Status:

UNKNOWN

Evaluation of Implementation of Pre-exposure Prophylaxis (PrEP) in Norway

Lead Sponsor:

Oslo University Hospital

Conditions:

Hiv

Sexually Transmitted Diseases

Eligibility:

All Genders

18+ years

Brief Summary

Despite the significant preventive efforts to reduce HIV infections in the past decades, the incidence in MSM has plateaued at a higher level after the turn of the millennium. In 2015 a reduction in n...

Detailed Description

This study is designed to evaluated implementation of PrEP treatment as a part of the general HIV preventive program in Norway. The target groups are mainly MSM and transgender persons at high risk of...

Eligibility Criteria

Inclusion

  • Male, female or transgender persons aged ≥ 18 years who are offered or have started PrEP in routine clinical practice, and 2, 3, 4, 5, 6 or 7 (below).
  • Men who have sex with men (MSM) and transgender persons;
  • who have had unprotected anal sex with two or more partners during the last six months and/or
  • who have had bacterial sexually transmittable infection(s) during the last twelve months and/or
  • who have used post-exposure prophylaxis(PEP) during the last twelve months and/or
  • who use recreational drugs when having sex
  • Indication for PrEP is present according to the assessment of the health care provider
  • Men and women who are at high risk of HIV according to their sexual practices
  • HIV-negative partner of a HIV-positive person not yet virologically suppressed by antiretroviral therapy (ART)
  • Sex workers with inconsistent condom use
  • Persons with inconsistent condom use with sexual partners in / from countries with a high prevalence of HIV (COHP)

Exclusion

  • HIV positive subjects
  • Subjects who cannot take Emtricitabine/tenofovir disoproxil combination tablet (FTC/TDF) due to contraindications

Key Trial Info

Start Date :

October 25 2017

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2020

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT03436407

Start Date

October 25 2017

End Date

December 31 2020

Last Update

February 19 2018

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Helse Bergen HF - Haukeland universitetssykehus

Bergen, Norway

2

Sørlandet sykehus HF

Kristiansand, Norway

3

Olafia Clinic,Oslo University Hosptial

Oslo, Norway, 0424

4

Akershus universitetssykehus HF

Oslo, Norway