The SwissPrEPared Study

Recruiting

• Conditions: HIV Preexposure Prophylaxis

• Registration Number: NCT03893188
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-28
• Study Start: 2019-04-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-06
• Primary Completion: 2030-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
Adherence rates to programme	10 years	Adherence rates to programme assessed via lost to follow-up and dropouts
Occurrence of side effects	10 years	Occurrence of side effects
Incidence of HIV	10 years	Incidence of HIV
Mode of drug supply (pharmacy versus online)	10 years	Mode of drug supply (pharmacy versus online)
Prevalence of HIV	10 years	Prevalence 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)
Adherence rates to PrEP	10 years	Adherence rates to PrEP measured via self-report questionnaire
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)

Trial Locations

Locations (41)

Kantonsspital Aarau; 🇨🇭 Aarau, Aargau, Switzerland

Kantonsspital Baden; 🇨🇭 Baden, Aargau, Switzerland

Praxis dr. med. Clara Thierfelder; 🇨🇭 Basel, Basel Stadt, Switzerland

MedCenter Volta; 🇨🇭 Basel, Basel-Stadt, Switzerland

Praxis Hammer; 🇨🇭 Basel, Basel-Stadt, Switzerland

University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland

Spitalzentrum Biel - Centre hospitalier Bienne; 🇨🇭 Biel, Bern, Switzerland

Spital Thun; 🇨🇭 Thun, Bern, Switzerland

Médecine Interne/Infectiologie FMH; 🇨🇭 Cottens, Fribourg, Switzerland

Kantonsspital Graubünden; 🇨🇭 Chur, Graubünden, Switzerland

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