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Superiority of On-demand PrEP Versus PEP on Using Doxycycline for Preventing STI in MSM

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 2026 to Dec 31, 2027 · Start date changed from estimate of Apr 2024 to Mar 29, 2025 · Completion date: Mar 2027 to Dec 2028 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Oct 2026 to Dec 31, 2027
    • Start date changed from estimate of Apr 2024 to Mar 29, 2025
    • Completion date: Mar 2027 to Dec 2028
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare the effectiveness of doxycycline taken for on-demand pre-exposure prophylaxis (DoxyODPrEP) and its post-exposure use (DoxyPEP) in preventing bacterial sexually transmitted infections (STI), including chlamydia, gonorrhoea, and syphilis among men who have sex with men (MSM). The main questions it aims to answer are: 1. Is DoxyODPrEP superior to DoxyPEP? 2. Are both regimens safe? 3. Does the MSM community accept the use of doxycycline to prevent bacterial STI? Participants will be asked to take doxycycline according to the study arm they are randomly assigned to, and attend regular clinical follow-ups during the 2-year observation period. Researchers will compare the bacterial STI incidences between the two groups to see if DoxyODPrEP is superior to DoxyPEP.
Trial Details
NCT Number NCT06188442
Lead Sponsor Chinese University of Hong Kong
Conditions Sexually Transmitted Diseases, Bacterial, Syphilis, Gonorrhea, Chlamydia
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov