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

Evaluation of Implementation of Pre-exposure Prophylaxis (PrEP) in Subjects at Particular Risk of Infection With Human Immunodeficiency Virus (HIV).

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 newly diagnosed HIV cases was reported for the first time. Early detection of HIV and treatment as prevention may have played a positive role in reducing HIV transmission, however, numbers increased again in 2016. Over 90% of HIV positive MSM in Norway are treated and virologically suppressed and thereby considered not infectious.

Since the early days of the HIV epidemic, changes in sexual behaviour and increased use of condoms have been advocated and the only tools available to prevent HIV transmission. Later, frequent testing and treatment of STIs (including HIV) have been added to the preventive measures available. Still, this does not seem to be sufficient for all MSM. The use of PrEP is therefore likely an important supplement to prevent HIV infections in MSM at high risk for HIV acquisition.

The main objective of this study is to monitor the impact of PrEP on the subject's psychological and sexual health. It is also important to monitor the adherence to PrEP, development of drug resistance (in the case of undetected HIV infection at initiation of PrEP), frequency of other STIs, changes in sexual behaviour, recreational drug use and quality of life. PrEP has proven to be effective in reducing the sexual acquisition of HIV, however this requires that the medication is taken as prescribed, whilst the subject is exposed to high risk of infection.

Study Overview

• Status: Unknown
• Conditions: Sexually Transmitted Diseases; Hiv; Mental Health Wellness 1

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 HIV infection, as well as other subjects at risk of HIV infection due to their sexual practices.

Objectives include assessment of the following:

1. Assess the impact of PrEP on the sexual and psychological health of PrEP users Incidence of sexually transmitted infections (STIs) in PrEP users compared to those not taking PrEP
2. Assessment of drug compliance
3. Incidence of HIV seroconversion despite PrEP
4. Frequency and development of drug resistance in subjects who HIV-seroconvert (if any)

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Jorge Johansen; Phone Number: 47 23075840; Email: jorgej@ous-hf.no
• Study Contact Backup: Name: Frank O Pettersen; Phone Number: 47 22118080; Email: uxpfra@ous-hf.no

Study Locations

• Norway
  • Bergen, Norway
    • Not yet recruiting
    • Helse Bergen HF - Haukeland universitetssykehus
    • Contact: Rafael Alexander Leiva, MD PhD; Phone Number: 47 55 97 50 00; Email: rafael.alexander.modahl.leiva@helse-bergen.no
    • Contact: Turid Jorunn Thune, MD; Phone Number: 47 55 97 50 00; Email: turid.jorunn.thune@helse-bergen.no
    • Sub-Investigator: Turid Jorunn Thune, MD
    • Sub-Investigator: Rafael Alexander Leiva, MD
  • Kristiansand, Norway
    • Not yet recruiting
    • Sørlandet Sykehus HF
    • Contact: Ole Rysstad, MD; Phone Number: 47 03738; Email: ole.rysstad@sshf.no
  • Oslo, Norway, 0424
    • Recruiting
    • Olafia Clinic,Oslo University Hosptial
    • Contact: Jorge Johansen, nurse; Phone Number: 47 23075840; Email: jorgej@ous-hf.no
    • Contact: Michelle Hanlon, MD; Phone Number: 47 23075840; Email: mihanl@ous-hf.no
    • Principal Investigator: Anne Olaug Olsen, MD PhD
    • Sub-Investigator: Michelle Hanlon, MD
    • Sub-Investigator: Frank O Pettersen, MD PhD
  • Oslo, Norway
    • Recruiting
    • Akershus Universitetssykehus HF
    • Contact: Eirik Pettersen, MD; Phone Number: 47 67960000; Email: Eirik.Pettersen@ahus.no
  • Oslo, Norway
    • Not yet recruiting
    • Brynsenglegene
    • Contact: Thomas Tønseth, MD; Phone Number: 47 22727850; Email: thomas.tonseth@brynsenglegene.no
  • Oslo, Norway
    • Not yet recruiting
    • Dept. Inf. Diseases, Oslo University Hospital
    • Contact: Frank Pettersen, MD PhD; Phone Number: 47 91502770; Email: uxpfra@ous-hf.no
    • Contact: Linda Skeie; Phone Number: 91502770; Email: LISKEI@ous-hf.no
  • Stavanger, Norway
    • Recruiting
    • Helse Stavanger HF - Stavanger universitetssjukehus
    • Contact: Sonali R Hansen, MD; Phone Number: 47 51518000; Email: sonali.rathour.hansen@sus.no
  • Tromsø, Norway
    • Not yet recruiting
    • Universitetssykehuset Nord-Norge HF
    • Contact: Vegard Skogen, MD PhD; Phone Number: 47 77626000; Email: Vegard.Skogen@unn.no
  • Trondheim, Norway
    • Not yet recruiting
    • Helse Midt-Norge St Olavs Hospital
    • Contact: Kristin Ryggen, MD; Phone Number: 47 815 55 850; Email: kristin.ryggen@stolav.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals attending the clinic for PrEP assessment are either referred from other health care providers or referred by themselves (self-referral).

Those who have commenced PrEP elsewhere (abroad, purchased themselves, another provider) and attend for "PrEP follow-up" either at Olafiaklinikken or a corresponding venerological clinic/study site in Norway, may also be included in the study.

Newly diagnosed HIV positive individuals referred to the out-patient clinic of the Dept. of Infectious Diseases, OUS, will be invited to participate as controls. They will be presented with the same consent form and questionnaire on sexual and psychological health prior to the HIV diagnosis.

Description

Inclusion Criteria:

1. 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).

2. Men who have sex with men (MSM) and transgender persons;

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PrEP Group; Subject offered to start PrEP treatment in routine clinical practice
Control Group; Enrolled patients will be regarded as their own control when it comes to their sexual health and quality of life reported for period prior to inclusion in the study.; Subjects diagnosed with HIV within last 12 months in general clinical practice and referred to the outpatient clinic at the Dept. of Infectious Diseases, OUS. (details in protocol 3.3.2); Frequency of STI reported to the National Institute of Public Health (MSIS) will be compared with the frequency of STIs in the study cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of PrEP	Assess the impact of PrEP on the sexual and psychological health of PrEP users	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of STIs	Incidence of sexually transmitted infections (STIs) in PrEP users compared to those not taking PrEP	24 months
Drug compliance	Assessment of drug compliance	24 months
HIV seroconversion	Incidence of HIV seroconversion despite PrEP	24 months
Drug resistance	Frequency and development of drug resistance in subjects who HIV-seroconvert	24 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Anne Olaug Olsen, MD PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: 2017/759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO