HIVEX: Vienna HIV Infection Via Sex Study

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT05326061

Collaborator

(none)

500

Enrollment

Location

125

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections HIV Pre-Exposure Prophylaxis Sexually Transmitted Diseases Gonorrhea Chlamydia Syphilis

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2030

Anticipated Study Completion Date :

Dec 1, 2030

Outcome Measures

Primary Outcome Measures

Incidence of HIV [Up to 10 years (=Study Period)]
Time from inclusion to HIV infection

Secondary Outcome Measures

Incidence of sexually transmitted infections [Up to 10 years (=Study Period)]
Time from inclusion to any sexually transmitted infections

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.