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Recruiting NCT05326061

Vienna HIV Infection Via Sex Study

Observational HIV Infections HIV Pre-Exposure Prophylaxis Sexually Transmitted Diseases Gonorrhea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: HIV Infections, HIV Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Gonorrhea. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Characterization of Patients at High Risk for the Acquisition of Sexually Transmitted Infection With the Human Immunodeficiency Virus (HIV) - a Clinical Study

Overview

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.

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.

Primary outcome measures

  • Incidence of HIV [Time frame: Up to 10 years (=Study Period)]
Secondary outcome measures (1)
  • Incidence of sexually transmitted infections [Time frame: Up to 10 years (=Study Period)]

Eligibility criteria

Inclusion criteria

  • High risk for acquiring HIV 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'.
  • Age >18 years and <100 years.
  • Written informed consent for this registry study.

Exclusion criteria

1\. Withdrawal of the written informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Medical University of Vienna — Vienna

Identifiers

NCT: NCT05326061 · 1051_2020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