Vienna HIV Infection Via Sex Study (HIVEX)

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections; Sexually Transmitted Diseases; Chlamydia; Gonorrhea; Syphilis; HIV Pre-Exposure Prophylaxis

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: David Chromy, MD; Phone Number: +43 1 40400 77360; Email: david.chromy@meduniwien.ac.at
• Study Contact Backup: Name: Armin Rieger, MD; Phone Number: +43 1 40400 77360; Email: armin.rieger@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: David Chromy, MD; Phone Number: +4314040077360; Email: david.chromy@meduniwien.ac.at
    • Contact: Armin Rieger, MD; Phone Number: +4314040077360; Email: armin.rieger@meduniwien.ac.at
    • Principal Investigator: Armin Rieger, MD
    • Sub-Investigator: David Chromy, MD
    • Sub-Investigator: Wolfgang Bauer, MD
    • Sub-Investigator: Katharina Grabmeier-Pfistershammer, MD
    • Sub-Investigator: Michael Skoll, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

1. 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'.
2. Age >18 years and <100 years.
3. Written informed consent for this registry study.

Exclusion Criteria:

1. Withdrawal of the written informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of HIV	Time from inclusion to HIV infection	Up to 10 years (=Study Period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of sexually transmitted infections	Time from inclusion to any sexually transmitted infections	Up to 10 years (=Study Period)

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 1, 2030
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Slow Virus Diseases; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Spirochaetales Infections; Treponemal Infections; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Gonorrhea; Sexually Transmitted Diseases; Syphilis
• Other Study ID Numbers: 1051_2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No