Superiority of On-demand PrEP Versus PEP on Using Doxycycline for

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Chlamydia
Gonorrhea
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Syphilis

Clinical Trial Details

NCT number	NCT06188442
Study type	Interventional
Source	Chinese University of Hong Kong
Contact	Secretariat
Phone	22528812
Email	ceid@med.cuhk.edu.hk
Status	Not yet recruiting
Phase	Phase 4
Start date	April 2024
Completion date	March 2027

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms