HIV Preexposure ProphylaxisNCT03893188
The SwissPrEPared Study
An observational study of HIV Preexposure Prophylaxis, run by University of Zurich at 41 sites in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 16 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Preexposure Prophylaxis
- How many people
- 3,000 participants
- Where
- 41 sitesSwitzerland
- Study dates
- 10 Apr 2019to Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Participation in the SwissPrEPared program
- Aged ≥16 years
- HIV negative
Who cannot join
- Individuals unable to follow program procedures (e.g. language barriers, mental or psychiatric disorders)
Trial locations and contacts
41 sites in 1 country. Contact the study team or a site near you to ask about taking part.
41 sites in 1 country
Switzerland41 sites, 41 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Canton of Aargau, 5001
Anna Conen, MD, Anna.Conen@ksa.ch
- Recruiting
Kantonsspital Baden
Baden, Canton of Aargau, 5404
Andrée Friedl, MD, Andree.Friedl@ksb.ch
- Recruiting
MedCenter Volta
Basel, Canton of Basel-City, 4056
Madeleine Rothen, MD, m.rothen@hin.ch
- Recruiting
Praxis Hammer
Basel, Canton of Basel-City, 4057
Gerd Laifer, MD, gerd.laifer@praxishammer.ch
- Recruiting
Praxis dr. med. Clara Thierfelder
Basel, Canton of Basel-City, 4058
Clara Thierfelder, MD, clara.thierfelder@hin.ch
- Recruiting
University Hospital Basel
Basel, Canton of Basel-City
Marcel Stoeckle, Marcel.Stoeckle@usb.ch
- Recruiting
Checkpoint Bern
Bern, 3007
Bernard Surial, MD, Bernard.Surial@insel.ch
- Recruiting
University Hospital Bern
Bern, 3010
Bernard Surial, MD, Bernard.Surial@insel.ch
- Recruiting
Spitalzentrum Biel - Centre hospitalier Bienne
Biel/Bienne, Canton of Bern, 2501
Urs Fuehrer, MD, urs.fuehrer@szb-chb.ch
- Recruiting
Kantonsspital Graubünden
Chur, Kanton Graubünden, 7000
Franziska Marti, MD
- Recruiting
Médecine Interne/Infectiologie FMH
Cottens, Canton of Fribourg, 1741
Rémy Boscacci, MD, remy.boscacci@hin.ch
- Recruiting
Hôpital du Jura
Delémont, Canton of Jura, 2800
Tiago Castro, MD, Tiago.Castro@h-ju.ch
- Recruiting
Cabinet Dr. Marta Buzzi
Geneva, 1202
Marta Buzzi, MD, doc@marta-buzzi.ch
- Recruiting
Praxis Emmanuelle Boffi
Geneva, 1202
Emmanuelle Boffi, MD, e.boffi@cabinetmedical55.ch
- Recruiting
University Hospital Geneva
Geneva, 1205
Alexadnra Calmy, Prof, Alexandra.Calmy@hcuge.ch
- Recruiting
Cabinet Malagnou 2
Geneva, 1208
Oscar Montoro, MD, oscar.montoro@amge.ch
- Recruiting
Checkpoint Geneva
Geneva
Rafael Blanc, MD, rafael@dialogai.org
- Recruiting
Medical and Therapeutic Centre La Lignière
Gland, Canton of Vaud, 1196
Nicola Leggieri, MD, nicola.leggieri@svmed.ch
- Recruiting
Cabinet Dr. Erika Castro Batänjer
Lausanne, Canton of Vaud, 1003
Erika Castro Batänjer, MD, erika.castro@svmed.ch
- Recruiting
Cabinet Gare 10
Lausanne, Canton of Vaud, 1003
Loïc Lhopitallier, MD, loic.lhopitallier@gare10.ch
- Recruiting
Cabinet Rumine 35
Lausanne, Canton of Vaud, 1005
Christian Jaccard, MD, cjacc@bluewin.ch
- Recruiting
Cabinet Rumine 9
Lausanne, Canton of Vaud, 1005
Serge De Vallière, MD, serge.de-valliere@chuv.ch
- Recruiting
University Hospital Laussane
Lausanne, Canton of Vaud, 1005
Matthias Cavassini, Prof, Matthias.Cavassini@chuv.ch
- Recruiting
Checkpoint Lausanne
Lausanne, Canton of Vaud
Vanessa Christinet, MD, Vanessa.Christinet@profa.ch
- Recruiting
Maihofpraxis
Lucerne, 6004
Markus Herold, MD
- Recruiting
Kantonsspital Ticcino
Lugano, Ticcino
Enos Bernasconi, Prof, enos.bernasconi@eoc.ch
- Recruiting
Kantonsspital Münsterlingen
Münsterlingen, Thurgau, 8596
Sabine Majer, MD, sabine.majer@stgag.ch
- Recruiting
Réseau Hospitalier Neuchâtelois
Neuchâtel, 2000
Andrea Künzli, MD, andrea.kuenzli@rhne.ch
- Recruiting
Kantonsspital Olten
Olten, Canton of Solothurn, 4600
Matthias Hoffmann, MD, matthias.hoffmann@spital.so.ch
- Recruiting
Fondation PROFA
Renens VD, Canton of Vaud, 1020
Cate Esson, MD, Cate.Esson@profa.ch
- Recruiting
Kantonspital St. Gallen
Sankt Gallen, 9007
Notter Julia, MD, julia.notter@kssg.ch
- Recruiting
Spital Thun
Thun, Canton of Bern, 3600
Mirjam de Roche, MD, Mirjam.deRoche@spitalstsag.ch
- Recruiting
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8400
Kiyoshi Sugimoto, MD, kiyoshi.sugimoto@ksw.ch
- Recruiting
ARUD
Zurich, 8001
Claudia Bernardini, MD, C.Bernardini@arud.ch
- Not yet recruiting
Travel Clinic UZH
Zurich, 8001
Alexia Anagnostopoulos, MD, alexia.anagnostopoulos@uzh.ch
- Recruiting
Praxis Kalkbreite
Zurich, 8004
Carsten Depmeier, carsten.depmeier@arztpraxiskalkbreite.ch
- Recruiting
Checkpoint Zürich
Zurich, 8005
Benjamin Hampel, MD, +41 44 634 46 11, benjamin.hampel@checkpoint-zh.ch
Benjamin Hampel, MD
- Recruiting
Dermatologisches Zentrum Zürich AG
Zurich, 8006
Severin Läuchli, MD, laeuchli@dermazentrumzuerich.ch
- Recruiting
Praxisgemeinschaft D29
Zurich, 8008
Axel Marzeion, MD, axel.marzeion@hin.ch
- Recruiting
Stadtspital Triemli
Zurich, 8063
Leonardo Aceto, MD, Leonardo.Aceto@triemli.zuerich.ch
- Recruiting
Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich
