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

NCT06188442 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-04-04

No results posted yet for this study

Summary

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.

Conditions

  • Sexually Transmitted Diseases, Bacterial
  • Syphilis
  • Gonorrhea
  • Chlamydia

Interventions

DRUG

DoxyODPrEP

Participants in the DoxyODPrEP arm would be instructed to take two doxycycline hyclate 100mg capsules orally 2-24 hours before sex, and one 100mg capsule each 24 and 48 hours after loading dose. If they have sex within 48 hours after the loading dose, they would be asked to continue a daily 100mg until two days after the last sex

DRUG

DoxyPEP

Participants in the DoxyPEP arm would be instructed to take two doxycycline hyclate 100mg capsules orally within 24 hours and up to 72 hours after each sex.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Tsz Ho Kwan, PhD · Jockey Club School of Public Health and Primary Care

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-29
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06188442 on ClinicalTrials.gov