PMID- 37938875
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231125
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 12
DP  - 2023 Nov 8
TI  - 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).
PG  - e51023
LID - 10.2196/51023 [doi]
LID - e51023
AB  - BACKGROUND: Daily and event-driven HIV pre-exposure prophylaxis (PrEP) with oral 
      tenofovir-emtricitabine is highly effective to prevent HIV in men who have sex 
      with men (MSM). PrEP care generally consists of in-clinic monitoring every 3 
      months that includes PrEP dispensing, counseling, and screening for HIV and 
      sexually transmitted infections (STIs). However, the optimal frequency for 
      monitoring remains undetermined. Attending a clinic every 3 months for monitoring 
      may be a barrier for PrEP. Online-mediated PrEP care and reduced frequency of 
      monitoring may lower this barrier. OBJECTIVE: The primary objective of this study 
      is to establish the noninferiority of online PrEP care (vs in-clinic care) and 
      monitoring every 6 months (vs every 3 months). The secondary objectives are to 
      (1) examine differences between PrEP care modalities regarding incidences of 
      STIs, HIV infection, and hepatitis C virus infection; retention in PrEP care; 
      intracellular tenofovir-diphosphate concentration; and satisfaction, usability, 
      and acceptability of PrEP care modalities; and (2) evaluate associations of these 
      study outcomes with sociodemographic, behavioral, and psychological 
      characteristics. METHODS: This study is a 2x2 factorial, 4-arm, open-label, 
      multi-center, randomized, controlled, noninferiority trial. The 4 arms are (1) 
      in-clinic monitoring every 3 months, (2) in-clinic monitoring every 6 months, (3) 
      online monitoring every 3 months, and (4) online monitoring every 6 months. The 
      primary outcome is a condomless anal sex act with a casual partner not covered or 
      insufficiently covered by PrEP (ie, "unprotected act") as a proxy for HIV 
      infection risk. Eligible individuals are MSM, and transgender and gender diverse 
      people aged >/=18 years who are eligible for PrEP care at 1 of 4 participating 
      sexual health centers in the Netherlands. The required sample size is 442 
      participants, and the planned observation time is 24 months. All study 
      participants will receive access to a smartphone app, which contains a diary. 
      Participants are requested to complete the diary on a daily basis during the 
      first 18 months of participation. Participants will complete questionnaires at 
      baseline and 6, 12, 18, and 24 months. Dried blood spots will be collected at 6 
      and 12 months for assessment of intracellular tenofovir-diphosphate 
      concentration. Incidence rates of unprotected acts will be compared between the 
      online and in-clinic arms, and between the 6-month and 3-month arms. 
      Noninferiority will be concluded if the upper limit of the 2-sided 97.5% CI of 
      the incidence rate ratio is <1.8. RESULTS: The results of the main analysis are 
      expected in 2024. CONCLUSIONS: This trial will demonstrate whether online PrEP 
      care and monitoring every 6 months is noninferior to standard PrEP care in terms 
      of PrEP adherence. If noninferiority is established, these modalities may lower 
      barriers for initiating and continuing PrEP use and potentially reduce the 
      systemic burden for PrEP providers. TRIAL REGISTRATION: ClinicalTrials.gov 
      NCT05093036; https://tinyurl.com/28b8ndvj. INTERNATIONAL REGISTERED REPORT 
      IDENTIFIER (IRRID): DERR1-10.2196/51023.
CI  - (c)Marije L Groot Bruinderink, Anders Boyd, Liza Coyer, Sophie Boers, Laura Blitz, 
      Jean-Marie Brand, Hannelore M Gotz, Martijn Stip, Joey Woudstra, Kenneth Yap, 
      Koenraad Vermey, Amy Matser, Allard R Feddes, Vita W Jongen, Maria Prins, Elske 
      Hoornenborg, Frenk van Harreveld, Maarten F Schim van der Loeff, Udi Davidovich. 
      Originally published in JMIR Research Protocols 
      (https://www.researchprotocols.org), 08.11.2023.
FAU - Groot Bruinderink, Marije L
AU  - Groot Bruinderink ML
AUID- ORCID: 0009-0006-7365-8657
AD  - Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, 
      Netherlands.
AD  - Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.
FAU - Boyd, Anders
AU  - Boyd A
AUID- ORCID: 0000-0001-9512-8928
AD  - Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, 
      Netherlands.
AD  - HIV Monitoring Foundation, Amsterdan, Netherlands.
FAU - Coyer, Liza
AU  - Coyer L
AUID- ORCID: 0000-0001-5830-2982
AD  - Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, 
      Netherlands.
FAU - Boers, Sophie
AU  - Boers S
AUID- ORCID: 0009-0006-6676-657X
AD  - Department of Sexual Health, Public Health Service of Gelderland-Zuid, Nijmegen, 
      Netherlands.
FAU - Blitz, Laura
AU  - Blitz L
AUID- ORCID: 0009-0003-6695-0201
AD  - Department of Sexual Health, Public Health Service of Haaglanden, The Hague, 
      Netherlands.
