
    • Katharina Grabmeier-Pfistershammer, MD · Sub investigator
    • Michael Skoll, MD · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05326061
Responsible party
Armin Rieger, MD (Ass.-Prof. Dr.med.univ., Medical University of Vienna) — Principal investigator
First posted
Apr 13, 2022
Start date
Jul 1, 2020
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Apr 13, 2022

Study contacts

David Chromy, MD
Contact
david.chromy@meduniwien.ac.at
+43 1 40400 77360
Armin Rieger, MD
Contact
armin.rieger@meduniwien.ac.at
+43 1 40400 77360

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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