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 GGD.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is adherence to PrEP, determined by self-reported daily
data on pill-intake and sexual behavior during the first 18 months of
participation of each participant. Non-adherence is defined as a PrEP-less and
condom-less anal sex act with a casual partner.
Secondary outcome
Secondary outcomes include the incidence of HIV and Hepatitis C virus
infections, bacterial STIs, creatinine clearance, glycosuria and proteinuria,
retention in PrEP-care, psychosocial indicators, and acceptance and usability
of the internet-based PrEP service.
Background summary
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 and emtricitabine (PrEP). PrEP care is available for men
who have sex with men (MSM) and transgenderpersons (TGP) at low cost through
the centers for sexual health (CSH) of public health services (GGDs). Offering
PrEP care online and reducing the frequency of monitoring may increase access
to PrEP.
Study objective
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 GGD.
Study design
Randomised, non-blinded, controlled, non-inferiority trial.
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 biannualmonitoring at CSH; (3) internet-based
PrEP-care (i.e. video consultations and online-mediated testing for HIV, STIs
and renalfunction) with quarterly monitoring; (4) internet-based PrEP-care with
biannual monitoring. Each participant will be followed for 24 months.
Study burden and risks
All participants will be required to complete a brief daily online diary
regarding pill intake, sexual acts and mood and questionnaires on sexual
behavior, acceptability and usability of the service, and psychosocial
indicators. All participants will be asked to provide a dried blood spots (DBS)
from a finger prick at months 6 and 12. Participants with STI-related symptoms
or (mental) health issues are encouraged to contact the CSH regardless of the
timing for planned monitoring visits, but delayed diagnosis of asymptomatic
STIs could occur among those assigned to biannual monitoring. Overall, the
health risks of participants assigned to an intervention arm (arms 2, 3 and 4)
are minimally higher than those of participants receiving the standard-of-care.
Nieuwe Achtergracht 100
Amsterdam 1018 WT
NL
Nieuwe Achtergracht 100
Amsterdam 1018 WT
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05093036 |
| CCMO | NL74494.018.20 |