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

Sponsor

Public Health Service of Amsterdam (Other)

Overall Status

Recruiting

CT.gov ID

NCT05093036

Collaborator

Public Health Service Rotterdam-Rijnmond (Other), Public Health Service Haaglanden (Other), Public Health Service Gelderland-Zuid (Other), The National Institute for STI and Aids Control in the Netherlands (Soa Aids Nederland) (Other), Stichting Aidsfonds (Other), DC Pharmacy of DC Klinieken (Other)

532

Enrollment

Locations

Arms

30.3

Anticipated Duration (Months)

133

Patients Per Site

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Other: Variations in PrEP care delivery at public health services	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

532 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

We will implement a multi-center, four-arm, non-inferiority randomised controlled trial to evaluate online PrEP care and/or a reduced schedule of monitoring visits against routine (face-to-face) PrEP care at the Centers of Sexual Health (CSH) of the Public Health Services (PHS) (standard-of-care). After eligibility screening and assessment, study participants are randomized (1:1:1:1) to the standard-of-care arm (i.e. location: CSH; 4 annual monitoring visits) or one of three interventions arms: arm 2 (location: CSH; 2 annual monitoring visit), arm 3 (location: online; 4 annual monitoring visits), arm 4 (location: online; 2 annual monitoring visits). In the randomization process, participants will be stratified based on PrEP experience (PrEP-naïve or experienced) and PHS catchment area (4 regions). In each arm, we aim to include at least 25% PrEP-naïve participants.We will implement a multi-center, four-arm, non-inferiority randomised controlled trial to evaluate online PrEP care and/or a reduced schedule of monitoring visits against routine (face-to-face) PrEP care at the Centers of Sexual Health (CSH) of the Public Health Services (PHS) (standard-of-care). After eligibility screening and assessment, study participants are randomized (1:1:1:1) to the standard-of-care arm (i.e. location: CSH; 4 annual monitoring visits) or one of three interventions arms: arm 2 (location: CSH; 2 annual monitoring visit), arm 3 (location: online; 4 annual monitoring visits), arm 4 (location: online; 2 annual monitoring visits). In the randomization process, participants will be stratified based on PrEP experience (PrEP-naïve or experienced) and PHS catchment area (4 regions). In each arm, we aim to include at least 25% PrEP-naïve participants.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Sep 21, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Adherence to PrEP regimen [18 months for each individual study participant]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Public Health Service of Amsterdam	Amsterdam	Netherlands	1018 WT
2	Public Health Service Haaglanden	Den Haag	Netherlands
3	Public Health Service Gelderland-Zuid	Nijmegen	Netherlands
4	Public Health Service Rotterdam-Rijnmond	Rotterdam	Netherlands

Sponsors and Collaborators

Public Health Service of Amsterdam
Public Health Service Rotterdam-Rijnmond
Public Health Service Haaglanden
Public Health Service Gelderland-Zuid
The National Institute for STI and Aids Control in the Netherlands (Soa Aids Nederland)
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