Vienna HIV Infection Via Sex Study

HIV Infections Clinical Trial

— HIVEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326061
• Other study ID #: 1051_2020
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 2030

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: David Chromy, MD
• Phone: +43 1 40400 77360
• Email: david.chromy[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Chlamydia
• Communicable Diseases
• Gonorrhea
• HIV Infections
• Infections
• Sexually Transmitted Diseases
• Syphilis

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of HIV	Time from inclusion to HIV infection	Up to 10 years (=Study Period)
Secondary	Incidence of sexually transmitted infections	Time from inclusion to any sexually transmitted infections	Up to 10 years (=Study Period)