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 (DOXY-MEN)

February 1, 2024 updated by: University of Zurich
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
From enrolment until the date of first event, assessed up to 96 weeks
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)
From enrolment to end of study, i.e. up to 96 weeks
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)
From enrolment until the date of first event, assessed up to 96 weeks
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)
From enrolment to end of study, i.e. up to 96 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptance of the intervention
Time Frame: From enrolment assessed up to 96 weeks
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
From enrolment assessed up to 96 weeks
Safety and adherence
Time Frame: From enrolment assessed up to 96 weeks
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)
From enrolment assessed up to 96 weeks
Genotypic resistance testing of STIs
Time Frame: From enrolment assessed up to 96 weeks
Genotypic resistance testing for STIs either by whole genome sequencing or "SureSelect" approach performed at the time of detection of each STI
From enrolment assessed up to 96 weeks
Microbiome of the urethra and the rectum
Time Frame: From enrolment assessed up to 96 weeks
Genotypic resistance testing for STIs either by whole genome sequencing or "SureSelect" approach performed at every SHCS visit (i.e. every six months)
From enrolment assessed up to 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss HIV Cohort Study

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BASEC-Nr. 2023-01057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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