search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


AMPrEP (Amsterdam PrEP project)


- candidate number22790
- NTR NumberNTR5411
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-aug-2015
- Secondary IDs2014_407 
- Public TitleAMPrEP (Amsterdam PrEP project)
- Scientific TitleBiomedical interventions for HIV prevention in MSM in Amsterdam: a demonstration project
- ACRONYMAMPrEP (Amsterdam PrEP project)
- hypothesisPublic Health Service of Amsterdam (PHSA) can inform HIV-negative men who have sex with men (MSM) at high risk for HIV infection about and provide them with daily or intermittent pre-exposure prophylaxis (PrEP), to be taken as part of a comprehensive HIV risk reduction package. MSM can adequately make a choice between the two different intervention strategies and adhere to the chosen strategy. This comprehensive HIV prevention program has a good acceptability, feasibility and usability.
- Healt Condition(s) or Problem(s) studiedHIV infection, Prevention, Prophylaxis
- Inclusion criteriaAll of the following:

1. Male or transgender, age 18 years or more
2. MSM
3. Completed HIV and STI screening
4. HIV negative by 4th generation Elisa antigen/antibody test.
5. Willing and able to comply to project visit schedule and procedures
6. Willing and able to give written informed consent
7. Sufficient understanding of Dutch or English

AND at least one of the following:

1. One or more documented STI (urethral or anal chlamydia or gonorrhoea, primary or secondary syphilis) in the last 6 months (either at STI clinic or a documented infection diagnosed elsewhere)
2. UAI with casual partners in the last 6 months
3. Received PEP after sexual risk incident in the last 6 months
4. HIV positive partner with unknown or detectable viral load
- Exclusion criteriaOne of the following:

1. Signs or symptoms of acute HIV infection1
2. Hepatitis B infection (i.e. HbsAg positive)
3. Creatinine clearing (using cockroft gault formula) < 60 ml/min
4. Concurrent use of nephrotoxic medication (aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2)
5. Hypersensitivity for one of the components of fixed combination tablet containing tenofovir and emtricitabine2
6. Unlikely, in the opinion of the clinician, to comply with trial schedule
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 3-aug-2015
- planned closingdate1-jun-2018
- Target number of participants370
- InterventionsDaily or Intermittent PrEP (modality at choice of participant)
- Primary outcomeTo investigate the uptake, acceptability and usability of a comprehensive HIV infection prevention program for high-risk MSM through 2 different intervention strategies: daily PrEP and on demand PrEP, combined with intensified standard care at the PHSA.
- Secondary outcomeA. Adherence
To assess the adherence of the participants to medication schedules and follow-up regimes
To assess factors predicting adherence
To assess barriers for adherence
To assess the number of attended scheduled clinic visits

B. Adverse events
To assess the incidence of serious adverse reactions attributable to the antiretroviral medication
To assess the incidence of adverse events that lead to interruption or cessation of antiretroviral medication
To assess changes in renal function

C. HIV infection
To assess the HIV incidence rate in the two project arms
D. Viral resistance
To assess HIV-drug resistance in case of incident HIV infection

E. Risk behaviour
To assess trends in self-reported risk behaviour

F. STIs
To determine trends in incidence rate of STIs

G. Barriers and motives of choice of intervention

To identify barriers and motives of choice of intervention and participant satisfaction with their choice

H. General well-being
To assess self-perceived health and psychosocial well-being including sexual health
- Timepointsend 2016: baseline characteristic and interim analyses
end 2018: final evaluation
- Trial web siteggd.amsterdam.nl/prep
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Elske Hoornenborg
- CONTACT for SCIENTIFIC QUERIES Elske Hoornenborg
- Sponsor/Initiator GGD Amsterdam, Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
AIDS fund, GGD Amsterdam, Rijksinstituut voor Volksgezondheid en Milieu (RIVM), Gilead
- Publications
- Brief summaryHypothesis: Public Health Service of Amsterdam (PHSA) can inform HIV-negative men who have sex with men (MSM) at high risk for HIV infection about and provide them with daily or intermittent pre-exposure prophylaxis (PrEP), to be taken as part of a comprehensive HIV risk reduction package. MSM can adequately make a choice between the two different intervention strategies and adhere to the chosen strategy. This comprehensive HIV prevention program has a good acceptability, feasibility and usability.

Objective: To investigate the uptake, acceptability and usability of a comprehensive HIV infection prevention program for high-risk MSM through 2 different intervention strategies (i.e. daily or intermittent PrEP) at the PHSA.

Study design: Evaluation study of a demonstration project of 2 different HIV prevention strategies (daily or intermittent PrEP), as part of a comprehensive HIV prevention program. Study population: Men who have sex with men at increased risk for HIV (i.e. diagnosed with syphilis, urethral or rectal chlamydia or gonorrhoea within the last six months, reporting unprotected anal intercourse (UAI) with casual partners within the last six months, received PEP within last six months or having a HIV positive partner with unknown or detectable viral load in the last six months).

Intervention: Demonstration project with two arms: one group will receive daily PrEP and the second group will be provided with intermittent PrEP (i.e. 2 tablets between 24 and 2 hours before sexual contact followed by one tablet every 24 hours until 48 hours after the last sexual contact). After counselling, participants can choose an intervention. In addition, participants are allowed to switch between arms.

Main study parameters/endpoints: We will investigate uptake, acceptability, and usability of daily and intermittent PrEP, medication adherence, adverse events, behavioural disinhibition (i.e. increase in risk behaviour and in incidence of STIs), HIV infection and resistance.

Timeline: Start inclusion1 August 2015. End of inclusion: 1 November 2017. End of study interventions: 1 June 2018. End of follow-up: 1 December 2018.
- Main changes (audit trail)
- RECORD24-aug-2015 - 28-okt-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl