E-Health for Zero Infections - facilitating access to and use of Pre-Exposure Prophylaxis (PrEP) in the Netherlands

Recruiting

Conditions: HIV
human immunodeficiency virus
10047438

Registration Number: NL-OMON54198

Lead Sponsor: GGD Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 442

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Aged 18 years or older;
• Meet the eligibility criteria of the NPP i.e. MSM or transgender persons who
in the 6 months prior to the PrEP-request/PrEP-consultation:
o Had anal sexual intercourse without a condom with a male partner with an
unknown HIV status, and/or;
o Had anal sexual intercourse without a condom with a male partner with a known
HIV-positive status and a detectable viral load, and/or;
o Was diagnosed with a rectal STI, and/or;
o Received a prescription for post-exposure prophylaxis (PEP);
• Living in the catchment area of one of the participating GGD regions;
• Have a smartphone, internet access and email address;
• Sufficient understanding of Dutch or English;

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• HIV infection;
• Acute of chronic Hepatitis B virus infection;
• Renal function problems:
o eGFR less than 60 mL/min/1.73m2;
o Other renal problems, as diagnosed by the physician;
• Use of medicines that interact with TDF/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 & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is adherence to PrEP, determined by self-reported daily<br /><br>data on pill-intake and sexual behavior during the first 18 months of<br /><br>participation of each participant. Non-adherence is defined as a PrEP-less and<br /><br>condom-less anal sex act with a casual partner. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include the incidence of HIV and Hepatitis C virus<br /><br>infections, bacterial STIs, creatinine clearance, glycosuria and proteinuria,<br /><br>retention in PrEP-care, psychosocial indicators, and acceptance and usability<br /><br>of the internet-based PrEP service.</p><br>