ChlamydiaMYSTICNCT05870098
Meatal Swab Yourself With Testing for Infections Collectively
A study testing All participants in people with Chlamydia and Gonorrhea, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- All participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jul 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over. Willing to perform self-taken swabs in addition to any clinician required swabs. Able to provide informed consent
Who cannot join
- Antibiotics taken in the past 14 days (excluding metronidazole). Previous participation in this trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS1 3EX
Janet Wilson, MB ChB, 00 44 113 3920323, janet-d.wilson@nhs.net
Harriet Wallace, MB ChB, 00 44 113 3920323, harriet.wallace@nhs.net
About this study
Official title: Meatal Swab Yourself With Testing for Infections Collectively (MYSTIC)
The goal of this study is
- 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
- to assess the diagnostic accuracy of pooled specimens for lymphogranuloma venereum detection (LGV) - a type of chlamydia infection
Read more
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.
Read the detailed description
Testing for chlamydia and gonorrhoea in men who have sex with men (MSM) and trans-women is recommended every three months for those taking HIV Pre-Exposure Prophylaxis (PrEP). Testing requires throat and bottom samples, and samples from the urethra (wee-pipe), usually a urine sample. However, many sexual health services struggle to afford the costs of these 3-samples, four-times per year, which may restrict numbers given PrEP.
The investigators' previous research has shown that the 3-samples (throat, bottom, urine) can be combined into one pooled specimen to accurately find gonorrhoea and reduce laboratory costs. However, the chlamydia results of pooled samples were not as good, finding only 92 out of 100 infections compared with 99 out of 100 with 3 separate samples. The investigators' past research showed no difference in diagnostic accuracy between clinician and self-taken rectum and pharynx swabs for NG and CT detection. People prefer to take their own swabs and self-taken swabs were more cost effective than clinician taken. Self-taken swabs are now used routinely in clinical practice and are available as on-line ordered commercial kits.
This study aims to improve the accuracy of chlamydia results by comparing two new pooling methods with the 3-samples tested separately.
MSM, and trans-women, aged 18 years or over, attending a large UK city sexual health service for chlamydia and gonorrhoea testing will be invited to take part in the study.
The pooling methods will be: 1) pooling with a smaller amount of urine to reduce the dilution of the other samples; and 2) pooling with a swab sample from the outside of the tip of the penis (meatal swab) instead of urine. Meatal swabs are taken by the person themselves. The swab does not go inside the penis so is easy to do and not painful. Studies suggest meatal swabs may be better at finding chlamydia than urine samples.
To ensure an accurate comparison, the order of taking the two pooling method samples, and the 3-samples tested separately, will be randomised.
The study will recruit 1250 participants. This is a large enough number to show if either of the pooling methods can detect more chlamydia than 92 out of 100 infections.
If a pooling technique was developed for MSM and trans-women that did not reduce diagnostic sensitivity, this would likely be implemented. A sensitive, low-cost, method of triple-site STI testing, available on-line, or using minimal in-house staff, would enable increased testing. The investigators believe this study will identify such a method by using meatal swabs or a reduced urine volume. The reduced diagnostic costs of almost two-thirds would enable sexual health clinics to provide PrEP to more people, and/or utilise the money saved elsewhere in their service.
- Being tested
- All participants
- Medical subject headings
- Chlamydia Infections, Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All participantsDiagnostic test
- Clinician or self-taken, pharyngeal and rectal swabs with FCU analysed individually
- Self-taken pharyngeal, meatal, and rectal swabs analysed as a pooled specimen
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: All participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
To assess participant satisfaction with using self-taken meatal swabs compared with FCU, participants will complete a questionnaire following their self sampling. Satisfaction will be assessed using a 5 point Likert scale, checking for ease of use, discomfort when sampling, and belief in validity of results.
