Pilot randomised controlled trial of a patient navigation intervention to enhance engagement in the PrEP continuum among young Latino MSM: a protocol paper.

Autor: Blashill AJ; Department of Psychology, San Diego State University, San Diego, California, USA.; SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, California, USA., Gordon JR; SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, California, USA., Rojas SA; Family Health Centers of San Diego, San Diego, California, USA., Ramers CB; Family Health Centers of San Diego, San Diego, California, USA., Lin CD; Department of Psychology, San Diego State University, San Diego, California, USA., Carrizosa CM; San Diego State University Research Foundation, San Diego, California, USA., Nogg KA; San Diego State University Research Foundation, San Diego, California, USA., Lamb KM; Department of Psychology, San Diego State University, San Diego, California, USA., Lucido NC; Department of Psychology, San Diego State University, San Diego, California, USA., Jones IJ; Department of Psychology, San Diego State University, San Diego, California, USA., Rivera D; Department of Psychology, San Diego State University, San Diego, California, USA., Cobian Aguilar RA; Department of Psychology, San Diego State University, San Diego, California, USA., Brady JP; SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, California, USA., Fuentes M; Family Health Centers of San Diego, San Diego, California, USA., Wells KJ; Department of Psychology, San Diego State University, San Diego, California, USA kwells@mail.sdsu.edu.; SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, California, USA.
Jazyk: angličtina
Zdroj: BMJ open [BMJ Open] 2021 May 26; Vol. 11 (5), pp. e040955. Date of Electronic Publication: 2021 May 26.
DOI: 10.1136/bmjopen-2020-040955
Abstrakt: Introduction: Men who have sex with men (MSM) are one of the most at-risk group for contracting HIV in the USA. However, the HIV epidemic impacts some groups of MSM disproportionately. Latino MSM comprise 25.1% of new HIV infections among MSM between the ages of 13 and 29 years. The daily medication tenofovir/emtricitabine was approved by the Food and Drug Administration for pre-exposure prophylaxis (PrEP) in 2012 and has demonstrated strong efficacy in reducing HIV acquisition.
Methods and Analysis: Through extensive formative research, this study uses a pilot randomised controlled trial design and will examine the feasibility and acceptability of a patient navigation intervention designed to address multiple barriers to improve engagement in the PrEP continuum among 60 Latino MSM between the ages of 18 and 29 years. The patient navigation intervention will be compared with usual care plus written information to evaluate the feasibility and acceptability of the intervention and study methods and the intervention's potential in improving PrEP continuum behaviours. The results will be reviewed for preparation for a future full-scale efficacy trial.
Ethics and Dissemination: This study was approved by the institutional review board at San Diego State University and is registered at ClinicalTrials.gov. The intervention development process, plan and the results of this study will be shared through peer-reviewed journal publications, conference presentations and healthcare system and community presentations.
Registration Details: Registered under the National Institutes of Health's ClinicalTrials.gov (NCT04048382) on 7 August 2019 and approved by the San Diego State University (HS-2017-0187) institutional review board. This study began on 5 August 2019 and is estimated to continue through 31 March 2021. The clinical trial is in the pre-results stage.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze: MEDLINE