Vienna HIV Infection Via Sex Study

Recruiting

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

• Registration Number: NCT05326061
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-06
• Last Update Submitted: 2022-04-06
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-13
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

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Exclusion Criteria

1. Withdrawal of the written informed consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria