HIV human immunodeficiency virus
Conditions
Interventions
The study takes place in four GGD regions in the Netherlands: Amsterdam,
Haaglanden, Rotterdam-Rijnmond and Gelderland-Zuid.Participants will be
assigned to one of four arms: (1) routine care with q
(2) routine care with biannualmonitoring at CSH
(3) internet-based
PrEP-care (i.e. video consultations and online-mediated testing for HIV, STIs
and renalfunction) with quarterly monitoring
(4) internet-based PrEP-care with
biannual monitoring. Each participant will be followed for 24 months.
Sponsors
GGD Amsterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Aged 18 years or older; • Meet the eligibility criteria of the NPP i.e. MSM or transgender persons who in the 6 months prior to the PrEP-request/PrEP-consultation: o Had anal sexual intercourse without a condom with a male partner with an unknown HIV status, and/or; o Had anal sexual intercourse without a condom with a male partner with a known HIV-positive status and a detectable viral load, and/or; o Was diagnosed with a rectal STI, and/or; o Received a prescription for post-exposure prophylaxis (PEP); • Living in the catchment area of one of the participating GGD regions; • Have a smartphone, internet access and email address; • Sufficient understanding of Dutch or English;
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • HIV infection; • Acute of chronic Hepatitis B virus infection; • Renal function problems: o eGFR less than 60 mL/min/1.73m2; o Other renal problems, as diagnosed by the physician; • Use of medicines that interact with TDF/FTC e.g. NSAIDs. • Other medical conditions that require special attention when using PrEP such as osteoporosis or other bone diseases; • Unlikely, in the opinion of the clinician, to comply with the study requirements or procedures; • Participating in another study that affects the primary or secondary outcome measures of our study; • Investigators or otherwise dependent persons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is adherence to PrEP, determined by self-reported daily data on pill-intake and sexual behavior during the first 18 months of participation of each participant. Non-adherence is defined as a PrEP-less and condom-less anal sex act with a casual partner. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include the incidence of HIV and Hepatitis C virus infections, bacterial STIs, creatinine clearance, glycosuria and proteinuria, retention in PrEP-care, psychosocial indicators, and acceptance and usability of the internet-based PrEP service. | — |
Countries
Netherlands
Outcome results
None listed