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

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ClinicalTrials.gov Identifier: NCT03436407
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Anne Olaug Olsen, 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.


Condition or disease
Hiv Sexually Transmitted Diseases 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
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Implementation of Pre-exposure Prophylaxis (PrEP) in Subjects at Particular Risk of Infection With Human Immunodeficiency Virus (HIV).
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
PrEP Group
Subject offered to start PrEP treatment in routine clinical practice
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.



Primary Outcome Measures :
  1. Impact of PrEP [ Time Frame: 24 months ]
    Assess the impact of PrEP on the sexual and psychological health of PrEP users


Secondary Outcome Measures :
  1. Incidence of STIs [ Time Frame: 24 months ]
    Incidence of sexually transmitted infections (STIs) in PrEP users compared to those not taking PrEP

  2. Drug compliance [ Time Frame: 24 months ]
    Assessment of drug compliance

  3. HIV seroconversion [ Time Frame: 24 months ]
    Incidence of HIV seroconversion despite PrEP

  4. Drug resistance [ Time Frame: 24 months ]
    Frequency and development of drug resistance in subjects who HIV-seroconvert



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   transgender
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436407


Contacts
Contact: Jorge Johansen 23075840 ext 47 jorgej@ous-hf.no
Contact: Frank O Pettersen 22118080 ext 47 uxpfra@ous-hf.no

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

Documents provided by Anne Olaug Olsen, Oslo University Hospital:
Statistical Analysis Plan  [PDF] March 23, 2017
Study Protocol  [PDF] January 30, 2018
Informed Consent Form  [PDF] January 31, 2018


Responsible Party: Anne Olaug Olsen, Senior consultant/Assoc Prof, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03436407     History of Changes
Other Study ID Numbers: 2017/759
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female