E-Health for Zero Infections - Facilitating Access to and Use of HIV Pre-Exposure Prophylaxis (PrEP) in the Netherlands (EZI-PREP)

Public Health Service of Amsterdam

Status: Completed

Conditions: HIV Infections

Treatments: Other: Variations in PrEP care delivery at public health services

Study type: Interventional

Funder types: Other

Identifiers

NCT05093036

NL74494.018.20

Details and patient eligibility

About

Offering PrEP care online and reducing the frequency of monitoring may increase access to HIV PrEP. The objective of this study is to assess the non-inferiority of an internet-based HIV PrEP-service and reduced frequency of monitoring visits in comparison to standard-of-care at the Public Health Service in 4 regions in the Netherlands: Amsterdam, Rotterdam-Rijnmond, Haagland and Gelderland-Zuid.

Full description

Rationale: The population impact of HIV pre-exposure prophylaxis (PrEP) largely depends on the uptake and consistent use of PrEP by people at high risk for HIV infection. In the Dutch National PrEP Programme (NPP), PrEP care consists of quarterly monitoring visits, which includes testing for HIV, sexually transmitted infections (STIs) and renal function, and provision of combination tablets of tenofovir disoproxil fumarate and emtricitabine. PrEP care is available for men who have sex with men (MSM) and transgender persons (TGP) at low cost through the centers for sexual health (CSH) of public health services (GGD's). Offering PrEP care online and reducing the frequency of monitoring may increase access to PrEP.

Objective: To assess the non-inferiority of an internet-based HIV PrEP-service and reduced frequency of monitoring visits in comparison to standard-of-care at the Public Health Service.

Study design: Randomised, non-blinded, controlled, parallel group, non-inferiority trial.

Study population: MSM and TGP of 18 years of age or older who are eligible for HIV PrEP according to NPP guidelines based on self-reported sexual behavior indicating HIV risk.

Intervention: 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 quarterly monitoring at CSH; (2) routine care with biannual monitoring at CSH; (3) internet-based PrEP-care (i.e. video consultations and online-mediated testing for HIV, STIs and renal function) with quarterly monitoring; (4) internet-based PrEP-care with biannual monitoring. Each participant will be followed for 18 months.

Main study parameters/endpoints: The primary outcome is adherence to PrEP, determined by self-reported daily data on pill-intake and sexual behavior. Non-adherence is defined as a PrEP-less and condom-less anal sex act with a casual partner. Secondary outcomes include the incidence of HIV and Hepatitis C virus infections and bacterial STIs; creatinine clearance, glycosuria and proteinuria; retention in PrEP-care; psychosocial health; and acceptance and usability of the internet-based PrEP service.

Enrollment: 469 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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469 participants in 4 patient groups

Arm 1: routine PrEP care at the CSH, monitoring 4 times per year (standard-of-care)

No Intervention group

Description:

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).

Arm 2: routine PrEP care at the CSH, monitoring 2 times per year

Experimental group

Description:

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).

Treatment:

Other: Variations in PrEP care delivery at public health services

Arm 3: online PrEP care, monitoring 4 times per year

Experimental group

Description:

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).

Treatment:

Other: Variations in PrEP care delivery at public health services

Arm 4: online PrEP care, monitoring 2 times per year

Experimental group

Description:

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).

Treatment:

Other: Variations in PrEP care delivery at public health services