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Meatal Swab Yourself With Testing for Infections Collectively

NCT05870098 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2023-12-22

No results posted yet for this study

Summary

The goal of this study is

1. to improve the accuracy of chlamydia multi-site testing in men who have sex with men (MSM) and trans-women, whilst saving diagnostic costs, by comparing two new pooling methods with the 3-samples tested separately
2. to assess the diagnostic accuracy of pooled specimens for lymphogranuloma venereum detection (LGV) - a type of chlamydia infection

Chlamydia and gonorrhoea testing for MSM and trans-women usually involves 3 samples from the throat, bum and wee-pipe. The tests can be combined into a single sample pot (pooled sample) which reduces costs, but in a previous study this reduced the accuracy for finding chlamydia.

The main question for this study is:

Can the accuracy of chlamydia testing in a pooled sample be improved by reducing the amount of urine added to minimise dilution, or by using a meatal sample instead of a urine sample?

Participants will be asked to complete two sets of their own throat and bum samples, and then combine these into two pooled samples with 1)a meatal swab and 2)a smaller amount of first catch urine. The order of these samples will be randomised. These samples will be compared against separate samples taken at the same visit, to see how accurate the pooled samples are at diagnosing chlamydia and gonorrhoea with the different sampling techniques.

Conditions

  • Chlamydia
  • Gonorrhea

Interventions

DIAGNOSTIC_TEST

All participants

1. Clinician or self-taken, pharyngeal and rectal swabs with FCU analysed individually 2. Self-taken pharyngeal, meatal, and rectal swabs analysed as a pooled specimen 3. Self-taken pharyngeal and rectal swabs with 1.5ml FCU analysed as a pooled specimen The FCU will be done after any meatal swabs. Patients will be instructed to only pass the first 5ml into the tube, and the tube will be pre-marked with a black line. Full pictoral instructions and verbal support will be given to enable them to complete the pooling process of the swabs and urine.

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Janet Wilson, MB ChB · Leeds Teaching Hospitals NHS Trust

  • Harriet Wallace, MB ChB · Leeds Teaching Hospitals NHS Trust

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-18
Primary Completion
2024-05-29
Completion
2024-08-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870098 on ClinicalTrials.gov