Evaluation of self-collected versus physician guided sampling and potential impact on diagnostic results of Sexually Transmitted Infections (STI) in subjects with increased risk

Not Applicable

• Conditions: Sexually transmittable diseases; A64; Unspecified sexually transmitted disease

• Registration Number: DRKS00027047
• Lead Sponsor: Klinikum rechts der Isar der TU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-03
• Study Completion: 2022-08-05
• Results First Posted: 2023-08-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 237

Inclusion Criteria

Self-identification as MSM and >2 condomless anal intercourses within the last 24 weeks with 2 different partners before study
inclusion
- Written informed consent
- Age >18 years

Exclusion Criteria

- Any symptoms of a present STI or treatment of an active STI within 14 days prior to screening

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences of sensitivity concerning the diagnosis of STI (CT/NG) through physician-guided vs. self-sampling in asymptomatic STI subjects at risk.

Secondary Outcome Measures

Name	Time	Method
- prevalence of STIs in different locations (rectal, urethral, pharyngeal) according to risk behavior in MSM (number of partners, condomless sex, use of PrEP) and other STIs (Hepatitis B, C as well as HIV and Syphilis) <br>- evaluation of the usability and advantages of eSwabs through the subject (self-collection)<br>- recognition of possible problems in the performance of self-collection, and validation of a manual designed for this purpose<br>- evaluation of practicability between urethral swabs and urine testing.