The SwissPrEPared Study

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'

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03893188

Enrollment

3000

Registered

2019-03-28

Start date

2019-04-10

Completion date

2030-03-31

Last updated

2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Preexposure Prophylaxis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 120 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Countries

Switzerland

Contacts

Primary ContactJan Fehr, Prof.

jan.fehr@usz.ch+41 44 634 46 11

Backup ContactBenjamin Hampel, MD

hansbenjamin.hampel@usz.ch+41 44 634 46 11

Outcome results