Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001584426p
Ethics application status
Not yet submitted
Date submitted
14/11/2016
Date registered
16/11/2016
Date last updated
29/11/2019
Date data sharing statement initially provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of antibiotic treatment regimen on sexual behaviour following urogenital Chlamydia trachomatis infection
Scientific title
Impact of antibiotic treatment regimen (azithromycin 1g single dose vs doxycycline 100mg twice daily for 7 days) on sexual behavior following urogenital Chlamydia trachomatis infection among heterosexuals – an open label randomised controlled trial
Secondary ID [1] 290534 0
None
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chlamydia trachomatis 300958 0
Condition category
Condition code
Infection 300759 300759 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Azithromycin (1g single dose, oral tablet) to be taken under observation.
Intervention code [1] 296389 0
Treatment: Drugs
Comparator / control treatment
Doxycycline (100mg, oral tablet, twice daily for 7 days).

Participants will be asked to complete a validated questionnaire about drug adherence at the end of the week. They will also be asked to return the blister pack for pill count as a proxy measure of drug compliance.
Control group
Active

Outcomes
Primary outcome [1] 300178 0
Primary outcome will be "sexual intercourse in the last 24 hours- yes/no" with sexual intercourse defined as "penile/vaginal insertion".

Although the definition for sexual intercourse is very broad, the study will be limited to urogenital infection among heterosexuals.

Starting 24 hours since starting treatment, participants will be sent daily short message service (SMS) that ask the following question: "In the last 24 hours, did you have any sexual intercourse? Yes/No" for 1 week at 24 hour intervals.
Timepoint [1] 300178 0
7 days (168 hours) after start of treatment therapy.

By the primary timepoint, we will have a total of 7 daily measures of the primary outcome representing total sexual activity over a 1 week period.
Secondary outcome [1] 329253 0
Time to first report "sexual intercourse in the last 24 hours -yes".
Timepoint [1] 329253 0
Secondary timepoint will measure time elapse from start of treatment to first sexual activity.

This is a measure of how soon participants re-engage in sexual activity following start of treatment.

Eligibility
Key inclusion criteria
Heterosexual patients diagnosed positive for asymptomatic urogential chlamydia by nucleic acid amplification test.

Adequate English and comprehension skills to give consent

Willing and able to answer to survey questions by SMS.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluced if they are:
they are concurrently diagnosed with another bacterial STI;
have known contraindications to trial medications;
present with symptomatic urethritis or pelvic inflammatory disease;
are currently engaged in commercial sex work;
or are pregnant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed as the objective of the study is to investigate the influence of different treatment regimen on patients' sexual behaviour.

Measurement bias is limited as the outcome (sexual intercourse in last 24 hours) is self-reported and binary.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed to manage selection bias between treatment arms.

A computer-generated randomisation sequence will be created by an independent statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant demographics will be compared using Pearson’s Chi square test to examine exchangeability between study arms. The proportion who report sexual intercourse during follow up will be calculated using exact binomial methods and compared between treatment groups using a Chi square test. Time to first self-report of sexual intercourse will be examined using survival analysis to generate hazard ratios.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Trial not started and cancelled.
Date of first participant enrolment
Anticipated
1/02/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 14605 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 294961 0
Government body
Name [1] 294961 0
National Health and Medical Research Council (NHMRC) Program Grant
Country [1] 294961 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Level 3, 207 Bouverie St
Carlton South, Victoria, 3053
Country
Australia
Secondary sponsor category [1] 293782 0
None
Name [1] 293782 0
Address [1] 293782 0
Country [1] 293782 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296322 0
Alfred Helath Human Ethics Committee
Ethics committee address [1] 296322 0
Alfred Hospital
55 Commercial rd.
Melbourne, VIC 3004
Ethics committee country [1] 296322 0
Australia
Date submitted for ethics approval [1] 296322 0
11/01/2017
Approval date [1] 296322 0
Ethics approval number [1] 296322 0

Summary
Brief summary
Azithromycin and doxycycline are antibiotics that are widely used in the management of sexually transmissible infections (STIs). STI management guidelines in Australia, the UK and US all recommend the use of azithromycin (1g single dose, orally) or doxycycline (100mg, orally, twice daily for 7 days) for uncomplicated urogenital chlamydia with the former preferred for its ease of dose and minimalisation of non-adherence.
The most recent meta-analysis shows that the regimens are comparable with only a marginal increase (3%) in efficacy in favour of doxycycline over azithromycin.

However, it has been hypothesised that treatment regimen may influence patient’s sexual behavior, placing them at increased risk of early re-infection. Patients on doxycycline – a 7-day daily regimen, may be more mindful of their infection status because they need to take a daily dose and may not re-engage in unprotected sex until dosage is completed.

On the other hand, those on single dose regimens may feel more confident that their condition has been treated or may forget about their infection and may re-engage in sexual activity earlier than those taking doxycycline, potentially making them more at risk of re-infection.
To our knowledge, this has never been formally studied and represents a knowledge gap in the literature, necessitating this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70222 0
Prof Jane Hocking
Address 70222 0
University of Melbourne
Level 3, 207 Bouverie St
Carlton South, 3053
VIC, Australia
Country 70222 0
Australia
Phone 70222 0
+61 3 8344 0762
Fax 70222 0
Email 70222 0
[email protected]
Contact person for public queries
Name 70223 0
Prof Jane Hocking
Address 70223 0
University of Melbourne
Level 3, 207 Bouverie St
Carlton South, 3053
VIC, Australia
Country 70223 0
Australia
Phone 70223 0
+61 3 8344 0762
Fax 70223 0
Email 70223 0
[email protected]
Contact person for scientific queries
Name 70224 0
Prof Jane Hocking
Address 70224 0
University of Melbourne
Level 3, 207 Bouverie St
Carlton South, 3053
VIC, Australia
Country 70224 0
Australia
Phone 70224 0
+61 3 8344 0762
Fax 70224 0
Email 70224 0
[email protected]

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


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.