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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027047

Enrollment

360

Registered

2021-12-03

Start date

2021-09-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Sexually transmittable diseases A64

Interventions

Group 1: first self-collected, then physician-guided Group 2: first physician-guided, then self-collected

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
- 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) - evaluation of the usability and advantages of eSwabs through the subject (self-collection) - recognition of possible problems in the performance of self-collection, and validation of a manual designed for this purpose - evaluation of practicability between urethral swabs and urine testing.	—

Measure

Time frame

- 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) - evaluation of the usability and advantages of eSwabs through the subject (self-collection) - recognition of possible problems in the performance of self-collection, and validation of a manual designed for this purpose - evaluation of practicability between urethral swabs and urine testing.

—

Countries

Germany

Contacts

Public ContactChristoph Spinner

IZAR

izar@mri.tum.de089/41402451

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026