The SwissPrEPared Study

April 3, 2023 updated by: University of Zurich

A Multicenter, Observational Cohort to Study the Characteristics of Individuals Asking for Pre-exposure Prophylaxis (PrEP) and the Incidence of HIV and Other Sexually Transmitted Infections: 'The SwissPrEPared Study'

Nested within the SwissPrEPared Program, the "SwissPrEPared Study" - a large, multicentric, nation-wide cohort study - aims to longitudinally follow individuals asking for PrEP prescription over a period of 3 years.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The main aims of the study will be:

  1. To obtain epidemiological data on individuals asking for PrEP in Switzerland. We are particularly interested in:

    • Determining the extent of PrEP use in Switzerland;
    • Assessing and monitoring the occurrence of sexually transmitted infections (STIs) in this particular population.
  2. To assess sexual health and sexual well-being in individuals asking for PrEP using a questionnaire specifically designed for the SwissPrEPared program.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

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

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
      • Bern, Switzerland, 3007
      • Geneva, Switzerland, 1205
        • Recruiting
        • University Hospital Geneva
      • Geneva, Switzerland, 1202
      • Geneva, Switzerland, 1202
      • Geneva, Switzerland, 1208
      • Geneva, Switzerland
      • Luzern, Switzerland, 6004
        • Recruiting
        • Maihofpraxis
        • Contact:
          • Markus Herold, MD
      • Neuchâtel, Switzerland, 2000
      • Saint Gallen, Switzerland, 9007
      • Zurich, Switzerland, 8091
        • Recruiting
        • Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich
        • Contact:
      • Zürich, Switzerland, 8063
      • Zürich, Switzerland, 8001
      • Zürich, Switzerland, 8001
      • Zürich, Switzerland, 8004
        • Recruiting
        • Praxis Kalkbreite
      • Zürich, Switzerland, 8005
        • Recruiting
        • Checkpoint Zürich
      • Zürich, Switzerland, 8006
      • Zürich, Switzerland, 8008
    • Aargau
      • Aarau, Aargau, Switzerland, 5001
      • Baden, Aargau, Switzerland, 5404
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4058
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4056
        • Recruiting
        • MedCenter Volta
        • Contact:
      • Basel, Basel-Stadt, Switzerland, 4057
      • Basel, Basel-Stadt, Switzerland
        • Recruiting
        • University Hospital Basel
    • Bern
      • Biel, Bern, Switzerland, 2501
        • Recruiting
        • Spitalzentrum Biel - Centre hospitalier Bienne
        • Contact:
      • Thun, Bern, Switzerland, 3600
    • Fribourg
      • Cottens, Fribourg, Switzerland, 1741
        • Recruiting
        • Médecine Interne/Infectiologie FMH
        • Contact:
    • Graubünden
      • Chur, Graubünden, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubünden
        • Contact:
          • Franziska Marti, MD
    • Jura
      • Delémont, Jura, Switzerland, 2800
    • Solothurn
    • Thurgau
      • Münsterlingen, Thurgau, Switzerland, 8596
    • Ticcino
      • Lugano, Ticcino, Switzerland
        • Recruiting
        • Kantonsspital Ticcino
    • Vaud
      • Gland, Vaud, Switzerland, 1196
      • Lausanne, Vaud, Switzerland, 1003
        • Recruiting
        • Cabinet Dr. Erika Castro Batänjer
        • Contact:
      • Lausanne, Vaud, Switzerland, 1003
      • Lausanne, Vaud, Switzerland, 1005
        • Recruiting
        • Cabinet Rumine 35
        • Contact:
      • Lausanne, Vaud, Switzerland, 1005
      • Renens VD, Vaud, Switzerland, 1020
    • Waadt
      • Lausanne, Waadt, Switzerland, 1005
        • Recruiting
        • University Hospital Laussane
      • Lausanne, Waadt, Switzerland
        • Recruiting
        • Checkpoint Lausanne
    • Zürich
      • Winterthur, Zürich, Switzerland, 8400

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

Ages Eligible for Study

16 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All individuals aged >16 years asking for PrEP prescription at one of the participating centers will be asked to participate to the SwissPrEPared study (consecutive ongoing recruitment). Only HIVnegative individuals will be deemed eligible. Participants for whom PrEP is not indicated or individuals declining PrEP will still be offered to participate in the study.

Description

Inclusion Criteria:

  • Participation in the SwissPrEPared program
  • Aged ≥16 years
  • HIV negative

Exclusion Criteria:

  • Individuals unable to follow program procedures (e.g. language barriers, mental or psychiatric disorders)

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
People asking for PrEP
All individuals aged >18 years asking for PrEP prescription at one of the participating centers will be asked to participate to the SwissPrEPared Study(consecutive ongoing recruitment). Only HIV negative individuals will be deemed eligible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of individuals asking for PrEP
Time Frame: 10 years
Number of individuals asking for PrEP
10 years
Proportion of individuals qualifying for PrEP according to current guidelines
Time Frame: 10 years
Proportion of individuals qualifying for PrEP according to current guidelines
10 years
PrEP regime used (daily, intermittent, on-demand)
Time Frame: 10 years
PrEP regime used (daily, intermittent, on-demand)
10 years
Mode of drug supply (pharmacy versus online)
Time Frame: 10 years
Mode of drug supply (pharmacy versus online)
10 years
Occurrence of side effects
Time Frame: 10 years
Occurrence of side effects
10 years
Adherence rates to programme
Time Frame: 10 years
Adherence rates to programme assessed via lost to follow-up and dropouts
10 years
Adherence rates to PrEP
Time Frame: 10 years
Adherence rates to PrEP measured via self-report questionnaire
10 years
Prevalence of HIV
Time Frame: 10 years
Prevalence of HIV
10 years
Incidence of HIV
Time Frame: 10 years
Incidence of HIV
10 years
Prevalence of other STIs (syphilis, hepatitis B, hepatitis C, gonorrhoea, chlamydia, mycoplasma genitalium)
Time Frame: 10 years
Prevalence of other STIs (syphilis, hepatitis B, hepatitis C, gonorrhoea, chlamydia, mycoplasma genitalium)
10 years
Incidence of other STIs (syphilis, hepatitis B, hepatitis C, gonorrhoea, chlamydia, mycoplasma genitalium)
Time Frame: 10 years
Incidence of other STIs (syphilis, hepatitis B, hepatitis C, gonorrhoea, chlamydia, mycoplasma genitalium)
10 years

Collaborators and Investigators

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

Sponsor

University of Zurich

Collaborators

University Hospital, Geneva
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
Federal Office of Public Health, Switzerland
Cantonal Hosptal, Baselland
Cantonal Hospital St. Gallen
Swiss HIV Cohort Study
Positive Council Switzerland
University Hospital, University of Bern

Investigators

  • Principal Investigator: Benjamin Hampel, MD, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 10, 2019

Primary Completion (Anticipated)

March 1, 2030

Study Completion (Anticipated)

March 1, 2030

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • BASEC-Nr.2018-02015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the study protocol (including the statistical plan) will be available after de-identification of participants following article publication. Data will be provided to investigators whose proposed use of the data has been approved by the study team and the Scientific Board of the Swiss HIV Cohort Study. Proposals should be directed to jan.fehr@usz.ch.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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