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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: Variations in PrEP care delivery at public health services

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 441
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marije Groot Bruinderink, MSc; Phone Number: 031205559414; Email: mgrootbruinderink@ggd.amsterdam.nl
• Study Contact Backup: Name: Udi Davidovich, PhD; Phone Number: 0031205555411; Email: UDavidovich@ggd.amsterdam.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1018 WT
    • Public Health Service of Amsterdam
  • Den Haag, Netherlands
    • Public Health Service Haaglanden
  • Nijmegen, Netherlands
    • Public Health Service Gelderland-Zuid
  • Rotterdam, Netherlands
    • Public Health Service Rotterdam-Rijnmond

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1: routine PrEP care at the CSH, monitoring 4 times per year (standard-of-care); 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).
Experimental: Arm 2: routine PrEP care at the CSH, monitoring 2 times per year; 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).	Other: Variations in PrEP care delivery at public health services; Variations on routine PrEP care at the Public Health Services in the Netherlands: online PrEP care and reduced frequency of monitoring
Experimental: Arm 3: online PrEP care, monitoring 4 times per year; 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).	Other: Variations in PrEP care delivery at public health services; Variations on routine PrEP care at the Public Health Services in the Netherlands: online PrEP care and reduced frequency of monitoring
Experimental: Arm 4: online PrEP care, monitoring 2 times per year; 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).	Other: Variations in PrEP care delivery at public health services; Variations on routine PrEP care at the Public Health Services in the Netherlands: online PrEP care and reduced frequency of monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to PrEP regimen	Non-adherence is defined as a PrEP-less and condom-less anal sex act with a casual partner, termed an unprotected act (UA). Self-reported daily data on sexual behaviour, pill intake and condom use are recorded in an electronic diary. Using these data, we will count the number of UAs (n), and the person-months at risk (pmar) per person; this will yield the incidence rate (IR) per person month (= n / pmar). This will be done for each study arm separately.	18 months for each individual study participant

Collaborators and Investigators

• Sponsor: Public Health Service of Amsterdam
• Collaborators: The National Institute for STI and Aids Control in the Netherlands (Soa Aids Nederland); Public Health Service Rotterdam-Rijnmond; Public Health Service Haaglanden; Public Health Service Gelderland-Zuid; Stichting Aidsfonds; DC Pharmacy of DC Klinieken
• Investigators: Principal Investigator: Udi Davidovich, PhD, Public Health Service of Amsterdam; Principal Investigator: Maarten Schim van der Loeff, Public Health Service of Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Prevention; Pre-Exposure Prophylaxis (PrEP); E-Health
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: NL74494.018.20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No