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

December 10, 2024 updated by: Dr. Udi Davidovich, Public Health Service of Amsterdam

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
469

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence to PrEP regimen
Time Frame: 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.
18 months for each individual study participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Public Health Service of Amsterdam

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL74494.018.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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