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Pilot randomised controlled trial of a patient navigation intervention to enhance engagement in the PrEP continuum among young Latino MSM: a protocol paper.
- Source :
-
BMJ open [BMJ Open] 2021 May 26; Vol. 11 (5), pp. e040955. Date of Electronic Publication: 2021 May 26. - Publication Year :
- 2021
-
Abstract
- 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.<br />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.<br />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.<br />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.<br />Competing Interests: Competing interests: None declared.<br /> (© 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.)
- Subjects :
- Adolescent
Adult
Hispanic or Latino
Homosexuality, Male
Humans
Male
Pilot Projects
Randomized Controlled Trials as Topic
Young Adult
Anti-HIV Agents therapeutic use
HIV Infections drug therapy
HIV Infections prevention & control
Patient Navigation
Pre-Exposure Prophylaxis
Sexual and Gender Minorities
Subjects
Details
- Language :
- English
- ISSN :
- 2044-6055
- Volume :
- 11
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- BMJ open
- Publication Type :
- Academic Journal
- Accession number :
- 34039570
- Full Text :
- https://doi.org/10.1136/bmjopen-2020-040955