NCT03893188

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

41 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Apr 2019Mar 2030

First Submitted

Initial submission to the registry

March 14, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

10.9 years

First QC Date

March 14, 2019

Last Update Submit

April 3, 2023

Conditions

Outcome Measures

Primary Outcomes (11)

  • Number of individuals asking for PrEP

    Number of individuals asking for PrEP

    10 years

  • Proportion of individuals qualifying for PrEP according to current guidelines

    Proportion of individuals qualifying for PrEP according to current guidelines

    10 years

  • PrEP regime used (daily, intermittent, on-demand)

    PrEP regime used (daily, intermittent, on-demand)

    10 years

  • Mode of drug supply (pharmacy versus online)

    Mode of drug supply (pharmacy versus online)

    10 years

  • Adherence rates to programme

    Adherence rates to programme assessed via lost to follow-up and dropouts

    10 years

  • Adherence rates to PrEP

    Adherence rates to PrEP measured via self-report questionnaire

    10 years

  • Occurrence of side effects

    Occurrence of side effects

    10 years

  • Prevalence of HIV

    Prevalence of HIV

    10 years

  • Incidence of HIV

    Incidence of HIV

    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)

    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)

    10 years

Study Arms (1)

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.

Eligibility Criteria

Age16 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

RECRUITING

MedCenter Volta

Basel, Canton of Basel-City, 4056, Switzerland

RECRUITING

Praxis Hammer

Basel, Canton of Basel-City, 4057, Switzerland

RECRUITING

Praxis dr. med. Clara Thierfelder

Basel, Canton of Basel-City, 4058, Switzerland

RECRUITING

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

RECRUITING

Spitalzentrum Biel - Centre hospitalier Bienne

Biel/Bienne, Canton of Bern, 2501, Switzerland

RECRUITING

Spital Thun

Thun, Canton of Bern, 3600, Switzerland

RECRUITING

Médecine Interne/Infectiologie FMH

Cottens, Canton of Fribourg, 1741, Switzerland

RECRUITING

Hôpital du Jura

Delémont, Canton of Jura, 2800, Switzerland

RECRUITING

Kantonsspital Olten

Olten, Canton of Solothurn, 4600, Switzerland

RECRUITING

Medical and Therapeutic Centre La Lignière

Gland, Canton of Vaud, 1196, Switzerland

RECRUITING

Cabinet Dr. Erika Castro Batänjer

Lausanne, Canton of Vaud, 1003, Switzerland

RECRUITING

Cabinet Gare 10

Lausanne, Canton of Vaud, 1003, Switzerland

RECRUITING

Cabinet Rumine 35

Lausanne, Canton of Vaud, 1005, Switzerland

RECRUITING

Cabinet Rumine 9

Lausanne, Canton of Vaud, 1005, Switzerland

RECRUITING

University Hospital Laussane

Lausanne, Canton of Vaud, 1005, Switzerland

RECRUITING

Checkpoint Lausanne

Lausanne, Canton of Vaud, Switzerland

RECRUITING

Fondation PROFA

Renens VD, Canton of Vaud, 1020, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

RECRUITING

Kantonsspital Graubünden

Chur, Kanton Graubünden, 7000, Switzerland

RECRUITING

Kantonsspital Münsterlingen

Münsterlingen, Thurgau, 8596, Switzerland

RECRUITING

Kantonsspital Ticcino

Lugano, Ticcino, Switzerland

RECRUITING

Checkpoint Bern

Bern, 3007, Switzerland

RECRUITING

University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

Cabinet Dr. Marta Buzzi

Geneva, 1202, Switzerland

RECRUITING

Praxis Emmanuelle Boffi

Geneva, 1202, Switzerland

RECRUITING

University Hospital Geneva

Geneva, 1205, Switzerland

RECRUITING

Cabinet Malagnou 2

Geneva, 1208, Switzerland

RECRUITING

Checkpoint Geneva

Geneva, Switzerland

RECRUITING

Maihofpraxis

Lucerne, 6004, Switzerland

RECRUITING

Réseau Hospitalier Neuchâtelois

Neuchâtel, 2000, Switzerland

RECRUITING

Kantonspital St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

ARUD

Zurich, 8001, Switzerland

RECRUITING

Travel Clinic UZH

Zurich, 8001, Switzerland

NOT YET RECRUITING

Praxis Kalkbreite

Zurich, 8004, Switzerland

RECRUITING

Checkpoint Zürich

Zurich, 8005, Switzerland

RECRUITING

Dermatologisches Zentrum Zürich AG

Zurich, 8006, Switzerland

RECRUITING

Praxisgemeinschaft D29

Zurich, 8008, Switzerland

RECRUITING

Stadtspital Triemli

Zurich, 8063, Switzerland

RECRUITING

Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich

Zurich, 8091, Switzerland

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Benjamin Hampel, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 28, 2019

Study Start

April 10, 2019

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Last Updated

April 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP

Locations