Vienna HIV Infection Via Sex Study

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05326061

Acronym

HIVEX

Enrollment

500

Registered

2022-04-13

Start date

2020-07-01

Completion date

2030-12-31

Last updated

2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Contacts

Primary ContactDavid Chromy, MD

david.chromy@meduniwien.ac.at+43 1 40400 77360

Backup ContactArmin Rieger, MD

armin.rieger@meduniwien.ac.at+43 1 40400 77360

Outcome results