HIV InfectionsEZI-PREPNCT05093036

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

A study testing Variations in PrEP care delivery at public health services in people with HIV Infections, run by Public Health Service of Amsterdam at 4 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Variations in PrEP care delivery at public health services
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 469 participants
Where: 4 sitesNetherlands
Study dates: 21 Sep 2021to 30 Sep 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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);

Show all 10Show fewer

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.

Who cannot join

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.

Show all 10Show fewer

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 locations and contacts

4 sites in 1 country.

Netherlands4 sites

Public Health Service of Amsterdam
Amsterdam, 1018 WT
Public Health Service Gelderland-Zuid
Nijmegen
Public Health Service Rotterdam-Rijnmond
Rotterdam
Public Health Service Haaglanden
The Hague

Other trials in Netherlands

About this study

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

Read the 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.

Conditions: HIV Infections
Being tested: Variations in PrEP care delivery at public health services
Keywords: Pre-Exposure Prophylaxis (PrEP), Prevention, E-Health
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Variations in PrEP care delivery at public health servicesOther
Variations on routine PrEP care at the Public Health Services in the Netherlands: online PrEP care and reduced frequency of monitoring

Study groups in NCT05093036
Study group	Role	What they receive
Arm 1: routine PrEP care at the CSH, monitoring 4 times per year (standard-of-care)	No intervention	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	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). Receives: Other: Variations in PrEP care delivery at public health services
Arm 3: online PrEP care, monitoring 4 times per year	Experimental	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). Receives: Other: Variations in PrEP care delivery at public health services
Arm 4: online PrEP care, monitoring 2 times per year	Experimental	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). Receives: Other: Variations in PrEP care delivery at public health services

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 18 months for each individual study participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 202130 Sep 2024

First posted26 Oct 2021
Study start21 Sep 2021
Primary completion31 Mar 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 469 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05093036
Sponsor's protocol ID: NL74494.018.20
Acronym: EZI-PREP
Status last verified: Dec 2024
First submitted: 13 Oct 2021
Last updated: 13 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wijstma ES, Groot Bruinderink ML, Jongen VW, Boyd AC, Blitz L, van Bokhoven C, Woudstra J, Vermey K, Boers S, Gotz HM, van Harreveld F, Prins M, Hoornenborg E, Davidovich U, Schim van der Loeff MF. Impact of reduced-frequency monitoring among users of HIV pre-exposure prophylaxis on sexually transmitted infections and associated care: secondary outcomes of a randomized controlled trial. BMC Med. 2026 Jun 4. doi: 10.1186/s12916-026-04949-y. Online ahead of print.
PubMed 42243843
Groot Bruinderink ML, Boyd A, Coyer L, Boers S, Blitz L, Brand JM, Gotz HM, Stip M, Woudstra J, Yap K, Vermey K, Matser A, Feddes AR, Jongen VW, Prins M, Hoornenborg E, van Harreveld F, Schim van der Loeff MF, Davidovich U. Online-Mediated HIV Pre-exposure Prophylaxis Care and Reduced Monitoring Frequency for Men Who Have Sex With Men: Protocol for a Randomized Controlled Noninferiority Trial (EZI-PrEP Study). JMIR Res Protoc. 2023 Nov 8;12:e51023. doi: 10.2196/51023.
PubMed 37938875

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05093036
Acronym / sponsor ID: EZI-PREP / NL74494.018.20
Conditions: HIV Infections
Keywords: Pre-Exposure Prophylaxis (PrEP), Prevention, E-Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 469 participants (actual)
Lead sponsor: Public Health Service of AmsterdamOther government
Collaborators: 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
Study start: 21 Sep 2021 (actual)
Primary completion: 31 Mar 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 26 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
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.

Arm	Type	Receives
Arm 1: routine PrEP care at the CSH, monitoring 4 times per year (standard-of-care)	No intervention	–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	Other: Variations in PrEP care delivery at public health servicesStudy 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).
Arm 3: online PrEP care, monitoring 4 times per year	Experimental	Other: Variations in PrEP care delivery at public health servicesStudy 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).
Arm 4: online PrEP care, monitoring 2 times per year	Experimental	Other: Variations in PrEP care delivery at public health servicesStudy 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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:
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

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Variations in PrEP care delivery at public health servicesVariations on routine PrEP care at the Public Health Services in the Netherlands: online PrEP care and reduced frequency of monitoring	Other	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

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
Derived from this study: PubMed 42243843Wijstma ES, Groot Bruinderink ML, Jongen VW, Boyd AC, Blitz L, van Bokhoven C, Woudstra J, Vermey K, Boers S, Gotz HM, van Harreveld F, Prins M, Hoornenborg E, Davidovich U, Schim van der Loeff MF. Impact of reduced-frequency monitoring among users of HIV pre-exposure prophylaxis on sexually transmitted infections and associated care: secondary outcomes of a randomized controlled trial. BMC Med. 2026 Jun 4. doi: 10.1186/s12916-026-04949-y. Online ahead of print.
Derived from this study: PubMed 37938875Groot Bruinderink ML, Boyd A, Coyer L, Boers S, Blitz L, Brand JM, Gotz HM, Stip M, Woudstra J, Yap K, Vermey K, Matser A, Feddes AR, Jongen VW, Prins M, Hoornenborg E, van Harreveld F, Schim van der Loeff MF, Davidovich U. Online-Mediated HIV Pre-exposure Prophylaxis Care and Reduced Monitoring Frequency for Men Who Have Sex With Men: Protocol for a Randomized Controlled Noninferiority Trial (EZI-PrEP Study). JMIR Res Protoc. 2023 Nov 8;12:e51023. doi: 10.2196/51023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Udi Davidovich, PhD principal investigator

Public Health Service of Amsterdam

Maarten Schim van der Loeff principal investigator

Public Health Service of Amsterdam

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Variations in PrEP care delivery at public health services in people with HIV Infections, run by Public Health Service of Amsterdam at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to PrEP regimen (time frame: 18 months for each individual study participant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05093036, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.