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

NCT ID: NCT03436407

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2020-12-31

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 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.

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)

Conditions

Hiv; Sexually Transmitted Diseases; Mental Health Wellness 1

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

PrEP Group

Subject offered to start PrEP treatment in routine clinical practice

No interventions assigned to this group

Control Group

1. 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.

2. 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)

3. Frequency of STI reported to the National Institute of Public Health (MSIS) will be compared with the frequency of STIs in the study cohort.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Olaug Olsen

Senior consultant/Assoc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Olaug Olsen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Helse Bergen HF - Haukeland universitetssykehus

Bergen, , Norway

Site Status: NOT_YET_RECRUITING

Sørlandet sykehus HF

Kristiansand, , Norway

Site Status: NOT_YET_RECRUITING

Olafia Clinic,Oslo University Hosptial

Oslo, , Norway

Site Status: RECRUITING

Akershus universitetssykehus HF

Oslo, , Norway

Site Status: RECRUITING

Brynsenglegene

Oslo, , Norway

Site Status: NOT_YET_RECRUITING

Dept. Inf. Diseases, Oslo University Hospital

Oslo, , Norway

Site Status: NOT_YET_RECRUITING

Helse Stavanger HF - Stavanger universitetssjukehus

Stavanger, , Norway

Site Status: RECRUITING

Universitetssykehuset Nord-Norge HF

Tromsø, , Norway

Site Status: NOT_YET_RECRUITING

Helse Midt-Norge St Olavs Hospital

Trondheim, , Norway

Site Status: NOT_YET_RECRUITING

Countries

Norway

Central Contacts

Jorge Johansen

Role: CONTACT

jorgej@ous-hf.no

23075840 ext. 47

Frank O Pettersen

Role: CONTACT

uxpfra@ous-hf.no

22118080 ext. 47

Facility Contacts

Rafael Alexander Leiva, MD PhD

Role: primary

rafael.alexander.modahl.leiva@helse-bergen.no

55 97 50 00 ext. 47

Turid Jorunn Thune, MD

Role: backup

turid.jorunn.thune@helse-bergen.no

55 97 50 00 ext. 47

Ole Rysstad, MD

Role: primary

ole.rysstad@sshf.no

03738 ext. 47

Jorge Johansen, nurse

Role: primary

jorgej@ous-hf.no

23075840 ext. 47

Michelle Hanlon, MD

Role: backup

mihanl@ous-hf.no

23075840 ext. 47

Eirik Pettersen, MD

Role: primary

Eirik.Pettersen@ahus.no

67960000 ext. 47

Thomas Tønseth, MD

Role: primary

thomas.tonseth@brynsenglegene.no

22727850 ext. 47

Frank Pettersen, MD PhD

Role: primary

uxpfra@ous-hf.no

91502770 ext. 47

Linda Skeie

Role: backup

LISKEI@ous-hf.no

91502770

Sonali R Hansen, MD

Role: primary

sonali.rathour.hansen@sus.no

51518000 ext. 47

Vegard Skogen, MD PhD

Role: primary

Vegard.Skogen@unn.no

77626000 ext. 47

Kristin Ryggen, MD

Role: primary

kristin.ryggen@stolav.no

815 55 850 ext. 47

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017/759

Identifier Type: -

Identifier Source: org_study_id