RecruitingNCT03893188Updated Apr 6, 2023

The SwissPrEPared Study

An observational study in HIV Preexposure Prophylaxis, sponsored by University of Zurich. Recruiting at 41 sites in Switzerland. Open to participants aged 16 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-06.

Sponsored by University of Zurich · Observational

From the registry’s dates

Started Apr 2019; still recruiting 7 years 5 months later.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 3,000
Ages: 16 Years to 120 Years
Sex: All

Study summary

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.

Read the detailed description

The main aims of the study will be:

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.
To assess sexual health and sexual well-being in individuals asking for PrEP using a questionnaire specifically designed for the SwissPrEPared program.

Conditions studied

HIV Preexposure Prophylaxis

In context

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years to 120 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
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.

Inclusion criteria

Participation in the SwissPrEPared program
Aged ≥16 years
HIV negative

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 3,000 participants (estimated)
Patient registry: No

Groups and cohorts

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 researchers measure

Primary outcomes

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

Study locations

40 of 41 sites recruiting

Kantonsspital Aarau
Aarau, Aargau 5001, Switzerland
- Anna Conen, MD · Contact · Anna.Conen@ksa.ch
Recruiting
Kantonsspital Baden
Baden, Aargau 5404, Switzerland
- Andrée Friedl, MD · Contact · Andree.Friedl@ksb.ch
Recruiting
Praxis dr. med. Clara Thierfelder
Basel, Basel Stadt 4058, Switzerland
- Clara Thierfelder, MD · Contact · clara.thierfelder@hin.ch
Recruiting
MedCenter Volta
Basel, Basel-Stadt 4056, Switzerland
- Madeleine Rothen, MD · Contact · m.rothen@hin.ch
Recruiting
Praxis Hammer
Basel, Basel-Stadt 4057, Switzerland
- Gerd Laifer, MD · Contact · gerd.laifer@praxishammer.ch
Recruiting
University Hospital Basel
Basel, Basel-Stadt, Switzerland
- Marcel Stoeckle · Contact · Marcel.Stoeckle@usb.ch
Recruiting
Spitalzentrum Biel - Centre hospitalier Bienne
Biel, Bern 2501, Switzerland
- Urs Fuehrer, MD · Contact · urs.fuehrer@szb-chb.ch
Recruiting
Spital Thun
Thun, Bern 3600, Switzerland
- Mirjam de Roche, MD · Contact · Mirjam.deRoche@spitalstsag.ch
Recruiting
Médecine Interne/Infectiologie FMH
Cottens, Fribourg 1741, Switzerland
- Rémy Boscacci, MD · Contact · remy.boscacci@hin.ch
Recruiting
Kantonsspital Graubünden
Chur, Graubünden 7000, Switzerland
- Franziska Marti, MD · Contact
Recruiting
Hôpital du Jura
Delémont, Jura 2800, Switzerland
- Tiago Castro, MD · Contact · Tiago.Castro@h-ju.ch
Recruiting
Kantonsspital Olten
Olten, Solothurn 4600, Switzerland
- Matthias Hoffmann, MD · Contact · matthias.hoffmann@spital.so.ch
Recruiting
Kantonsspital Münsterlingen
Münsterlingen, Thurgau 8596, Switzerland
- Sabine Majer, MD · Contact · sabine.majer@stgag.ch
Recruiting
Kantonsspital Ticcino
Lugano, Ticcino, Switzerland
- Enos Bernasconi, Prof · Contact · enos.bernasconi@eoc.ch
Recruiting
Medical and Therapeutic Centre La Lignière
Gland, Vaud 1196, Switzerland
- Nicola Leggieri, MD · Contact · nicola.leggieri@svmed.ch
Recruiting
Cabinet Dr. Erika Castro Batänjer
Lausanne, Vaud 1003, Switzerland
- Erika Castro Batänjer, MD · Contact · erika.castro@svmed.ch
Recruiting
Cabinet Gare 10
Lausanne, Vaud 1003, Switzerland
- Loïc Lhopitallier, MD · Contact · loic.lhopitallier@gare10.ch
Recruiting
Cabinet Rumine 35
Lausanne, Vaud 1005, Switzerland
- Christian Jaccard, MD · Contact · cjacc@bluewin.ch
Recruiting
Cabinet Rumine 9
Lausanne, Vaud 1005, Switzerland
- Serge De Vallière, MD · Contact · serge.de-valliere@chuv.ch
Recruiting
Fondation PROFA
Renens VD, Vaud 1020, Switzerland
- Cate Esson, MD · Contact · Cate.Esson@profa.ch
Recruiting
University Hospital Laussane
Lausanne, Waadt 1005, Switzerland
- Matthias Cavassini, Prof · Contact · Matthias.Cavassini@chuv.ch
Recruiting
Checkpoint Lausanne
Lausanne, Waadt, Switzerland
- Vanessa Christinet, MD · Contact · Vanessa.Christinet@profa.ch
Recruiting
Kantonsspital Winterthur
Winterthur, Zürich 8400, Switzerland
- Kiyoshi Sugimoto, MD · Contact · kiyoshi.sugimoto@ksw.ch
Recruiting
Checkpoint Bern
Bern, 3007, Switzerland
- Bernard Surial, MD · Contact · Bernard.Surial@insel.ch
Recruiting
University Hospital Bern
Bern, 3010, Switzerland
- Bernard Surial, MD · Contact · Bernard.Surial@insel.ch
Recruiting
Cabinet Dr. Marta Buzzi
Geneva, 1202, Switzerland
- Marta Buzzi, MD · Contact · doc@marta-buzzi.ch
Recruiting
Praxis Emmanuelle Boffi
Geneva, 1202, Switzerland
- Emmanuelle Boffi, MD · Contact · e.boffi@cabinetmedical55.ch
Recruiting
University Hospital Geneva
Geneva, 1205, Switzerland
- Alexadnra Calmy, Prof · Contact · Alexandra.Calmy@hcuge.ch
Recruiting
Cabinet Malagnou 2
Geneva, 1208, Switzerland
- Oscar Montoro, MD · Contact · oscar.montoro@amge.ch
Recruiting
Checkpoint Geneva
Geneva, Switzerland
- Rafael Blanc, MD · Contact · rafael@dialogai.org
Recruiting
Maihofpraxis
Luzern, 6004, Switzerland
- Markus Herold, MD · Contact
Recruiting
Réseau Hospitalier Neuchâtelois
Neuchâtel, 2000, Switzerland
- Andrea Künzli, MD · Contact · andrea.kuenzli@rhne.ch
Recruiting
Kantonspital St. Gallen
Saint Gallen, 9007, Switzerland
- Notter Julia, MD · Contact · julia.notter@kssg.ch
Recruiting
Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich
Zurich, 8091, Switzerland
- Dominique L Braun, MD · Contact · dominique.braun@usz.ch · +41442559196
Recruiting
ARUD
Zürich, 8001, Switzerland
- Claudia Bernardini, MD · Contact · C.Bernardini@arud.ch
Recruiting
Travel Clinic UZH
Zürich, 8001, Switzerland
- Alexia Anagnostopoulos, MD · Contact · alexia.anagnostopoulos@uzh.ch
Not yet recruiting
Praxis Kalkbreite
Zürich, 8004, Switzerland
- Carsten Depmeier · Contact · carsten.depmeier@arztpraxiskalkbreite.ch
Recruiting
Checkpoint Zürich
Zürich, 8005, Switzerland
- Benjamin Hampel, MD · Contact · benjamin.hampel@checkpoint-zh.ch · +41 44 634 46 11
- Benjamin Hampel, MD · Principal investigator
Recruiting
Dermatologisches Zentrum Zürich AG
Zürich, 8006, Switzerland
- Severin Läuchli, MD · Contact · laeuchli@dermazentrumzuerich.ch
Recruiting
Praxisgemeinschaft D29
Zürich, 8008, Switzerland
- Axel Marzeion, MD · Contact · axel.marzeion@hin.ch
Recruiting
Stadtspital Triemli
Zürich, 8063, Switzerland
- Leonardo Aceto, MD · Contact · Leonardo.Aceto@triemli.zuerich.ch
Recruiting

References and documents

Publications

Hovaguimian F, Martin E, Reinacher M, Rasi M, Schmidt AJ, Bernasconi E, Boffi El Amari E, Braun DL, Calmy A, Darling K, Christinet V, Depmeier C, Hauser C, Lauchli S, Notter J, Stoeckle M, Surial B, Vernazza P, Bruggmann P, Tarr P, Haerry D, Bize R, Low N, Lehner A, Boni J, Kouyos RD, Fehr JS, Hampel B. Participation, retention and uptake in a multicentre pre-exposure prophylaxis cohort using online, smartphone-compatible data collection. HIV Med. 2022 Feb;23(2):146-158. doi: 10.1111/hiv.13175. Epub 2021 Oct 3. PubMed 34605153 ↗

Study documents

Protocol and statistical analysis plan · Feb 26, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03893188
Lead sponsor: University of Zurich
Collaborators: Swiss HIV Cohort Study, Federal Office of Public Health, Switzerland, Positive Council Switzerland, Cantonal Hospital St. Gallen, University Hospital, University of Bern, Cantonal Hosptal, Baselland, University Hospital, Geneva, University of Lausanne Hospitals, University Hospital, Basel, Switzerland
Responsible party: Sponsor
First posted: Mar 28, 2019
Start date: Apr 10, 2019
Primary completion: Mar 2030 (estimated)
Completion: Mar 2030 (estimated)
Last update: Apr 6, 2023

Study contacts

Jan Fehr, Prof.

Contact

jan.fehr@usz.ch

+41 44 634 46 11

Benjamin Hampel, MD

Contact

hansbenjamin.hampel@usz.ch

+41 44 634 46 11

Benjamin Hampel, MD

principal investigator · University of Zurich

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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