An observational study in Hiv, Sexually Transmitted Diseases and Mental Health Wellness 1, sponsored by Oslo University Hospital. Status unknown at 9 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by Oslo University Hospital · Observational
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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.
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:
524 studies on the registry are indexed under Sexually Transmitted Diseases; 78 are open to participants now.
This study's planned enrollment of 500 is below the median of 576 across 92 observational studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Compared within Sexually Transmitted Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Men who have sex with men (MSM) and transgender persons;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject offered to start PrEP treatment in routine clinical practice
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.
Impact of PrEP
Assess the impact of PrEP on the sexual and psychological health of PrEP users
Time frame: 24 months
Incidence of STIs
Incidence of sexually transmitted infections (STIs) in PrEP users compared to those not taking PrEP
Time frame: 24 months
Drug compliance
Assessment of drug compliance
Time frame: 24 months
HIV seroconversion
Incidence of HIV seroconversion despite PrEP
Time frame: 24 months
Drug resistance
Frequency and development of drug resistance in subjects who HIV-seroconvert
Time frame: 24 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Oct 2017 (actual). Primary completion is estimated for Dec 2020, 38 months after the start.
Of 42 non-industry observational studies under Sexually Transmitted Diseases, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 57. This study's planned 38 months is above that.
Counting every sponsor, half of 47 studies reached it within 26 months; a quarter within 15 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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