- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03709459
Impact of the Daily Doxycycline Pre-exposure Prophylaxis (PrEP) on the Incidence of Syphilis, Gonorrhoea and Chlamydia (Syphilaxis)
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
Study Overview
Detailed Description
The last decade has seen increasing rates of bacterial STIs in Australia in gay and bisexual men in particular. Although STIs are easy to diagnose and treatment is effective, untreated STIs can cause significant health issues.
Previous research has shown that taking two100mg doxycycline tablets within 24 hours of sex as prophylaxis reduces syphilis and chlamydia significantly. Also a pilot trial conducted in the US suggested that using 100mg doxycycline as prophylaxis reduced the incidence of gonorrhoea, syphilis and chlamydia. Thus the question of whether taking doxycycline daily in high risk population would reduce the rate of STIs arose.
We set up this study as a non-randomized observational cohort trial using a before and after comparison to evaluate if taking 100mg doxycycline daily would help high risk gay and bisexual men to reduce the possibility of acquiring gonorrhoea, syphilis and chlamydia. Our primary objectives are to:assess acceptability of a daily dosing regimen for doxycycline prophylaxis, and measure the efficacy of 100mg daily doxycycline STI prophylaxis against reinfection with gonorrhoea, chlamydia and syphilis. Our secondary objectives are to: describe patterns of doxycycline use and medication adherence to the recommended schedule participants; evaluate change in behavioral among all study participants; evaluate resistance in the gut microbiota and in those colonized by S aureus at baseline and end of study, in a subset of consenting participants.
The study will be conducted in 3 sexual health centres. Eligible participants will undergo standard care in their trimonthly visit recommended by STI testing guideline, and complete informed consent and a baseline survey. They will be given daily dose of 100mg oral doxycycline for 3 months during the visit, and instruction of how to take the medicine. Questionnaires will be sent out to participants in every 3 months electronically and data will be collected and stored directly into the study survey database. Each participant will be follow-up for 12 months.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Yasmin Mowat, BSc
- Phone Number: +612 9385 1433
- Email: ymowat@kirby.unsw.edu.au
Study Contact Backup
- Name: Bridget Haire, PhD
- Phone Number: +612 9385 1227
- Email: b.haire@unsw.edu.au
Study Locations
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital Sexual Health Medicine
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Syd, New South Wales, Australia, 2000
- Sydney Sexual Health Centre
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Sydney, New South Wales, Australia, 2010
- Kirketon Road Centre
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Victoria
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Melbourne, Victoria, Australia, 3053
- Melbourne Sexual Health Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants
Time Frame: 1 year after the last participant complete their last follow-up visit
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measured using data collected by the ACCESS study
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1 year after the last participant complete their last follow-up visit
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Patterns of daily doxycycline use and adherence to the medication schedule
Time Frame: 1 year after the last participant complete their last follow-up visit
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measured among participants consenting to the adherence and behavioural online survey
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1 year after the last participant complete their last follow-up visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence of clinically significant antibiotic resistance in in a subset of participants
Time Frame: 1 year after the last participant who's recruited from the Melbourne site
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including those who do contract STIs during the study and those who don't
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1 year after the last participant who's recruited from the Melbourne site
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Behavioural risk practices among study participants
Time Frame: 1 year after the last participant complete their last follow-up visit
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in participants who consent to behavioral data collection online
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1 year after the last participant complete their last follow-up visit
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bridget Haire, PhD, Kirby Institute, UNSW
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Neisseriaceae Infections
- Chlamydiaceae Infections
- Sexually Transmitted Diseases, Bacterial
- Spirochaetales Infections
- Treponemal Infections
- Urogenital Diseases
- Genital Diseases
- Chlamydia Infections
- Gonorrhea
- Syphilis
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Doxycycline
Other Study ID Numbers
- PHIRG1901
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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