NCT03436407

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).

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2017-10-25
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-02-19
• Last updated: 2018-02-19

Locations

9 sites across 1 country: Norway