FAU - Brand, Jean-Marie
AU  - Brand JM
AUID- ORCID: 0009-0003-7704-4896
AD  - Department of Sexual Health, Public Health Service of Haaglanden, The Hague, 
      Netherlands.
FAU - Gotz, Hannelore M
AU  - Gotz HM
AUID- ORCID: 0000-0002-1236-6224
AD  - Department of Infectious Diseases, Public Health Service of Rotterdam-Rijnmond, 
      Rotterdam, Netherlands.
AD  - Department of Public Health, Erasmus MC, University Medical Center, Rotterdam, 
      Netherlands.
FAU - Stip, Martijn
AU  - Stip M
AUID- ORCID: 0009-0008-0368-482X
AD  - Department of Infectious Diseases, Public Health Service of Rotterdam-Rijnmond, 
      Rotterdam, Netherlands.
FAU - Woudstra, Joey
AU  - Woudstra J
AUID- ORCID: 0009-0000-0722-8073
AD  - Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, 
      Netherlands.
FAU - Yap, Kenneth
AU  - Yap K
AUID- ORCID: 0009-0001-9371-5966
AD  - Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, 
      Netherlands.
FAU - Vermey, Koenraad
AU  - Vermey K
AUID- ORCID: 0000-0002-8349-9147
AD  - Aidsfonds - Soa Aids Nederland, Amsterdam, Netherlands.
FAU - Matser, Amy
AU  - Matser A
AUID- ORCID: 0000-0003-4291-1905
AD  - Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, 
      Netherlands.
AD  - Amsterdam Institute for Infection & Immunity, Department of Infectious Diseases, 
      Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
FAU - Feddes, Allard R
AU  - Feddes AR
AUID- ORCID: 0000-0002-3294-6242
AD  - Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.
FAU - Jongen, Vita W
AU  - Jongen VW
AUID- ORCID: 0000-0001-9538-1501
AD  - Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, 
      Netherlands.
AD  - HIV Monitoring Foundation, Amsterdan, Netherlands.
FAU - Prins, Maria
AU  - Prins M
AUID- ORCID: 0000-0003-2967-0289
AD  - Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, 
      Netherlands.
AD  - Amsterdam Institute for Infection & Immunity, Department of Infectious Diseases, 
      Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
FAU - Hoornenborg, Elske
AU  - Hoornenborg E
AUID- ORCID: 0000-0002-0512-2109
AD  - Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, 
      Netherlands.
AD  - Amsterdam Institute for Infection & Immunity, Department of Infectious Diseases, 
      Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
FAU - van Harreveld, Frenk
AU  - van Harreveld F
AUID- ORCID: 0000-0003-3717-2773
AD  - Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.
AD  - National Institute for Public Health and the Environment, Bilthoven, Netherlands.
FAU - Schim van der Loeff, Maarten F
AU  - Schim van der Loeff MF
AUID- ORCID: 0000-0002-4903-7002
AD  - Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, 
      Netherlands.
AD  - Amsterdam Institute for Infection & Immunity, Department of Infectious Diseases, 
      Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
FAU - Davidovich, Udi
AU  - Davidovich U
AUID- ORCID: 0000-0002-4921-0346
AD  - Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, 
      Netherlands.
AD  - Department of Psychology, University of Amsterdam, Amsterdam, Netherlands.
LA  - eng
SI  - ClinicalTrials.gov/NCT05093036
PT  - Journal Article
DEP - 20231108
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC10666015
OTO - NOTNLM
OT  - HIV prevention
OT  - MSM
OT  - Netherlands
OT  - acceptability
OT  - adherence
OT  - men who have sex with men
OT  - pre-exposure prophylaxis
OT  - randomized controlled trial
OT  - telemedicine
OT  - usability
COIS- Conflicts of Interest: UD received unrestricted research grants and speaker fees 
      from Gilead Sciences, paid to his institute. MFSvdL participated in Advisory 
      Boards of Merck Sharp & Dohme, for which fees were paid to his institute. MFSvdL 
      received a research grant from GlaxoSmithKline, paid to his institute. EH 
      received unrestricted research grants from Gilead Sciences, paid to her 
      institute. MP received unrestricted research grants and speaker/advisory fees 
      from Gilead Sciences and Merck Sharp & Dohme, all paid to her institute. All 
      other authors declare no competing interest.
EDAT- 2023/11/08 18:42
MHDA- 2023/11/08 18:43
PMCR- 2023/11/08
CRDT- 2023/11/08 12:08
PHST- 2023/07/20 00:00 [received]
PHST- 2023/09/18 00:00 [accepted]
PHST- 2023/09/15 00:00 [revised]
PHST- 2023/11/08 18:43 [medline]
PHST- 2023/11/08 18:42 [pubmed]
PHST- 2023/11/08 12:08 [entrez]
PHST- 2023/11/08 00:00 [pmc-release]
AID - v12i1e51023 [pii]
AID - 10.2196/51023 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2023 Nov 8;12:e51023. doi: 10.2196/51023.