Doxycycline STI PEPDOXY-MENNCT06242730
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
An observational study of Doxycycline STI PEP, run by University of Zurich at 1 site in Switzerland.
Trial summary
The study aims at assessing effectiveness of offering event-driven Doxy PEP and 4CMenB immunization in MSM/TGW at high STI risk. It plans to offer this STI prevention package to all MSM/TGW in the SHCS who are at risk of STI and then comparing 12-months STI incidence between those accepting and those not accepting the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Doxycycline STI PEP
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2023to 31 Oct 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population for this study are MSM or TGW at high risk for a bacterial STI (≥1 occasional partners within the preceding 6 months).
Who may be able to join
- ≥ 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)
Who cannot join
- Not participating in the SHCS
Trial locations and contacts
1 site in 1 country.
David Wimmersberger, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Dominique L Braun, MD, +41442559196, dominique.braun@usz.ch
David Wimmersberger, MD, david.wimmersberger@usz.ch
About this study
The study aims at assessing effectiveness of offering event-driven Doxy PEP and 4CMenB immunization in MSM/TGW at high STI risk. It plans to offer this STI prevention package to all MSM/TGW in the SHCS who are at risk of STI and then comparing 12-months STI incidence between those accepting and those not accepting the prevention package. The proposal further hosts two interesting sub-studies: One assessing potential effect of Doxy PEP on the microbiome and the other one assessing potential impact of Doxy PEP on TP, MG and CT resistance.
- Conditions
- Doxycycline STI PEP
- Keywords
- Docycycline, Postexposure Propylaxis, Bacterial sexaully tarnsmitted diseases, Sexuylly transmitted diseases, People living with HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People living with HIV participating in the Swiss HIV Cohort Study on doxycycline STI PEP | The target population for this study are MSM or TGW at high risk for a bacterial STI (≥1 occasional partners within the preceding 6 months) taking teh doxycycline STI PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of bacterial STIs
Overall incidence of bacterial STIs (including syphilis, CT, NG and MG)
Measured: From enrolment until the date of first event, assessed up to 96 weeks
Overall prevalence of bacterial STIs
Overall period prevalence of bacterial STIs (including syphilis, CT, NG and MG)
Measured: From enrolment to end of study, i.e. up to 96 weeks
STI incidence by individual infectious agent
STI incidence by individual infectious agent (syphilis, CT, NG; and MG if it is included in the local multiplex PCR panel)
Measured: From enrolment until the date of first event, assessed up to 96 weeks
STI period prevalence by individual infectious agent
STI period prevalence by individual infectious agent (syphilis, CT, NG; and MG if it is included in the local multiplex PCR panel)
Measured: From enrolment to end of study, i.e. up to 96 weeks
Secondary outcomes (4)
Acceptance of the intervention
Web-based online questionnaire on acceptance of the intervention implemented in the SHCS DJANGO tool assessed once for every participant during the whole study period
Measured: From enrolment assessed up to 96 weeks
Safety and adherence
Web-based online questionnaire on safety and adherence of the intervention implemented in the SHCS DJANGO tool, assessed at every SHCS visit (i.e. every six months)
Measured: From enrolment assessed up to 96 weeks
Genotypic resistance testing of STIs
Genotypic resistance testing for STIs either by whole genome sequencing or "SureSelect" approach performed at the time of detection of each STI
Measured: From enrolment assessed up to 96 weeks
Microbiome of the urethra and the rectum
Genotypic resistance testing for STIs either by whole genome sequencing or "SureSelect" approach performed at every SHCS visit (i.e. every six months)
Measured: From enrolment assessed up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Nov 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Doxycycline STI PEPStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss HIV Cohort Study
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242730
- Sponsor's protocol ID
- BASEC-Nr. 2023-01057
- Acronym
- DOXY-MEN
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06242730
- Acronym / sponsor ID
- DOXY-MEN / BASEC-Nr. 2023-01057
- Conditions
- Doxycycline STI PEP
- Keywords
- Docycycline, Postexposure Propylaxis, Bacterial sexaully tarnsmitted diseases, Sexuylly transmitted diseases, People living with HIV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss HIV Cohort Study
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims at assessing effectiveness of offering event-driven Doxy PEP and 4CMenB immunization in MSM/TGW at high STI risk. It plans to offer this STI prevention package to all MSM/TGW in the SHCS who are at risk of STI and then comparing 12-months STI incidence between those accepting and those not accepting the prevention package. The proposal further hosts two interesting sub-studies: One assessing potential effect of Doxy PEP on the microbiome and the other one assessing potential impact of Doxy PEP on TP, MG and CT resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People living with HIV participating in the Swiss HIV Cohort Study on doxycycline STI PEP | – | –The target population for this study are MSM or TGW at high risk for a bacterial STI (≥1 occasional partners within the preceding 6 months) taking teh doxycycline STI PEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study are MSM or TGW at high risk for a bacterial STI (≥1 occasional partners within the preceding 6 months).
Key inclusion criteria (8 listed)
- ≥ 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
Key exclusion criteria (1 listed)
- Not participating in the SHCS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall incidence of bacterial STIs
Time frame: From enrolment until the date of first event, assessed up to 96 weeks
Overall incidence of bacterial STIs (including syphilis, CT, NG and MG)
Overall prevalence of bacterial STIs
Time frame: From enrolment to end of study, i.e. up to 96 weeks
Overall period prevalence of bacterial STIs (including syphilis, CT, NG and MG)
STI incidence by individual infectious agent
Time frame: From enrolment until the date of first event, assessed up to 96 weeks
STI incidence by individual infectious agent (syphilis, CT, NG; and MG if it is included in the local multiplex PCR panel)
STI period prevalence by individual infectious agent
Time frame: From enrolment to end of study, i.e. up to 96 weeks
STI period prevalence by individual infectious agent (syphilis, CT, NG; and MG if it is included in the local multiplex PCR panel)
4 secondary outcomes
Acceptance of the intervention
Time frame: From enrolment assessed up to 96 weeks
Safety and adherence
Time frame: From enrolment assessed up to 96 weeks
Genotypic resistance testing of STIs
Time frame: From enrolment assessed up to 96 weeks
Microbiome of the urethra and the rectum
Time frame: From enrolment assessed up to 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Doxycycline STI PEP
RecruitingEarly Phase 1
Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP
Sexually Transmitted Diseases, Bacterial
Not yet recruitingPhase 3
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
HIV Infection, Sexually Transmitted Infection
Active, not recruitingPhase 4
Superiority of On-demand PrEP Versus PEP on Using Doxycycline for Preventing STI in MSM
Sexually Transmitted Diseases, Bacterial, Syphilis
RecruitingPhase 4
Got Doxy- 'Flipping the Script' on STI PEP
Sexually Transmitted Infections (STI)
Recruiting
Doxycycline Intervention for Bacterial STI ChemoprOphylaxis (DISCO)
Bacterial Sexually Transmitted Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wimmersberger, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Doxycycline STI PEP, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique L Braun, MD (0041442559196, dominique.braun@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of bacterial STIs (time frame: From enrolment until the date of first event, assessed up to 96 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.