E-Health for Zero Infections - Facilitating Access to and Use of HIV Pre-Exposure Prophylaxis (PrEP) in The Netherlands (EZI-PREP)
HIV Infections
About this trial
This is an interventional health services research trial for HIV Infections focused on measuring Pre-Exposure Prophylaxis (PrEP), Prevention, E-Health
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or older;
Meeting the eligibility criteria of the NPP i.e. being a MSM or transgender persons who in the 6 months prior to the PrEP-request/PrEP-consultation:
- Had anal sexual intercourse without a condom with a male partner with an un-known HIV status, and/or;
- Had anal sexual intercourse without a condom with a male partner with a known HIV-positive status and a detectable viral load, and/or;
- Was diagnosed with a rectal STI, and/or;
- Received a prescription for post-exposure prophylaxes (PEP);
- Living in the catchment area of one of the participating GGD regions;
- Having a smartphone, internet access and email address;
- Sufficient understanding of Dutch or English; and
- Signed informed consent.
Exclusion Criteria:
- HIV infection;
- Chronic or acute Hepatitis B virus infection;
- Diminishing renal function:
- eGFR less than 60 mL/min/1.73m2;
- Other renal problems, as diagnosed by a physician and advised against using TFV;
- Chronic use of medication that interacts with TFV/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.
Sites / Locations
- Public Health Service of Amsterdam
- Public Health Service Haaglanden
- Public Health Service Gelderland-Zuid
- Public Health Service Rotterdam-Rijnmond
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
Arm 1: routine PrEP care at the CSH, monitoring 4 times per year (standard-of-care)
Arm 2: routine PrEP care at the CSH, monitoring 2 times per year
Arm 3: online PrEP care, monitoring 4 times per year
Arm 4: online PrEP care, monitoring 2 times per year
Study participants in arm 1 follow routine care procedures, i.e. the number of monitoring visits is four times a year. Experienced PrEP users: first monitoring visit is three months after the enrolment into the study. PrEP-naïve participants: first monitoring visit is one month after enrolment in the study and start of PrEP use. The second monitoring visit is 2 months after the first monitoring contact (3 months after enrolment).
Study participants in arm 2 follow routine care procedures but with a reduced frequency of monitoring visits, i.e. the number of monitoring visits is reduced from four to two times a year. Timing of the first monitoring visit differs per PrEP user type: Experienced PrEP users: first monitoring visit is six months after the enrolment into the study. PrEP-naïve participants: first monitoring visit is one month after enrolment in the study and start of PrEP use. The second monitoring visit is five months after the first monitoring visit (6 months after enrolment).
Study participants in arm 3 receive internet-based PrEP care, i.e. video consultations and online-mediated testing for HIV, STIs and renal function, online PrEP ordering and (at home) delivery of PrEP. Monitoring occurs four times per year. Experienced PrEP users: first monitoring contact is three months after the enrolment into the study. PrEP-naïve participants: first monitoring contact is one month after enrolment in the study and start of PrEP use. The second monitoring visit is 2 months after the first monitoring contact (3 months after enrolment).
Study participants in arm 4 receive internet-based PrEP care, i.e. video consultations and online-mediated testing for HIV, STIs and renal function, online PrEP ordering and (at home) delivery of PrEP. Monitoring occurs two times per year. Experienced PrEP users: first monitoring contact is six months after the enrolment into the study. PrEP-naïve participants: first monitoring contact is one month after enrolment in the study and start of PrEP use. The second monitoring visit is five months after the first monitoring contact (6 months after enrolment).