NCT06188442

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

Superiority of On-demand Pre-exposure Prophylaxis Versus Post-exposure Prophylaxis on Using Doxycycline for Preventing Sexually Transmitted Infections in Men Who Have Sex With Men

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants would be randomly assigned to either DoxyODPrEP or DoxyPEP arm, and be instructed to take doxycycline with the respective dosing schedule. They would be followed up for 24 months for nucleic acid amplification test (NAAT) and antibody tests against bacterial STI, namely chlamydia, gonorrhoea, and syphilis. The subjects and investigators would not be blinded due to its open-label nature, as the two arms' dosing schedules are different. 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. 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. At each clinic visit, urine, and pharyngeal and rectal swabs would be self-collected on-site by the participants following instructions. Pill count would be performed for each follow-up visit.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-29
• Primary completion: 2027-12-31
• Completion: 2028-12-01
• First posted: 2024-01-03
• Last updated: 2025-04-04

Locations

1 site across 1 country: Hong Kong