Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03709459




Registration number
NCT03709459
Ethics application status
Date submitted
12/10/2018
Date registered
17/10/2018
Date last updated
5/10/2023

Titles & IDs
Public title
Impact of the Daily Doxycycline Pre-exposure Prophylaxis (PrEP) on the Incidence of Syphilis, Gonorrhoea and Chlamydia
Scientific title
Impact of the Daily Doxycycline Pre-exposure Prophylaxis (PrEP) on the Incidence of Syphilis, Gonorrhoea and Chlamydia
Secondary ID [1] 0 0
PHIRG1901
Universal Trial Number (UTN)
Trial acronym
Syphilaxis
Linked study record

Health condition
Health condition(s) or problem(s) studied:
STIs Prevention 0 0
Condition category
Condition code
Infection 0 0 0 0
Sexually transmitted infections
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Doxycycline

Treatment: Drugs: Doxycycline
Participants will be asked to take Doxycycline 100mg/day for 12months duration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants
Timepoint [1] 0 0
1 year after the last participant complete their last follow-up visit
Primary outcome [2] 0 0
Patterns of daily doxycycline use and adherence to the medication schedule
Timepoint [2] 0 0
1 year after the last participant complete their last follow-up visit
Secondary outcome [1] 0 0
Evidence of clinically significant antibiotic resistance in in a subset of participants
Timepoint [1] 0 0
1 year after the last participant who's recruited from the Melbourne site
Secondary outcome [2] 0 0
Behavioural risk practices among study participants
Timepoint [2] 0 0
1 year after the last participant complete their last follow-up visit

Eligibility
Key inclusion criteria
* Male or transgender
* Aged 18 years or over
* Reports sex with men in last 3 months
* At least two screenings for syphilis, gonorrhoea and chlamydia in the past 12 months
* A diagnosis of syphilis within the last 12 months, OR a diagnosis of any 2 STIs within the last 12 months and syphilis within the last 24 months.
* HIV +ve, OR HIV -ve and on PrEP for at least 6 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Documented or self-reported hypersensitivity to doxycycline or antimicrobial agents from tetracycline family
* A known diagnosis of myasthenia gravis
* Factors or conditions that may compromise a participant's access to health services for follow-up (incarceration or planned relocation that would impact upon proximity to a trial site).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/12/2024
Actual
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital Sexual Health Medicine - Camperdown
Recruitment hospital [2] 0 0
Kirketon Road Centre - Sydney
Recruitment hospital [3] 0 0
Sydney Sexual Health Centre - Syd
Recruitment hospital [4] 0 0
Melbourne Sexual Health Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2000 - Syd
Recruitment postcode(s) [4] 0 0
3053 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
South Australian Health and Medical Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bridget Haire, PhD
Address 0 0
Kirby Institute, UNSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03709459