NCT05093036Completed
E-Health for Zero Infections - Facilitating Access to and Use of HIV Pre-Exposure Prophylaxis (PrEP) in the Netherlands
The EZI-PrEP Study: E-Health for Zero Infections - Facilitating Access to and Use of HIV Pre-Exposure Prophylaxis (PrEP) in the Netherlands
Source: ClinicalTrials.gov · Last updated 13 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 469 (actual)
- First submitted
- 13 Oct 2021
- Start date
- 21 Sept 2021
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Public Health Service of Amsterdam
- Diseases
- HIV
- NCT number
- NCT05093036
What you commit to
- Study type: Interventional
- Participants enrolled: 469
- From 21 Sept 2021 to the primary completion date, 31 Mar 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic use of medication that interacts with TFV/FTC e.g. NSAIDs.
Other illness
- HIV infection;
- Chronic or acute Hepatitis B virus infection;
- Other medical conditions that require special attention when using PrEP, such as osteoporosis or other bone diseases;
Lab values
- eGFR less than 60 mL/min/1.73m2;
Other
- Diminishing renal function:
- Other renal problems, as diagnosed by a physician and advised against using TFV;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Public Health Service of Amsterdam Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Public Health Service Gelderland-Zuid Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Public Health Service Rotterdam-Rijnmond Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Public Health Service Haaglanden Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.