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NCT Number: NCT03893188

The SwissPrEPared Study

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.

Recruiting

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Key information

Conditions

HIV Preexposure Prophylaxis

Age range

16 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonsspital Aarau, Aarau, Canton of Aargau, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of individuals asking for PrEP

    Time frame: 10 years

    Number of individuals asking for PrEP

  2. Proportion of individuals qualifying for PrEP according to current guidelines

    Time frame: 10 years

    Proportion of individuals qualifying for PrEP according to current guidelines

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

    Time frame: 10 years

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

  4. Mode of drug supply (pharmacy versus online)

    Time frame: 10 years

    Mode of drug supply (pharmacy versus online)

  5. Adherence rates to programme

    Time frame: 10 years

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

  6. Adherence rates to PrEP

    Time frame: 10 years

    Adherence rates to PrEP measured via self-report questionnaire

  7. Occurrence of side effects

    Time frame: 10 years

    Occurrence of side effects

  8. Prevalence of HIV

    Time frame: 10 years

    Prevalence of HIV

  9. Incidence of HIV

    Time frame: 10 years

    Incidence of HIV

  10. 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)

  11. 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 contacts

Contact information is provided by the study sponsor or research team.

Benjamin Hampel, MD

CONTACT

[email protected]

+41 44 634 46 11

Jan Fehr, Prof.

CONTACT

[email protected]

+41 44 634 46 11

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Cantonal Hospital of 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 of Bern
  • University of Lausanne Hospitals

Registry information

Official study 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'

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Mar 28, 2019
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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