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.
HIV & AIDS
clinical trial
sexually transmitted disease
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
16 10 2023
16 10 2023
Historique:
medline:
23
10
2023
pubmed:
17
10
2023
entrez:
16
10
2023
Statut:
epublish
Résumé
The objectives of the study are: to design and implement a pilot intervention to offer self-sampling kits to detect HIV, 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 https://testate.org/ 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. NCT05752643.
Identifiants
pubmed: 37844988
pii: bmjopen-2023-073459
doi: 10.1136/bmjopen-2023-073459
pmc: PMC10582878
doi:
Banques de données
ClinicalTrials.gov
['NCT05752643']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e073459Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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