Comparing doxycycline use before and after sex to prevent STIs in men who have sex with men
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
PHASE4 · Chinese University of Hong Kong · NCT06188442
This study is testing whether taking doxycycline before or after sex can help prevent bacterial STIs in men who have sex with men.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Shatin) |
| Trial ID | NCT06188442 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of doxycycline taken as on-demand pre-exposure prophylaxis (DoxyODPrEP) versus its post-exposure use (DoxyPEP) in preventing bacterial sexually transmitted infections (STIs) such as chlamydia, gonorrhea, and syphilis among men who have sex with men (MSM). Participants will be randomly assigned to one of the two groups and will follow specific dosing schedules for doxycycline while attending regular clinical follow-ups over a 24-month period. The study will assess the incidence of bacterial STIs and the safety and acceptance of doxycycline within the MSM community.
Who should consider this trial
Good fit: Ideal candidates for this study are men who have sex with men, reside in Hong Kong, and are at risk of STIs.
Not a fit: Patients who are allergic to tetracycline class medicines or currently taking contraindicated medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective method for preventing STIs in MSM, potentially reducing the incidence of these infections.
How similar studies have performed: Previous studies have explored similar approaches to STI prevention, but this specific comparison of DoxyODPrEP and DoxyPEP is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * has had sex with another male in the past six months * normally reside in Hong Kong * can communicate in written and spoken Chinese or English * willing and able to give written informed consent * being willing and able to attend scheduled study clinic visits * at risk of STI (had condomless sex with more than one man in the past 12 months, history of STI diagnosis in the past 12 months, inclination to have condomless sex, and other HIV-PrEP-eligible criteria) Exclusion Criteria: * Being allergic to tetracycline class medicines * Currently taking medications that are contraindicated with doxycycline * Using antibiotics for more than 14 days in the month preceding enrolment
Where this trial is running
Shatin
- Stanley Ho Centre for Emerging Infectious Diseases — Shatin, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Tsz Ho Kwan, PhD — Jockey Club School of Public Health and Primary Care
- Study coordinator: Secretariat
- Email: ceid@med.cuhk.edu.hk
- Phone: 22528812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sexually Transmitted Diseases, Bacterial, Syphilis, Gonorrhea, Chlamydia, doxycycline, men who have sex with men, sexually transmitted infections