Feasibility and impact of online HIV/STI screening addressed to men who have sex with men and transgender women users of pre-exposure prophylaxis (PrEP) in Spain (TESTATE PrEP) : a study protocol for a non-blinded randomised controlled trial
Agustí, Cristina (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Martínez Riveros, Héctor (Universitat Autònoma de Barcelona. Departament de Pediatria, Obstetrícia i Ginecologia i de Medicina Preventiva i Salut Pública)
García-Pérez, Jorge (Hospital Universitari Vall d'Hebron)
Descalzo Jorro, Vicente (Hospital Universitari Vall d'Hebron)
Fernandez Rivas, Gema (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Ramírez-Marinero, Aida (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
González, Maria Victoria (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Díaz, Yesika (Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública)
Montoro-Fernandez, Marcos (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Romano-deGea, Pol (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Araujo, Silvia G (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Muntada, Esteve (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Casabona-Barbarà, Jordi (Universitat Autònoma de Barcelona. Departament de Pediatria, Obstetrícia i Ginecologia i de Medicina Preventiva i Salut Pública)

Date:	2023
Abstract:	The objectives of the study are: to design and implement a pilot intervention to offer self-sampling kits to detect HIV, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Treponema pallidum (TP) among gay, bisexual and other men who have sex with men and transgender women users of pre-exposure prophylaxis (PrEP) as part of PrEP follow-up. To evaluate if the pilot intervention causes a reduction of the retention to PrEP follow-up among the target population. To analyse the capacity of the intervention to reduce the healthcare burden on the PrEP service. To evaluate the acceptability of the intervention among PrEP users and PrEP service healthcare workers and; to validate dried blood samples for treponemal and non-treponemal antibody detection using the Dual Path Platform syphilis screening and confirmatory assay compared with blood drawn by venous puncture. We will perform a non-blinded randomised controlled non-inferiority trial among PrEP users on follow-up. Participants on the control arm will follow the usual follow-up protocol with quarterly face-to-face visits where they will be tested for HIV and sexually transmitted infections (STIs). Participants in the experimental arm will alternate face-to-face meetings with online screening of HIV and STIs. The website will include a module for online follow-up visits of participants. Participants of the experimental arm will order self-sampling kits for HIV, CT, NG and TP through the website, will send the samples to the laboratory and check their results online. We will compare the retention to follow up and the healthcare burden in both arms. The acceptability of the intervention among participants and healthcare workers will be assessed. The project has been approved by the CEIC-HUGTIP (Reference: PI-22-051). Subjects will be included after giving their informed consent. Final conclusions and recommendations will be shared with stakeholders. Two publications in peer-reviewed journals are expected. .
Grants:	Instituto de Salud Carlos III PI21/01589
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	HIV & AIDS ; Sexually transmitted disease ; Clinical trial
Published in:	BMJ open, Vol. 13 (october 2023) , ISSN 2044-6055

DOI: 10.1136/bmjopen-2023-073459
PMID: 37844988

9 p, 1.3 MB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles