Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000471583
Ethics application status
Approved
Date submitted
6/03/2024
Date registered
16/04/2024
Date last updated
16/04/2024
Date data sharing statement initially provided
16/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Anorectal Chlamydia Trachomatis infection in asymptomatic women
Scientific title
Prevalence of anorectal Chlamydia Trachomatis infection in asymptomatic urogenital Chlamydia Trachomatis positive women who present to regional North Queensland Sexual Health Services.
Secondary ID [1] 311682 0
NIL
Universal Trial Number (UTN)
Trial acronym
CTIiW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chlamydia Trachomatis 333142 0
Condition category
Condition code
Infection 329841 329841 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective study will investigate and report the rates of confirmed anorectal chlamydia trachomatis (CT) infection in women who attend one of two regional North Queensland sexual health services (SHS). The research will focus on women who are confirmed to have urogenital CT infection following routine testing at the SHS, but they report no symptoms of CT prior to testing, and have not participated in any anal sexual contact in the previous six months. Participants would receive access to anal swab testing for anal CT which is not routinely given to asymptomatic women who are routinely tested for urogenital CT. Findings have potential to influence future testing and management guidelines for management of CT in this group of women. The anal swab will be conducted immediately following enrolment into the study and within 48hrs of a positive urogenital swab test (routine care). Only a single anal swab will be conducted.
Intervention code [1] 328145 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337608 0
Positive nucleic acid amplification testing for anorectal Chlamydia trachomatis
Timepoint [1] 337608 0
single time point only. Participants provide a self anal swab sample within 48 hrs of a positive test result for urogenital CT. This will be analysed in a laboratory with results within 2 days.
Primary outcome [2] 337753 0
result of the anal swab test which will be a biospecimen result which will be positive or negative for anal chlamydia.
Timepoint [2] 337753 0
Participants provide a self anal swab sample within 48 hrs of a positive test result for urogenital CT. The anal swab collection will occur at a single time point which will take approximately 20 - 30 minutes.
Secondary outcome [1] 434103 0
Treatment for dual vaginal-anal Chlamydia infection as per the Australian clinical guidelines
Timepoint [1] 434103 0
Post 7 days of Doxycycline treatment

Eligibility
Key inclusion criteria
• Community dwelling women (>18 yrs)
• Asymptomatic for any symptoms that may indicate a possible STI
• Positive for urogenital CT, identified by a swab test conducted at one of the two SHS sites in the previous 48 hours but having not commenced treatment for CT.
• Report no ASC (anal: penetration, contact with fingers, and/or sex toys, or oral contact) in the previous six months.
• Willing, and able to understand and complete all procedures related to their ‘usual clinical care’.
• Willing, and able to understand and provide written informed consent to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individuals who report any symptoms indicative of a STI including but not limited to:
Dysuria,
Dyspareunia,
Vaginal or rectal discharge,
Pelvic or rectal pain,
Intermenstrual, post coital, or rectal bleeding
• Individuals who have already commenced treatment for the current chlamydia infection
• Inability or unwillingness to provide written consent.
• Men, or men who are transitioning to women
• Transgender or gender diverse people

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The estimated study sample size was calculated based on the number of cases of chlamydia trachomatis (CT) notified to the Hospital and Health services of the study sites. Based on previous evidence females represented 56.1% of notified CT cases in Queensland, and at least 70% of these women were estimated to be asymptomatic. Supported by data from a previous international study, a conservative assumption that 50% of the study participants will test positive for concurrent urogenital and anorectal CT was applied. Given a 95% confidence interval (CI), a sample size of 290 was calculated.
Descriptive analysis of the demographics of participants will be undertaken, with reporting as mean and standard deviation, or median and inter-quartile range, as appropriate. The proportion (%) of all participants who test +ve for anal CT will be calculated (concurrent urogenital and anorectal).
To achieve the primary study objective, statistical analysis to calculate the point prevalence of anorectal CT infection within the urogenital CT infected sample population will be calculated using a proportional based analysis of the study sample, to give a probability estimate that women in the study population had anorectal CT at the given point in time. Using the following formula where P is the number of participants in the sample with anorectal CT infection (concurrent infection), divided by the total number of participants (all urogenital CT infected) in the sample.
Prevalence = Number of anorectal CT infected asymptomatic women with no reported anal sexual contact (cases) /Total number of urogenital CT infected asymptomatic women with no reported anal sexual contact (sample population).
Some sub-group analysis for prevalence may be performed according to age groups if sufficient study power allows for statistical inference to be drawn at the time of analysis. Analysis will be conducted using the Statistical Package for the Social Sciences (SPSS©) version 28.

.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/04/2024
Date of last participant enrolment
Anticipated
31/03/2027
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
290
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26239 0
Townsville Sexual Health Services - North Ward
Recruitment hospital [2] 26240 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 42207 0
4810 - North Ward
Recruitment postcode(s) [2] 42208 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 316009 0
Government body
Name [1] 316009 0
Townsville Hospital and Health Services
Country [1] 316009 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
Country
Australia
Secondary sponsor category [1] 318161 0
Government body
Name [1] 318161 0
Mackay Hospital and Health Services
Address [1] 318161 0
Country [1] 318161 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314834 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314834 0
Ethics committee country [1] 314834 0
Australia
Date submitted for ethics approval [1] 314834 0
27/04/2023
Approval date [1] 314834 0
28/07/2023
Ethics approval number [1] 314834 0
HREC/2023/QTHS/94555
Ethics committee name [2] 314835 0
James Cook University Human Research Ethics Committee
Ethics committee address [2] 314835 0
Ethics committee country [2] 314835 0
Australia
Date submitted for ethics approval [2] 314835 0
26/02/2024
Approval date [2] 314835 0
18/03/2024
Ethics approval number [2] 314835 0
H9417

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132874 0
Dr Carol Ann Flavell
Address 132874 0
Rm 013, Building 43 James Cook University, Townsville , QLD 4811
Country 132874 0
Australia
Phone 132874 0
+61 747816472
Fax 132874 0
Email 132874 0
[email protected]
Contact person for public queries
Name 132875 0
Carol Ann Flavell
Address 132875 0
Rm 013, Building 43 James Cook University, Townsville QLD 4811
Country 132875 0
Australia
Phone 132875 0
+61 747816472
Fax 132875 0
Email 132875 0
[email protected]
Contact person for scientific queries
Name 132876 0
Carol Ann Flavell
Address 132876 0
Rm 013, Building 43 James Cook University, Townsville QLD 4811
Country 132876 0
Australia
Phone 132876 0
+61 747816472
Fax 132876 0
Email 132876 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
confidential patient information


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.