The SwissPrEPared Study

Study Overview
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Brief Summary
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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
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The main aims of the study will be: 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. To assess sexual health and sexual well-being in individuals asking for PrEP using a questionnaire specifically designed for the SwissPrEPared program.

Official Title
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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'

Conditions
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HIV Preexposure Prophylaxis

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| People asking for PrEP<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |