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

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

• Registration Number: NCT03436407
• Lead Sponsor: Oslo University Hospital

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)

Study Timeline

• Study Start: 2017-10-25
• Status Verified: 2018-02
• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-12
• Last Update Submitted: 2018-02-12
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-19
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of PrEP	24 months	Assess the impact of PrEP on the sexual and psychological health of PrEP users

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Helse Bergen HF - Haukeland universitetssykehus; 🇳🇴 Bergen, Norway

Olafia Clinic,Oslo University Hosptial; 🇳🇴 Oslo, Norway

Brynsenglegene; 🇳🇴 Oslo, Norway

Helse Stavanger HF - Stavanger universitetssjukehus; 🇳🇴 Stavanger, Norway

Universitetssykehuset Nord-Norge HF; 🇳🇴 Tromsø, Norway

Helse Midt-Norge St Olavs Hospital; 🇳🇴 Trondheim, Norway

Sørlandet sykehus HF; 🇳🇴 Kristiansand, Norway

Akershus universitetssykehus HF; 🇳🇴 Oslo, Norway

Dept. Inf. Diseases, Oslo University Hospital; 🇳🇴 Oslo, Norway