STIs PreventionSyphilaxisNCT03709459
Impact of the Daily Doxycycline Pre-exposure Prophylaxis (PrEP) on the Incidence of Syphilis, Gonorrhoea and Chlamydia
An observational study of STIs Prevention, run by Kirby Institute at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- STIs Prevention
- What is being tested?
- Doxycycline
- How many people
- 100 participants
- Where
- 4 sitesAustralia
- Study dates
- 17 Dec 2019to 17 Dec 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men who report male to male sex in the last 3 months and who have had at least two screening for syphilis, chlamydia and gonorrhoea in the last 12 months, and at least once incidence of syphilis in the last two years, are eligible for the study.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Royal Prince Alfred Hospital Sexual Health Medicine
Camperdown, New South Wales, 2050
Melbourne Sexual Health Centre
Melbourne, Victoria, 3053
Sydney Sexual Health Centre
Sydney, New South Wales, 2000
Kirketon Road Centre
Sydney, New South Wales, 2010
About this study
- 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.
- 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.
- All follow-up information will be collected through electronic data capture to allow accurate and timely analyses.
- Data collection will be from (i) medical records (ii) online self-completed questionnaire
Read the 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.
- Conditions
- STIs Prevention
- Being tested
- Doxycycline
- Keywords
- Syphilis, Gonorrhea, Chlamydia, Doxycycline, PrEP, Syphilaxis
- Medical subject headings
- Syphilis, Gonorrhea, Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Participants will be asked to take Doxycycline 100mg/day for 12months duration
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person years among study participants
measured using data collected by the ACCESS study
Measured: 1 year after the last participant complete their last follow-up visit
Patterns of daily doxycycline use and adherence to the medication schedule
measured among participants consenting to the adherence and behavioural online survey
Measured: 1 year after the last participant complete their last follow-up visit
Secondary outcomes (2)
Evidence of clinically significant antibiotic resistance in in a subset of participants
including those who do contract STIs during the study and those who don't
Measured: 1 year after the last participant who's recruited from the Melbourne site
Behavioural risk practices among study participants
in participants who consent to behavioral data collection online
Measured: 1 year after the last participant complete their last follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start17 Dec 2019
- Primary completion17 Jul 2024 (estimated)
- Study completion17 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STIs PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- South Australian Health and Medical Research Institute, Monash University
- Responsible party
- Sponsor
- Investigators
- Bridget Haire, PhD, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709459
- Sponsor's protocol ID
- PHIRG1901
- Acronym
- Syphilaxis
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2018
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Daily Doxycycline Pre-exposure Prophylaxis (PrEP) on the Incidence of Syphilis, Gonorrhoea and Chlamydia
- ClinicalTrials.gov ID
- NCT03709459
- Acronym / sponsor ID
- Syphilaxis / PHIRG1901
- Conditions
- STIs Prevention
- Keywords
- Syphilis, Gonorrhea, Chlamydia, Doxycycline, PrEP, Syphilaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- South Australian Health and Medical Research Institute, Monash University
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 17 Jul 2024 (estimated)
- Study completion
- 17 Dec 2024 (estimated)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- All follow-up information will be collected through electronic data capture to allow accurate and timely analyses.
- Data collection will be from (i) medical records (ii) online self-completed questionnaire
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men who report male to male sex in the last 3 months and who have had at least two screening for syphilis, chlamydia and gonorrhoea in the last 12 months, and at least once incidence of syphilis in the last two years, are eligible for the study.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineParticipants will be asked to take Doxycycline 100mg/day for 12months duration | Drug | – |
Primary outcome
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
measured using data collected by the ACCESS study
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
measured among participants consenting to the adherence and behavioural online survey
2 secondary outcomes
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
Behavioural risk practices among study participants
Time frame: 1 year after the last participant complete their last follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
Related trials for STIs Prevention
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bridget Haire, PhD principal investigator
Kirby Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STIs Prevention, run by Kirby Institute at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.