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Clinical Trials/NCT03893188
NCT03893188
Recruiting
Not Applicable

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'

University of Zurich41 sites in 1 country3,000 target enrollmentApril 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Preexposure Prophylaxis
Sponsor
University of Zurich
Enrollment
3000
Locations
41
Primary Endpoint
Number of individuals asking for PrEP
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 10, 2019
End Date
March 2030
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Number of individuals asking for PrEP

Time Frame: 10 years

Number of individuals asking for PrEP

Proportion of individuals qualifying for PrEP according to current guidelines

Time Frame: 10 years

Proportion of individuals qualifying for PrEP according to current guidelines

PrEP regime used (daily, intermittent, on-demand)

Time Frame: 10 years

PrEP regime used (daily, intermittent, on-demand)

Adherence rates to programme

Time Frame: 10 years

Adherence rates to programme assessed via lost to follow-up and dropouts

Occurrence of side effects

Time Frame: 10 years

Occurrence of side effects

Incidence of HIV

Time Frame: 10 years

Incidence of HIV

Mode of drug supply (pharmacy versus online)

Time Frame: 10 years

Mode of drug supply (pharmacy versus online)

Prevalence of HIV

Time Frame: 10 years

Prevalence of HIV

Prevalence of other STIs (syphilis, hepatitis B, hepatitis C, gonorrhoea, chlamydia, mycoplasma genitalium)

Time Frame: 10 years

Prevalence of other STIs (syphilis, hepatitis B, hepatitis C, gonorrhoea, chlamydia, mycoplasma genitalium)

Adherence rates to PrEP

Time Frame: 10 years

Adherence rates to PrEP measured via self-report questionnaire

Incidence of other STIs (syphilis, hepatitis B, hepatitis C, gonorrhoea, chlamydia, mycoplasma genitalium)

Time Frame: 10 years

Incidence of other STIs (syphilis, hepatitis B, hepatitis C, gonorrhoea, chlamydia, mycoplasma genitalium)

Study Sites (41)

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