Clinical trial NCT03893188: The SwissPrEPared 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'
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Preexposure Prophylaxis
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss HIV Cohort Study
name: Federal Office of Public Health, Switzerland
name: Positive Council Switzerland
name: Cantonal Hospital St. Gallen
name: University Hospital, University of Bern
name: Cantonal Hosptal, Baselland
name: University Hospital, Geneva
name: University of Lausanne Hospitals
name: University Hospital, Basel, Switzerland
First posted: 2019-03-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of individuals asking for PrEP
timeFrame: 10 years
measure: Proportion of individuals qualifying for PrEP according to current guidelines
timeFrame: 10 years
measure: PrEP regime used (daily, intermittent, on-demand)
timeFrame: 10 years
measure: Mode of drug supply (pharmacy versus online)
timeFrame: 10 years
measure: Adherence rates to programme
timeFrame: 10 years
measure: Adherence rates to PrEP
timeFrame: 10 years
measure: Occurrence of side effects
timeFrame: 10 years
measure: Prevalence of HIV
timeFrame: 10 years
measure: Incidence of HIV
timeFrame: 10 years
measure: Prevalence of other STIs (syphilis, hepatitis B, hepatitis C, gonorrhoea, chlamydia, mycoplasma genitalium)
timeFrame: 10 years
measure: Incidence of other STIs (syphilis, hepatitis B, hepatitis C, gonorrhoea, chlamydia, mycoplasma genitalium)
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
state: Aargau
city: Baden
country: Switzerland
facility: Kantonsspital Baden
state: Aargau
city: Basel
country: Switzerland
facility: Praxis dr. med. Clara Thierfelder
state: Basel Stadt
city: Basel
country: Switzerland
facility: MedCenter Volta
state: Basel-Stadt
city: Basel
country: Switzerland
facility: Praxis Hammer
state: Basel-Stadt
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
city: Biel
country: Switzerland
facility: Spitalzentrum Biel - Centre hospitalier Bienne
state: Bern
city: Thun
country: Switzerland
facility: Spital Thun
state: Bern
city: Cottens
country: Switzerland
facility: Médecine Interne/Infectiologie FMH
state: Fribourg
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
state: Graubünden
city: Delémont
country: Switzerland
facility: Hôpital du Jura
state: Jura
city: Olten
country: Switzerland
facility: Kantonsspital Olten
state: Solothurn
city: Münsterlingen
country: Switzerland
facility: Kantonsspital Münsterlingen
state: Thurgau
city: Lugano
country: Switzerland
facility: Kantonsspital Ticcino
state: Ticcino
city: Gland
country: Switzerland
facility: Medical and Therapeutic Centre La Lignière
state: Vaud
city: Lausanne
country: Switzerland
facility: Cabinet Dr. Erika Castro Batänjer
state: Vaud
city: Lausanne
country: Switzerland
facility: Cabinet Gare 10
state: Vaud
city: Lausanne
country: Switzerland
facility: Cabinet Rumine 35
state: Vaud
city: Lausanne
country: Switzerland
facility: Cabinet Rumine 9
state: Vaud
city: Renens VD
country: Switzerland
facility: Fondation PROFA
state: Vaud
city: Lausanne
country: Switzerland
facility: University Hospital Laussane
state: Waadt
city: Lausanne
country: Switzerland
facility: Checkpoint Lausanne
state: Waadt
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zürich
city: Bern
country: Switzerland
facility: Checkpoint Bern
city: Bern
country: Switzerland
facility: University Hospital Bern
city: Geneva
country: Switzerland
facility: Cabinet Dr. Marta Buzzi
city: Geneva
country: Switzerland
facility: Praxis Emmanuelle Boffi
city: Geneva
country: Switzerland
facility: University Hospital Geneva
city: Geneva
country: Switzerland
facility: Cabinet Malagnou 2
city: Geneva
country: Switzerland
facility: Checkpoint Geneva
city: Luzern
country: Switzerland
facility: Maihofpraxis
city: Neuchâtel
country: Switzerland
facility: Réseau Hospitalier Neuchâtelois
city: Saint Gallen
country: Switzerland
facility: Kantonspital St. Gallen
city: Zurich
country: Switzerland
facility: Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich
city: Zürich
country: Switzerland
facility: ARUD
city: Zürich
country: Switzerland
facility: Travel Clinic UZH
city: Zürich
country: Switzerland
facility: Praxis Kalkbreite
city: Zürich
country: Switzerland
facility: Checkpoint Zürich
city: Zürich
country: Switzerland
facility: Dermatologisches Zentrum Zürich AG
city: Zürich
country: Switzerland
facility: Praxisgemeinschaft D29
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: University of Zurich
name: Benjamin Hampel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.