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

NCT05093036 | Completed DMC

• 1 other identifier: NL74494.018.20
• Study Type: interventional
• Target: 469
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV Infections

Keywords

Pre-Exposure Prophylaxis (PrEP); Prevention; E-Health

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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).

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).

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).

Other: Variations in PrEP care delivery at public health services

Interventions

Variations in PrEP care delivery at public health services OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Public Health Service of Amsterdam

Amsterdam, 1018 WT, Netherlands

Location

Public Health Service Gelderland-Zuid

Nijmegen, Netherlands

Location

Public Health Service Rotterdam-Rijnmond

Rotterdam, Netherlands

Location

Public Health Service Haaglanden

The Hague, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37938875 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Udi Davidovich, PhD

  Public Health Service of Amsterdam

  PRINCIPAL INVESTIGATOR

• Maarten Schim van der Loeff

  Public Health Service of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher (PhD)

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 26, 2021
• Study Start: September 21, 2021
• Primary Completion: March 31, 2024
• Study Completion: September 30, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4)