NCT04244994

Brief Summary

Objectives: To compare self-taken penile meatal swabs versus first-catch urine samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium from the penile urethra using nucleic acid amplification tests. To assess the acceptability of self-taken penile meatal swabs compared with first-catch urine samples. To assess the prevalence of Mycoplasma genitalium in those with urethritis. To assess the prevalence of Mycoplasma genitalium antimicrobial resistance. To evaluate the utility of using Mycoplasma genitalium resistance-guided therapy. To compare the cost of using self-taken penile meatal swabs versus FCU samples for the correct detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium. Methods: Men and transwomen presenting for a sexual health screen will perform a self-taken penile meatal swab followed by a first-catch urine (FCU) sample. Both will be analysed using the Aptima Combo 2 test (Hologic, San Diego, California \[CA\], USA) for chlamydia and gonorrhoea. In those with urethritis they will also be analysed using Aptima MGen test for Mycoplasma genitalium. Details of demographics, past history, sexual history, clinical symptoms and signs will be collected. The acceptability of each sample will be assessed using a patient questionnaire. The samples of those infected with Mycoplasma genitalium will be tested for Mycoplasma genitalium macrolide and fluoroquinolone resistance mutations by in-house polymerase chain reaction (PCR) using Sanger sequencing to characterise mutants in the 23s gene for macrolide resistance and DNA gyrase subunit A (gyrA) and DNA topoisomerase IV subunit C (parC) genes for fluoroquinolone resistance. The result of this will be used to guide the therapy prescribed to treat the infection. Primary outcome: Sensitivity, specificity, positive and negative predictive values of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium in the penile urethra. Secondary outcomes: Acceptability of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium. Prevalence of Mycoplasma genitalium in those with urethritis. Prevalence of Mycoplasma genitalium antimicrobial resistance. Utility of using Mycoplasma genitalium resistance-guided therapy. Cost of using self-taken penile meatal swabs versus FCU samples for the correct detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

November 22, 2019

Last Update Submit

January 24, 2020

Conditions

Sexually Transmitted Diseases, Bacterial

Keywords

Chlamydia trachomatisNeisseria gonorrhoeaeMycoplasma genitalium

Outcome Measures

Primary Outcomes (1)

  • Sensitivities, specificities, positive and negative predictive values

    Sensitivity, specificity, positive and negative predictive values of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium in the penile urethra.

    At time of enrollment

Secondary Outcomes (5)

  • Participant reported acceptability of self-taken penile meatal swabs compared with FCU samples for the detection of chlamydia, gonorrhoea and Mycoplasma genitalium.

    At time of enrollment

  • Prevalence of Mycoplasma genitalium in those with urethritis.

    At time of enrollment

  • Prevalence of Mycoplasma genitalium antimicrobial resistance.

    At time of enrollment

  • Utility of using Mycoplasma genitalium resistance-guided therapy to prevent inappropriate antibiotic use.

    6 months after enrollment

  • Cost comparison

    At time of enrollment

Study Arms (1)

Intervention and Control

OTHER

Self-taken penile meatal swabs versus first-catch urine for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium using Aptima-Combo2 and Aptima Mgen

Device: Aptima-Combo2 and Aptima Mgen

Interventions

Aptima-Combo2 and Aptima MgenDEVICE

Self-taken penile meatal swabs versus first-catch urine samples for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium using Aptima-Combo2 and Aptima Mgen

Intervention and Control

Eligibility Criteria

Age18 Years - 99 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales and trans-women with male genitalia
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and transwomen who have male genitalia
  • Aged 18 and over
  • Ever sexually active
  • Presenting to Leeds Sexual Health wishing to be tested for chlamydia, gonorrhoea and M. genitalium (if symptoms of urethritis are present)
  • Give verbal consent

You may not qualify if:

  • Never sexually active
  • Non-male genitalia
  • Unwilling to give verbal consent
  • Unwilling to perform a self-taken penile meatal swab and unwilling/unable to perform a first-catch urine sample
  • Having taken antibiotics (other than metronidazole) in the past 14 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Janet Wilson, MB ChB

CONTACT

00 44 0113 3920323janet-d.wilson@nhs.net

Michelle Loftus-Keeling

CONTACT

00 44 113 3920323michelle.loftus-keeling@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Comparison of self-taken penile meatal swabs (intervention) versus first-catch urine (control) for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium in all participants
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2019

First Posted

January 28, 2020

Study Start

April 1, 2020

Primary Completion

August 1, 2021

Study Completion

April 1, 2022

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)