Preventing bacterial STIs in high-risk MSM and TGW using doxycycline and vaccination
Doxycycline PEP and 4CMenB as a Comprehensive Prevention Strategy in MSM and TGW at High Risk for Bacterial STIs Within the Swiss HIV Cohort Study
This study is testing if giving doxycycline and a specific vaccine can help prevent bacterial STIs in high-risk men who have sex with men and transgender women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT06242730 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of offering event-driven doxycycline post-exposure prophylaxis (PEP) and 4CMenB immunization to men who have sex with men (MSM) and transgender women (TGW) at high risk for bacterial sexually transmitted infections (STIs). Participants from the Swiss HIV Cohort Study who meet specific criteria will be offered this prevention package, and the incidence of STIs will be compared between those who accept and those who decline the intervention over a 12-month period. Additionally, the study includes sub-studies investigating the impact of doxycycline PEP on the microbiome and antibiotic resistance patterns.
Who should consider this trial
Good fit: Ideal candidates include MSM and TGW aged 18 and older who are part of the Swiss HIV Cohort Study and have a history of bacterial STIs or condomless sex.
Not a fit: Patients who are not part of the Swiss HIV Cohort Study or have contraindications to doxycycline or 4CMenB will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of bacterial STIs among high-risk populations.
How similar studies have performed: Other studies have shown promise in using doxycycline for STI prevention, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ≥ 18 years of age * Participant in the SHCS * On antiretroviral therapy with suppressed viral load for ≥ 3 months * MSM or TGW * ≥ 1 bacterial STI (syphilis, CT, MG, or NG) within the past 3 years and/or reporting condomless sex with ≥ 1 occasional partner within the last 6 months * Consenting for off-label use of doxycycline as PEP and/or 4CMenB for the prevention of bacterial STIs * No allergy or intolerance to doxycycline or 4CMenB * No other contraindication for doxycycline (e. g. co-medication) Exclusion Criteria: * Not participating in the SHCS
Where this trial is running
Zurich
- University Hospital Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Dominique L Braun, MD
- Email: dominique.braun@usz.ch
- Phone: 0041442559196
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.