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

HIV Infections Clinical Trial

— EZI-PREP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05093036
• Other study ID #: NL74494.018.20
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 21, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: Public Health Service of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 in the Netherlands: Amsterdam, Rotterdam-Rijnmond, Haagland and Gelderland-Zuid.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 441
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections

Intervention

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

Locations

Country	Name	City	State
Netherlands	Public Health Service of Amsterdam	Amsterdam
Netherlands	Public Health Service Haaglanden	Den Haag
Netherlands	Public Health Service Gelderland-Zuid	Nijmegen
Netherlands	Public Health Service Rotterdam-Rijnmond	Rotterdam

Sponsors (7)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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