Zurich, 8091
Dominique L Braun, MD, +41442559196, dominique.braun@usz.ch
About this study
Official title: 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.
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
- HIV Preexposure Prophylaxis
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 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of individuals asking for PrEP
Number of individuals asking for PrEP
Measured: 10 years
Proportion of individuals qualifying for PrEP according to current guidelines
Proportion of individuals qualifying for PrEP according to current guidelines
Measured: 10 years
PrEP regime used (daily, intermittent, on-demand)
PrEP regime used (daily, intermittent, on-demand)
Measured: 10 years
Mode of drug supply (pharmacy versus online)
Mode of drug supply (pharmacy versus online)
Measured: 10 years
Adherence rates to programme
Adherence rates to programme assessed via lost to follow-up and dropouts
Measured: 10 years
Adherence rates to PrEP
Adherence rates to PrEP measured via self-report questionnaire
Measured: 10 years
Occurrence of side effects
Occurrence of side effects
Measured: 10 years
Prevalence of HIV
Prevalence of HIV
Measured: 10 years
Incidence of HIV
Incidence of HIV
Measured: 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)
Measured: 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)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start10 Apr 2019
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV Preexposure ProphylaxisStudies of the same condition, open and under way.
- 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss HIV Cohort Study, Federal Office of Public Health, Switzerland, Positive Council Switzerland, Cantonal Hospital of St. Gallen, University of Bern, Cantonal Hospital, Baselland, University Hospital, Geneva, University of Lausanne Hospitals, University Hospital, Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Benjamin Hampel, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893188
- Sponsor's protocol ID
- BASEC-Nr.2018-02015
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2019
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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'
- ClinicalTrials.gov ID
- NCT03893188
- Acronym / sponsor ID
- BASEC-Nr.2018-02015
- Conditions
- HIV Preexposure Prophylaxis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss HIV Cohort Study, Federal Office of Public Health, Switzerland, Positive Council Switzerland, Cantonal Hospital of St. Gallen, University of Bern, Cantonal Hospital, Baselland, University Hospital, Geneva, University of Lausanne Hospitals, University Hospital, Basel, Switzerland
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 28 Mar 2019 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Participation in the SwissPrEPared program
- Aged ≥16 years
- HIV negative
Key exclusion criteria (1 listed)
- Individuals unable to follow program procedures (e.g. language barriers, mental or psychiatric disorders)
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
Number of individuals asking for PrEP
Time frame: 10 years
Number of individuals asking for PrEP
Proportion of individuals qualifying for PrEP according to current guidelines
Time frame: 10 years
Proportion of individuals qualifying for PrEP according to current guidelines
PrEP regime used (daily, intermittent, on-demand)
Time frame: 10 years
PrEP regime used (daily, intermittent, on-demand)
Mode of drug supply (pharmacy versus online)
Time frame: 10 years
Mode of drug supply (pharmacy versus online)
Adherence rates to programme
Time frame: 10 years
Adherence rates to programme assessed via lost to follow-up and dropouts
Adherence rates to PrEP
Time frame: 10 years
Adherence rates to PrEP measured via self-report questionnaire
Occurrence of side effects
Time frame: 10 years
Occurrence of side effects
Prevalence of HIV
Time frame: 10 years
Prevalence of HIV
Incidence of HIV
Time frame: 10 years
Incidence of HIV
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 34605153Hovaguimian 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.
- Individual participant dataSharing planned: 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.
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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.
Benjamin Hampel, MD principal investigator
University of Zurich
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Preexposure Prophylaxis, run by University of Zurich at 41 sites 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 3 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: looking for participants now, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Fehr, Prof. (+41 44 634 46 11, jan.fehr@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of individuals asking for PrEP (time frame: 10 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03893188, which also lists 1 linked publication.
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 6 Apr 2023.