Meatal Swab Yourself With Testing for Infections Collectively

NCT05870098 | Unknown

• 1 other identifier: GU19-125925
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is

1. 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. 2.to assess the diagnostic accuracy of pooled specimens for lymphogranuloma venereum detection (LGV) - a type of chlamydia infection

Conditions

Chlamydia; Gonorrhea

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity for gonorrhoea, chlamydia and LGV diagnosis using NAATS

  To improve the accuracy of chlamydia diagnoses in MSM and trans-women by comparing two new pooling methods with the 3-samples tested separately, and to assess the diagnostic accuracy of pooled specimens for lymphogranuloma venereum detection (LGV) - a type of chlamydia infection

  14 months

Secondary Outcomes (2)

• Participant satisfaction with using meatal swabs compared with first catch urine for the diagnosis of gonorrhoea, chlamydia, and LGV as measured by a Likert scale

  14 months

• Participant satisfaction with taking and pooling combined site samples, compared with individually analysed samples for the diagnosis of gonorrhoea, chlamydia, and LGV as measured by a Likert scale

  14 months

Study Arms (1)

All participants

OTHER

All participants will receive: 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.

Diagnostic Test: All participants

Interventions

All participants DIAGNOSTIC_TEST

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.

All participants

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males who have sex with males, and trans-females with a penis
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over. Willing to perform self-taken swabs in addition to any clinician required swabs. Able to provide informed consent

You may not qualify if:

• \- Antibiotics taken in the past 14 days (excluding metronidazole). Previous participation in this trial

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS1 3EX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Chlamydia Infections; Gonorrhea

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Neisseriaceae Infections

Study Officials

• Janet Wilson, MB ChB

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Harriet Wallace, MB ChB

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet Wilson, MB ChB

CONTACT

00 44 113 3920323; janet-d.wilson@nhs.net

Harriet Wallace, MB ChB

CONTACT

00 44 113 3920323; harriet.wallace@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Laboratory staff will be masked and will not be able to link pooled samples (sent under a unique study number) to comparator standard care separate samples (sent under a unique patient identifier).
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diagnostic accuracy study Single group receiving standard care plus two new comparators

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 23, 2023
• Study Start: July 18, 2023
• Primary Completion: May 29, 2024
• Study Completion: August 30, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)