Impact of the Daily Doxycycline Pre-exposure Prophylaxis (PrEP) on the Incidence of Syphilis, Gonorrhoea and Chlamydia

PHIRG1901

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

2019-12-17

2024-07-17

2024-12-17

Active (not recruiting)

100

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).

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '12 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'oropharynx and rectum swab'}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2023-10-05