HivNCT03436407
Evaluation of Implementation of Pre-exposure Prophylaxis (PrEP) in Norway
An observational study of Hiv and Sexually Transmitted Diseases, run by Oslo University Hospital at 9 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Sexually Transmitted Diseases, Mental Health Wellness 1
- How many people
- 500 participants
- Where
- 9 sitesNorway
- Study dates
- 25 Oct 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
- Men who have sex with men (MSM) and transgender persons;
- who have had unprotected anal sex with two or more partners during the last six months and/or
- who have had bacterial sexually transmittable infection(s) during the last twelve months and/or
- who have used post-exposure prophylaxis(PEP) during the last twelve months and/or
- who use recreational drugs when having sex
Show all 11Show fewer
- Indication for PrEP is present according to the assessment of the health care provider
- Men and women who are at high risk of HIV according to their sexual practices
- HIV-negative partner of a HIV-positive person not yet virologically suppressed by antiretroviral therapy (ART)
- Sex workers with inconsistent condom use
- Persons with inconsistent condom use with sexual partners in / from countries with a high prevalence of HIV (COHP)
Who cannot join
- HIV positive subjects
- Subjects who cannot take Emtricitabine/tenofovir disoproxil combination tablet (FTC/TDF) due to contraindications
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Norway9 sites, 9 recruiting
- Not yet recruiting
Helse Bergen HF - Haukeland universitetssykehus
Bergen
Rafael Alexander Leiva, MD PhD, 55 97 50 00 ext. 47, rafael.alexander.modahl.leiva@helse-bergen.no
Turid Jorunn Thune, MD, 55 97 50 00 ext. 47, turid.jorunn.thune@helse-bergen.no
- Not yet recruiting
Sørlandet sykehus HF
Kristiansand
Ole Rysstad, MD, 03738 ext. 47, ole.rysstad@sshf.no
- Recruiting
Olafia Clinic,Oslo University Hosptial
Oslo, 0424
Jorge Johansen, nurse, 23075840 ext. 47, jorgej@ous-hf.no
Michelle Hanlon, MD, 23075840 ext. 47, mihanl@ous-hf.no
- Recruiting
Akershus universitetssykehus HF
Oslo
Eirik Pettersen, MD, 67960000 ext. 47, Eirik.Pettersen@ahus.no
- Not yet recruiting
Brynsenglegene
Oslo
Thomas Tønseth, MD, 22727850 ext. 47, thomas.tonseth@brynsenglegene.no
- Not yet recruiting
Dept. Inf. Diseases, Oslo University Hospital
Oslo
Frank Pettersen, MD PhD, 91502770 ext. 47, uxpfra@ous-hf.no
Linda Skeie, 91502770, LISKEI@ous-hf.no
- Recruiting
Helse Stavanger HF - Stavanger universitetssjukehus
Stavanger
Sonali R Hansen, MD, 51518000 ext. 47, sonali.rathour.hansen@sus.no
- Not yet recruiting
Universitetssykehuset Nord-Norge HF
Tromsø
Vegard Skogen, MD PhD, 77626000 ext. 47, Vegard.Skogen@unn.no
- Not yet recruiting
Helse Midt-Norge St Olavs Hospital
Trondheim
Kristin Ryggen, MD, 815 55 850 ext. 47, kristin.ryggen@stolav.no
About this study
Official title: 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.
Read the 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:
- 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
- Assessment of drug compliance
- Incidence of HIV seroconversion despite PrEP
- Frequency and development of drug resistance in subjects who HIV-seroconvert (if any)
- Conditions
- Hiv, Sexually Transmitted Diseases, Mental Health Wellness 1
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of PrEP
Assess the impact of PrEP on the sexual and psychological health of PrEP users
Measured: 24 months
Secondary outcomes (4)
Incidence of STIs
Incidence of sexually transmitted infections (STIs) in PrEP users compared to those not taking PrEP
Measured: 24 months
Drug compliance
Assessment of drug compliance
Measured: 24 months
HIV seroconversion
Incidence of HIV seroconversion despite PrEP
Measured: 24 months
Drug resistance
Frequency and development of drug resistance in subjects who HIV-seroconvert
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start25 Oct 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Olaug Olsen, Oslo University Hospital
- Investigators
- Anne Olaug Olsen, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436407
- Sponsor's protocol ID
- 2017/759
- Status last verified
- Feb 2018
- First submitted
- 12 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implementation of Pre-exposure Prophylaxis (PrEP) in Subjects at Particular Risk of Infection With Human Immunodeficiency Virus (HIV).
- ClinicalTrials.gov ID
- NCT03436407
- Acronym / sponsor ID
- 2017/759
- Conditions
- Hiv, Sexually Transmitted Diseases, Mental Health Wellness 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Assessment of drug compliance
- Incidence of HIV seroconversion despite PrEP
- Frequency and development of drug resistance in subjects who HIV-seroconvert (if any)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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).
- Men who have sex with men (MSM) and transgender persons;
- Indication for PrEP is present according to the assessment of the health care provider
- Men and women who are at high risk of HIV according to their sexual practices
- HIV-negative partner of a HIV-positive person not yet virologically suppressed by antiretroviral therapy (ART)
Key exclusion criteria (2 listed)
- HIV positive subjects
- Subjects who cannot take Emtricitabine/tenofovir disoproxil combination tablet (FTC/TDF) due to contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of PrEP
Time frame: 24 months
Assess the impact of PrEP on the sexual and psychological health of PrEP users
4 secondary outcomes
Incidence of STIs
Time frame: 24 months
Drug compliance
Time frame: 24 months
HIV seroconversion
Time frame: 24 months
Drug resistance
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Olaug Olsen, MD PhD principal investigator
Oslo University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Sexually Transmitted Diseases, run by Oslo University Hospital at 9 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Johansen (23075840 ext. 47, jorgej@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of PrEP (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.