Measured: 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
To assess participant satisfaction with taking and pooling combined site samples compared with individually analysed samples, participants will complete a questionnaire following their self sampling. Satisfaction will be assessed using a 5 point Likert scale, checking for ease of process, clarity of instructions, and belief in validity of results.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start18 Jul 2023
- Primary completion29 May 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChlamydiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Diagnostic accuracy study Single group receiving standard care plus two new comparators
- Masking
- None (open label)
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet Wilson, MB ChB, Principal investigator, Leeds Teaching Hospitals NHS TrustHarriet Wallace, MB ChB, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870098
- Sponsor's protocol ID
- GU19-125925
- Acronym
- MYSTIC
- Status last verified
- Dec 2023
- First submitted
- 28 Apr 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meatal Swab Yourself With Testing for Infections Collectively (MYSTIC)
- ClinicalTrials.gov ID
- NCT05870098
- Acronym / sponsor ID
- MYSTIC / GU19-125925
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 29 May 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is
- 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
- 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.
Detailed description
Testing for chlamydia and gonorrhoea in men who have sex with men (MSM) and trans-women is recommended every three months for those taking HIV Pre-Exposure Prophylaxis (PrEP). Testing requires throat and bottom samples, and samples from the urethra (wee-pipe), usually a urine sample. However, many sexual health services struggle to afford the costs of these 3-samples, four-times per year, which may restrict numbers given PrEP.
The investigators' previous research has shown that the 3-samples (throat, bottom, urine) can be combined into one pooled specimen to accurately find gonorrhoea and reduce laboratory costs. However, the chlamydia results of pooled samples were not as good, finding only 92 out of 100 infections compared with 99 out of 100 with 3 separate samples. The investigators' past research showed no difference in diagnostic accuracy between clinician and self-taken rectum and pharynx swabs for NG and CT detection. People prefer to take their own swabs and self-taken swabs were more cost effective than clinician taken. Self-taken swabs are now used routinely in clinical practice and are available as on-line ordered commercial kits.
This study aims to improve the accuracy of chlamydia results by comparing two new pooling methods with the 3-samples tested separately.
MSM, and trans-women, aged 18 years or over, attending a large UK city sexual health service for chlamydia and gonorrhoea testing will be invited to take part in the study.
The pooling methods will be: 1) pooling with a smaller amount of urine to reduce the dilution of the other samples; and 2) pooling with a swab sample from the outside of the tip of the penis (meatal swab) instead of urine. Meatal swabs are taken by the person themselves. The swab does not go inside the penis so is easy to do and not painful. Studies suggest meatal swabs may be better at finding chlamydia than urine samples.
To ensure an accurate comparison, the order of taking the two pooling method samples, and the 3-samples tested separately, will be randomised.
The study will recruit 1250 participants. This is a large enough number to show if either of the pooling methods can detect more chlamydia than 92 out of 100 infections.
If a pooling technique was developed for MSM and trans-women that did not reduce diagnostic sensitivity, this would likely be implemented. A sensitive, low-cost, method of triple-site STI testing, available on-line, or using minimal in-house staff, would enable increased testing. The investigators believe this study will identify such a method by using meatal swabs or a reduced urine volume. The reduced diagnostic costs of almost two-thirds would enable sexual health clinics to provide PrEP to more people, and/or utilise the money saved elsewhere in their service.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Diagnostic accuracy study Single group receiving standard care plus two new comparators
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Diagnostic Test: All participantsAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years and over. Willing to perform self-taken swabs in addition to any clinician required swabs. Able to provide informed consent
Key exclusion criteria (1 listed)
- Antibiotics taken in the past 14 days (excluding metronidazole). Previous participation in this trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All participants1. 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 |
Primary outcome
Sensitivity and specificity for gonorrhoea, chlamydia and LGV diagnosis using NAATS
Time frame: 14 months
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
2 secondary outcomes
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
Time frame: 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
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Chlamydia
RecruitingPhase 1
Phase 1 Study of Chlamydia Trachomatis mRNA Vaccine in Adults.
Chlamydia Trachomatis Immunization
Active, not recruitingPhase 4
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Gonorrhea Male, Chlamydia (Male)
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Not yet recruiting
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
HIV, Syphilis
Not yet recruitingPhase 3
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
Sexually Transmitted Infection (STI), Gonorrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Wilson, MB ChB principal investigator
Leeds Teaching Hospitals NHS Trust
Harriet Wallace, MB ChB principal investigator
Leeds Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All participants in people with Chlamydia and Gonorrhea, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janet Wilson, MB ChB (00 44 113 3920323, janet-d.wilson@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity for gonorrhoea, chlamydia and LGV diagnosis using NAATS (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.