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Clinical Trials/NCT05326061
NCT05326061
Recruiting
N/A

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

Medical University of Vienna1 site in 1 country500 target enrollmentJuly 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Medical University of Vienna
Enrollment
500
Locations
1
Primary Endpoint
Incidence of HIV
Status
Recruiting
Last Updated
4 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
December 2030
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Armin Rieger, MD

Ass.-Prof. Dr.med.univ.

Medical University of Vienna

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

  • Withdrawal of the written informed consent.

Outcomes

Primary Outcomes

Incidence of HIV

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

Time from inclusion to HIV infection

Secondary Outcomes

  • Incidence of sexually transmitted infections(Up to 10 years (=Study Period))

Study Sites (1)

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