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NCT Number: NCT05326061

Vienna HIV Infection Via Sex 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.

Recruiting

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Key information

Conditions

HIV Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Chlamydia Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Disease Attributes Genital Diseases Gonorrhea Gram-Negative Bacterial Infections HIV Pre-Exposure Prophylaxis Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neisseriaceae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases, Viral Spirochaetales Infections Syphilis Treponemal Infections Urogenital Diseases Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Armin Rieger, MD

CONTACT

[email protected]

+4314040077360

Armin Rieger, MD

PRINCIPAL_INVESTIGATOR

David Chromy, MD

CONTACT

[email protected]

+4314040077360

David Chromy, MD

SUB_INVESTIGATOR

Katharina Grabmeier-Pfistershammer, MD

SUB_INVESTIGATOR

Michael Skoll, MD

SUB_INVESTIGATOR

Wolfgang Bauer, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of HIV

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

    Time from inclusion to HIV infection

Secondary outcomes

  1. Incidence of sexually transmitted infections

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

    Time from inclusion to any sexually transmitted infections

Study contacts

Contact information is provided by the study sponsor or research team.

Armin Rieger, MD

CONTACT

[email protected]

+43 1 40400 77360

David Chromy, MD

CONTACT

[email protected]

+43 1 40400 77360

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: HIVEX

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Apr 13, 2022
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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