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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other
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
1. This study is a non-randomized observational cohort trial using before and after
comparison to evaluate intervention 2. It would mimic the conditions that would occur outside
a clinical trial. 2. After consent and enrolment, all procedures will be guided by the
Australian STI Management Guidelines.

3. All enrolling participants will be offered daily doxycycline 100mg 4. All participants
will be invited to complete a survey in every 3 months time for 12 months dated from
participation.

5. All follow-up information will be collected through electronic data capture to allow
accurate and timely analyses.

6. Data collection will be from (i) medical records (ii) online self-completed questionnaire
Trial website
https://clinicaltrials.gov/ct2/show/NCT03709459
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03709459