Impact of the Daily Doxycycline Pre-exposure Prophylaxis (PrEP) on the Incidence of Syphilis, Gonorrhoea and Chlamydia (Syphilaxis)
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| ClinicalTrials.gov Identifier: NCT03709459 |
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Recruitment Status :
Recruiting
First Posted : October 17, 2018
Last Update Posted : April 1, 2022
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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
| Condition or disease | Intervention/treatment |
|---|---|
| STIs Prevention | Drug: Doxycycline |
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 : | Observational [Patient Registry] |
| Estimated Enrollment : | 125 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 12 Months |
| Official Title: | Impact of the Daily Doxycycline Pre-exposure Prophylaxis (PrEP) on the Incidence of Syphilis, Gonorrhoea and Chlamydia |
| Actual Study Start Date : | December 17, 2019 |
| Estimated Primary Completion Date : | December 17, 2024 |
| Estimated Study Completion Date : | December 17, 2024 |
- Drug: Doxycycline
Participants will be asked to take Doxycycline 100mg/day for 12months duration
- 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
- 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 ]including those who do contract STIs during the study and those who don't
- Behavioural risk practices among study participants [ Time Frame: 1 year after the last participant complete their last follow-up visit ]in participants who consent to behavioral data collection online
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709459
| Contact: Yasmin Mowat, BSc | +612 9385 1433 | ymowat@kirby.unsw.edu.au | |
| Contact: Bridget Haire, PhD | +612 9385 1227 | b.haire@unsw.edu.au |
| Australia, New South Wales | |
| Royal Prince Alfred Hospital Sexual Health Medicine | Not yet recruiting |
| Camperdown, New South Wales, Australia, 2050 | |
| Contact: Linda Garton 02 9515 1200 Linda.Garton@health.nsw.gov.au | |
| Contact: David Templeton 02 9515 1200 David.Templeton@health.nsw.gov.au | |
| Kirketon Road Centre | Recruiting |
| Sydney, New South Wales, Australia, 2010 | |
| Contact: Dr Phillip Read 02 9360 2766 phillip.read1@health.nsw.gov.au | |
| Principal Investigator: Dr Phillip Read | |
| Sydney Sexual Health Centre | Recruiting |
| Syd, New South Wales, Australia, 2000 | |
| Contact: Dr Anna McNulty 02 9382 7476 anna.mcnulty@health.nsw.gov.au | |
| Principal Investigator: Dr Anna McNulty | |
| Australia, Victoria | |
| Melbourne Sexual Health Centre | Recruiting |
| Melbourne, Victoria, Australia, 3053 | |
| Contact: Dr Eric Chow 03 9341 6233 EChow@mshc.org.au | |
| Principal Investigator: Dr Eric Chow | |
| Sub-Investigator: Professor Christopher K Fairley | |
| Principal Investigator: | Bridget Haire, PhD | Kirby Institute, UNSW |
| Responsible Party: | Kirby Institute |
| ClinicalTrials.gov Identifier: | NCT03709459 |
| Other Study ID Numbers: |
PHIRG1901 |
| First Posted: | October 17, 2018 Key Record Dates |
| Last Update Posted: | April 1, 2022 |
| Last Verified: | March 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Syphilis, Gonorrhea, Chlamydia, Doxycycline, PrEP, Syphilaxis |
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Doxycycline Chlamydia Infections Gonorrhea Syphilis Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases |
Communicable Diseases Genital Diseases Urogenital Diseases Neisseriaceae Infections Treponemal Infections Spirochaetales Infections Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |