The SwissPrEPared Study

HIV Preexposure Prophylaxis Clinical Trial

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'

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03893188
• Other study ID #: BASEC-Nr.2018-02015
• Status: Recruiting
• Start date: April 10, 2019
• Est. completion date: March 2030

Study information

• Verified date: March 2023
• Source: University of Zurich
• Contact: Jan Fehr, Prof.
• Phone: +41 44 634 46 11
• Email: jan.fehr[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 2030
• Est. primary completion date: March 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• HIV Preexposure Prophylaxis

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau	Aargau
Switzerland	Kantonsspital Baden	Baden	Aargau
Switzerland	MedCenter Volta	Basel	Basel-Stadt
Switzerland	Praxis dr. med. Clara Thierfelder	Basel	Basel Stadt
Switzerland	Praxis Hammer	Basel	Basel-Stadt
Switzerland	University Hospital Basel	Basel	Basel-Stadt
Switzerland	Checkpoint Bern	Bern
Switzerland	University Hospital Bern	Bern
Switzerland	Spitalzentrum Biel - Centre hospitalier Bienne	Biel	Bern
Switzerland	Kantonsspital Graubünden	Chur	Graubünden
Switzerland	Médecine Interne/Infectiologie FMH	Cottens	Fribourg
Switzerland	Hôpital du Jura	Delémont	Jura
Switzerland	Cabinet Dr. Marta Buzzi	Geneva
Switzerland	Cabinet Malagnou 2	Geneva
Switzerland	Checkpoint Geneva	Geneva
Switzerland	Praxis Emmanuelle Boffi	Geneva
Switzerland	University Hospital Geneva	Geneva
Switzerland	Medical and Therapeutic Centre La Lignière	Gland	Vaud
Switzerland	Cabinet Dr. Erika Castro Batänjer	Lausanne	Vaud
Switzerland	Cabinet Gare 10	Lausanne	Vaud
Switzerland	Cabinet Rumine 35	Lausanne	Vaud
Switzerland	Cabinet Rumine 9	Lausanne	Vaud
Switzerland	Checkpoint Lausanne	Lausanne	Waadt
Switzerland	University Hospital Laussane	Lausanne	Waadt
Switzerland	Kantonsspital Ticcino	Lugano	Ticcino
Switzerland	Maihofpraxis	Luzern
Switzerland	Kantonsspital Münsterlingen	Münsterlingen	Thurgau
Switzerland	Réseau Hospitalier Neuchâtelois	Neuchâtel
Switzerland	Kantonsspital Olten	Olten	Solothurn
Switzerland	Fondation PROFA	Renens VD	Vaud
Switzerland	Kantonspital St. Gallen	Saint Gallen
Switzerland	Spital Thun	Thun	Bern
Switzerland	Kantonsspital Winterthur	Winterthur	Zürich
Switzerland	Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich	Zurich
Switzerland	ARUD	Zürich
Switzerland	Checkpoint Zürich	Zürich
Switzerland	Dermatologisches Zentrum Zürich AG	Zürich
Switzerland	Praxis Kalkbreite	Zürich
Switzerland	Praxisgemeinschaft D29	Zürich
Switzerland	Stadtspital Triemli	Zürich
Switzerland	Travel Clinic UZH	Zürich

Sponsors (10)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of individuals asking for PrEP	Number of individuals asking for PrEP	10 years
Primary	Proportion of individuals qualifying for PrEP according to current guidelines	Proportion of individuals qualifying for PrEP according to current guidelines	10 years
Primary	PrEP regime used (daily, intermittent, on-demand)	PrEP regime used (daily, intermittent, on-demand)	10 years
Primary	Mode of drug supply (pharmacy versus online)	Mode of drug supply (pharmacy versus online)	10 years
Primary	Adherence rates to programme	Adherence rates to programme assessed via lost to follow-up and dropouts	10 years
Primary	Adherence rates to PrEP	Adherence rates to PrEP measured via self-report questionnaire	10 years
Primary	Occurrence of side effects	Occurrence of side effects	10 years
Primary	Prevalence of HIV	Prevalence of HIV	10 years
Primary	Incidence of HIV	Incidence of HIV	10 years
Primary	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
Primary	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