HIV
Conditions
Interventions
Daily or Intermittent PrEP (modality at choice of participant)
Sponsors
Academic Medical Center is sponsor. Center for study visits: Public Health service Amsterdam (GGD Amsterdam)
Eligibility
Inclusion criteria
Inclusion criteria: All 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 criteria
Exclusion criteria: One 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To 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
| Measure | Time frame |
|---|---|
| A. 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 | — |
Contacts
Public ContactElske Hoornenborg
GGD Amsterdam
Outcome results
None listed